rem-I - ! vuunovibh-o‘#uh,w A ‘1’. :I‘T léahu‘. .n; 15.2". 3 07). . 2:? . 23w . :....I.. J. I... .. a. 4.. .... .1: . .. . .. 2353...“; . .. .£,s..u,...o..n..... :4... Ga. ; _ 1.x (I. . r ..f 3.1. $35.12. 7, 5 It.” thus in} ' g; ‘1’ 45/1) LIBRARY Michigan State University This is to certify that the thesis entitled CHILDREN WITH ASTHMA AT A MICHIGAN HOSPITAL EMERGENCY DEPARTMENT: DO THEIR CARE AND MANAGEMENT ADHERE TO THE NAEPP GUIDELINES FOR ASTHMA? presented by Susan Rose Strahlendorf Bohm has been accepted towards fulfillment of the requirements for the Master of degree in Epidemiology Science Major Professor’s Signature July 1, 2003 Date MSU is an Affirmative Action/Equal Opportunity Institution PLACE IN RETURN BOX to remove this checkout from your record. TO AVOID FINES return on or before date due. MAY BE RECALLED with earlier due date if requested. DATE DUE DATE DUE DATE DUE 6I01 c'JCIFlC/DatoDuepss-p. 15 CHILDREN WITH ASTHMA AT A MICHIGAN HOSPITAL EMERGENCY DEPARTMENT: D0 THEIR CARE AND MANAGEMENT ADHERE TO THE NAEPP GUIDELINES FOR ASTHMA? By Susan Rose Strahlendorf Bohm A THESIS Submitted to Michigan State University in partial fulfillment of the requirements for the degree of MASTER OF SCIENCE Department of Epidemiology College of Human Medicine 2003 ABSTRACT CHILDREN WITH ASTHMA AT A MICHIGAN HOSPITAL EMERGENCY DEPARTMENT: DO THEIR CARE AND MANAGEMENT ADHERE TO THE NAEPP GUIDELINES FOR ASTHMA? By Susan Rose Strahlendorf Bohm In a single case cohort study of children with acute asthma at an emergency department, seven measures of their asthma we and management are compared with the NAEPP Guidelines. The relationship between symptom-based dnronic severity and asthma outcomes are examined. Parents of 139 children 2—17 years with acute asthma were interviewed at an urban Michigan emergency department and at two weeks after discharge. The mean age of the chilcren was 8.410] years, 47% had health insurance through Medicaid, and 95% had a primary care provider. The chronic severity of 48% of the cohort was classified as mild intermittent Of seven recommendations, only the use of inhaled corticosteroids and a consultation with an asthma specialist in the past year shomd a statistically significant relationship with severity. An estimated 19% of patients with moderate to severe persistent asthma were not taking any long-acting convol medication. No correlation was found between chronic and acute severity. Gaps in adherence to the NAEPP Guidelines are not related to barriers to access to care but may lie in patient lack of knowledge of or inability to follow an asthma management program. To my husband, Fredric, and my daughter, Kirsten April ACKNOWLEDGEMENTS To my advisor, Dr. Mathew J Reeves, my utmost thanks and appreciation for his support and guidance throughout this research project. I also thank my committee members, Dr. Michael P Collins and Dr. Michael D Brown for their constructive role in the writing of my thesis. I am grateful to Andrew Mullard for providing technical advice and to Jan Anderson at Spectrum Butterworth Hospital for the time she spent familiarizing me with the operational aspects of conducting a research study. The support of the staff of the Michigan Department of Community Health is gratefully acknowledged. Special thanks to Ann Rafferty and Sarah Lyon-Callo for their valuable critique of my defense presentation. Last but not least, my profound thanks to my husband, Fredric, for the opportunity to follow a dream and for his constant love, encouragement, and support throughout the last three years. TABLE OF CONTENTS LIST OF TABLES ................................................ . ......................................... vi LIST OF FIGURES ....................................................................................... viii CHAPTER 1 Introduction ........................................................................................... 1 Definition of asthma .............................................................................. 1 Clinical presentation of asthma ............................................................ 2 Classifying asthma severity .................................................................. 3 Pathophysiology of asthma .................................................................. 4 Growing asthma prevalence in the US. and Michigan ......................... 5 Utilization of health services for asthma ............................................... 8 Clinical practice guidelines ................................................................... 11 Guidelines for the diagnosis and management of asthma .................... 12 Systematic review of studies of children attending emergency departments for treatment of asthma .............................................. 19 Summary .............................................................................................. 26 CHAPTER 2 Study design ......................................................................................... 28 Study sites ............................................................................................ 29 Enrollment and eligibility criteria ......................... 30 Asthma care at the Butterworth Hospital Emergency Department ....... 31 Data collection ...................................................................................... 32 Defining asthma severity ...................................................................... 39 Measures based on recommendations from the NAEPP Guidelines ...42 Statistical analyses ............................................................................... 44 CHAPTER 3 Enrollment ............................................................................................ 6 Baseline characteristics of participants ................................................. 46 Recent history of asthma symptoms .................................................... 48 Classifying chronic severity .................................................................. 49 Usual asthma care severity .................................................................. 50 Emergency care history ........................................................................ 52 Asthma treatment ................................................................................. 55 Asthma management and control ......................................................... 59 Asthma awareness ............................................................................... 61 Clinical data .......................................................................................... 61 Two-week follow-up results .................................................................. 64 Summary measures of NAEPP recommendations ............................... 65 CHAPTER 4 Comparison of the Grand Rapids Children’s Asthma Cohort Study with similar reports in the literature .................................................. 70 Adherence to the NAEPP Guidelines: the gold standard? .................... 85 Limitations of the study ......................................................................... 88 Conclusions and future directions ........................................................ 90 BIBLIOGRAPHY ........................................................................................... 93 APPENDIX A-J Available from Dr. Mathew J Reeves Department of Epidemiology Michigan State University East Lansing, Michigan 48823 vi LIST OF TABLES TABLE 1 ........... The 1997 NAEPP classification of asthma severity ........... 3 TABLE 2 ........... Regional prevalence estimates from 1993—1995 (NHIS)...7 TABLE 3 ........... Michigan hospitalization rates by gender, 1990—1997 ....... 9 TABLE 4 ........... July 2002 NAEPP Guidelines updates on preferred long- term control medication ..................................................... 17 TABLE 5 ........... Review of ED studies ......................................................... 23 TABLE 6 ........... Classification of severity based on presenting signs and symptoms .......................................................................... 41 TABLE 7 ........... Predicted PEF values based on height .............................. 42 TABLE 8 ........... Baseline characteristics of children .................................... 47 TABLE 9 ........... Reported asthma symptoms before the ED visit ................ 48 TABLE 10 ......... Two methods of classifying chronic asthma severity ......... 49 TABLE 11 ......... Usual asthma care in the previous year.... ......................... 51 TABLE 12A ....... Emergency care in the past year ....................................... 53 TABLE 128 ....... Hospitalizations for asthma by chronic severity ................. 53 TABLE 120 ....... ED visits for asthma by chronic severity ............................ 54 TABLE 120 ....... Urgent care doctor visits for asthma by chronic severity....54 TABLE 13A ....... Reported medication use in 4-week period before ED visit .................................................................................... 55 TABLE 138 ....... Medication use in 4 weeks prior to ED visit by chronic asthma severity .................................................................. 57 TABLE 130 ....... Long-term control medication use pre-ED visit by chronic severity .............................................................................. 58 TABLE 14 ......... Asthma treatment: Use of systemic corticosteroids ........... 58 vii TABLE 15 ......... TABLE 16 ......... TABLE 17 ......... TABLE 18 ......... TABLE 19 ......... TABLE 20 ......... Asthma control and management ...................................... 60 Classification of acute asthma severity .............................. 62 Comparison of chronic and acute severity in children 27 years .................................................................................. 63 Comparison of chronic and acute severity in all children ...63 Follow-up appointments and post-ED visit urgent treatment visits at the 2-week interview ............................. 64 Comparison of measures of NAEPP recommendations with chronic asthma severity .............................................. 67 viii LIST OF FIGURES FIGURE 1 ......... Pathway to asthma ............................................................ 4 FIGURE 2 ......... Asthma emergency department visits, 2000 ...................... 10 FIGURE 3 ......... Contribution of individual symptoms to chronic severity construct ....................................................................... 50 Chapter 1 Introduction The burden of asthma in children in the US. and elsewhere has increased dramatically in the past two decades, whether measuwd by national health surveys or utilization rates of hospital services for treatment of asthma (Akinbami and Schoendorf 2002; Beasley 2002). Concern over n'sing asthma morbidity and mortality was the impetus for the formation of the National Asthma Education and Prevention Program (NAEPP) in 1989 by the United States National Heart, Lung, and Blood Institute (NHLBI) with the intention of improving asthma management through the establishment of national guidelines and recommendations for asthma care and treatment. While these guidelines have been available since 1981, there has been little focus on whether treatment and are provided to childmn with asthma is consistent with the NAEPP Guidelines. This thesis will examine the level of Woe to a number of key NAEPP recommendations regarding asthma (are and management in a cohort of children who visited a Michigan hospital ememncy department for the Natment of asthma. Definition ofasthma Asthma is a chronic disease affecting the lungs and the airways that deliver air to the lungs. Asthma is defined by mourring episodes of wheezing, coughing, shortness of breath, sensation of tightness in the chest, and reversible reduction in peak expiratory flow, as a result of acute or chronic inflammation of the airways. Decreases in forced expiratory volume during the first second of an exhalation (FEV1) or increased variability in peak expiratory flow (PEF) are indicative of asthma. Airway obstruction is considered reversible when the FEV1 improves by 20% or more after the inhalation of a bronchodilator (e.g., a short-acting BZ-agonist) (Beers and Berkow 1999). Although asthma can be controlled with medication and by avoiding asthma triggers, there is no known cure. Common asthma triggers include allergies (e.g., pet dander, dustmites, cockroaches, mold, pollen), dust, weather changes, exercise, and initants such as air pollution, cigarette smoke, and chemical and fuel vapors (Institute of Medicine 2000). Clinical presentation of asthma An individual presenting with asthma exhibits difficulty breathing. The patient assumes an upright posture when struggling for breath. Use of the accessory respiratory muscles is evident Wheezing can be heard throughout inspiration and expiration, which is sometimes accompanied by coarse rattling. The chest may appear hyperinflated or overexpanded. Rapid respiration and heart rate are present. In a severe attack, breathingwill besocompromisedthatthepatientmayonlybeabletosayafewwords at a time. Mental confusion, lethargy, and fatigue set in with severe respiratory distress. As the attack worsens, cyanosis can be observed. In progressive respiratory failure, less wheezing may be heard, owing to advanced mucous plugging and a marked decline in airflow and gas exchange. The severity of asthma can be assessed clinically by measuring the arterial blood gases. Even when patients seem asymptomatic between asthma attacks, they may still exhibit low to moderate wheezing. In persons with severe long-term asthma, physical changesinthechestwall,suchasa‘squaredoffthoraxabowingofthesternum,ora depressed diaphragm may occasionally be evident. Classifying asthma severity The 1997 NAEPP Guidelines provide a classification scheme for assessing asthma severity and advocate appropriate asthma treatment and management that corresponds with the patients level of severity (NAEPP 1997). Asthma is classified into four levels: mild intermittent, mild persistent, moderate persistent, and severe persistent asthma. Four criteria are used to categorize the asthma severity of patients: daytime symptoms, night-time symptoms, frequency by which exacerbations affect activities, and PEF or FEV1 measurements. Patients are classified according to the symptom with the highest level of severity (see Table 1). Table 1. The 1997 NAEPP classification of asthma severity Level of Daytime Night-time PEF or PEF severity symptoms symptoms FEV1 variability Mild intermittent 52/week $2lmonth 280% <20% (Exacerbations brief) Mild persistent 3—6/week 3-4lmonth 280% 20—30% (Exacerbations may affect activity) Moderate Daily 25/month >60— >30% persistent (Exacerbations <80% affect activity; 22 times lweek) Severe Continual Frequent 560% >30% persistent (Exacerbations frequent) Note: Clinical features before treatment. From (NAEPP 1997). Acute asthma, often called an exacerbation, is charaderized by a worsening of asthma with increased symptoms (as shown in Table 1) and mduced lung function. Although asthma symptoms can often progress over time to acute asthma, it is not uncommon for people with a history of intermittent asthma to develop severe asthma symptoms necessitating a visit to the emergency department. 3 Pathophysiology of asthma A longstanding theory suggests that people with asthma have hymrreactive airways that are more sensitive than normal to irritation (Pearce et al. 1998). An asthma attack occurs when the lining of the bronchial tube is irritated by an external trigger, becomes inflamed and, in response, bronchoconstriction occurs (Fig. 1). Trigger factor Airway inflammation / Airway muscle tightening Mucus Swollen production bronchial membranes \ Narrow breathing passages Wheezing, cough, shortness of breath Fig. 1. Pathway to asthma. Adapted from Protocare Corp. (1997). It is this bronchoconstriction, accompanied by mucus secretion and edema, which provokes the common symptoms of asthma: coughing, wheezing, labored breathing or dyspnea, and chest tightness (American Medical Association 2002). The underlying disease mechanism of asthma thus involves two components: bronchoconstriction and airway inflammation. Numerous immune cells, such as mast cells, eosinophils, neutrophils, macrophages, T lymphocytes, and cytokines and chemokines releawd by airway epithelial cells engage in complex interactions during 4 an inflammatory response. In chronic asthma, these interactions can lead to structural changes or remodeling of the lungs resulting in permanent changes in lung function (AMA 2002). To address the two underlying components of asthma, inflammation and bronchoconstriction, current asthma pharmacolherapy includes anti-inflammatory and bronchodilator medications (AMA 2002). Growing asthma prevalence in US and Michigan Prevalence of asthma in the US. among both adults and children ranks among the highest in the world (ISAAC 1998; Beasley 2002). Obtaining a valid estimate of the prevalence of asthma is difficult, owing to different methods of asthma ascertainment, changes in diagnosis, and methods of data collection (e.g., survey instruments) over time. One of the principal sources of asthma prevalence data for the United States has been the National Health Interview Survey (NHIS), a household survey of a representative sample of the noninstitutionalized civilian US. population (CDC 2000). Prior to 1997, information on asthma was obtained in the NHIS survey by asking, “During the past 12 months, did anyone in the family have asthma?" The self-reported 12-month prevalence of asthma in the US. in 1996 was 55/1000 people, an increase of almost 74% since 1980 (Mannino et al. 2002). In 1997, asthma prevalence questions in the NHIS survey were restricted to persons medically diagnosed with asthma and who had experienced an asthma attack in the last year. The resulting asthma attack prevalence was 40.7/1000 people. From 1997 to 1999, the number of episodes of asthma in the preceding year in fact dropped 5.6% (National Center for Health Statistics 2001; Mannino et al. 2002); however, it is not certain whether this is indicative of a true trend or a reflection of the change in the definition of asthma. The Behavioral Risk Factor Surveillance System (BRFSS), a national telephone survey in the US. of risk factors for chronic disease and health conditions in adults (218 years), has recently added questions about asthma prevalence to its core questionnaire. In 2000, the overall prevalence estimate for adult Americans with self-reported lifetime asthma (“Have you ever been told by a doctor that you have asthma?) was 10.5%; that of current asthma was 7.2% (‘Do you still have asthma?’), with much variation across states (CDC 2001). Lifetime asthma prevalence ranged from 8.0% in Louisiana and South Dakota to 13.4% in Nevada and 15.9% in Puerto Rico; the prevalence of current asthma ranged from a low of 5.0% in Louisiana to a high of 8.9% in Maine (CDC 2001). Lifetime asthma prevalence and current asthma prevalence in Michigan closely mirrored the national figures (10.3% and 7.3%, respectively). Based on NHIS data, prevalence of asthma among American children aged 5—14 years increased 74%, rising from an average of 42.8 per 1000 in 1980 to 74.4 per 1000 in 1993—1994 (NHLBI 1999). An even more dramatic increase over this time period was seen in children under the age of 5 years: 160% from 22.2 per 1000 to 57.8 per 1000. Apart from the self-reported BRFSS data, prevalence data do not exist at the state or county level. Weiss et al. estimated regional prevalence rates that were calculated from multi-year averages of asthma prevalence from the 1993-1995 National Health Interview Survey data sets (Weiss et al. 2000). People with asthma were defined as having asthma in the past year, and proxies were used for children under 19 years of age. Asthma prevalence estimates were then calculated for 42 combinations of age, gender, and race. Using county population estimates (by race, gender and age group) from the 1994 US. census, local asthma prevalence rates were computed and applied to the 42 demographic groups (Weiss et al. 2000). Because prevalence rates were derived from national demographic groups, these estimates may not reflect regional differences, e.g., asthma prevalence may be underestimated for counties with large low-income inner-city populations. Weiss’ prevalence estimates for the State of Michigan and Kent county are presented in Table 2. Table 2. Regional prevalence estimates from 1993-1995 (NHIS) Estimated prevalence Number of people Region (per 100 population) with asthma Michigan (all) 5.49 521,200 517 years 7. 36 185,400 218 years 4.81 335,900 Kent County Ell) 5.50 28,600 517 years 7.21 10,700 218 years 4.82 17,900 Note: From Weiss et al. (2000). See text re how data were calculated. In 2001 the Behavioral Risk Factor Survey in Michigan asked two questions about asthma in children inthehousehold, “Earlier you saidtherewere_childrenage 17 or younger living in your household. How many of these children have ever been diagnosed with asthma?” The prevalence estimate of children in Michigan ever diagnosed with asthma was 12.2:1.8%, and of children who still have asthma, 8.31:1 .4% (S. Bohm, MDCH, Nov 15, 2002). Utilization of health services for asthma Hospitalizations for asthma Measures of asthma morbidity include self-reported prevalence (as previously discussed), hospitalizations and emergency department visits for asthma attacks, and physician office visits. The estimated annual rate of hospitalizations for asthma in the US. peaked in 1985 (19.7/10,000 population) and has since ban on the decline (Mannino et al. 2002). Data from the 2000 National Hospital Ambulatory Medical Care Survey give a hospitalization rate for asthma of 17/10,000 (NCHS 2003). From Michigan hospital inpatient discharge data for the period 1992-1993, asthma accounted for 9.4% of all hospitalizations in children under the age of 15 years, and 13.3% of all hospitalizations in children aged 5—9 years. (Vchox and Hogan 1996) For Kent County, the annualized hospitalization rate for children during 1989—1993 was 214710000, which is much lower than the overall state rate of 34.3/10,000. By comparison, southeastern Michigan (counties Wayne, Washtenaw, Jackson and Lename) had the highest hospitalization rate of 53.1/10,000 (Wilcox and Hogan 1996). This may be explained by the fact that these counties have a higher proportion of minorities than Kent County. From 1989 to 1993, the annualized hospitalization rate for black children in Michigan was 3.2 times higher than that for white chum (blacks, 81.3/10,000 vs. whites, 25.6/10,000) (VWcox and Hogan 1996). More recent data regarding hospitalization rates for asthma by gender, given in Table 3, show that Kent and Ottawa County rates for both genders remain below those for Michigan. Table 3. Michigan hospitalization rates by gender, 1 990—1 997 Hospitalized for Asthma (1990—1997) per 10,000 children Region ages 1—14 Males Females Michigan 38 22 Kent County 27 14 Ottawa County 15 9 Note: Data from Primary Health Care Profile of Michigan (Michigan Primary Care Association 2002). ED visits for asthma Asthma is one of the most common reasons for pediatric patients to visit an emergency department (Dawod et al. 1996; Zimmerman et al. 1998). In the US, the number of emergency department (ED) visits for asthma from 1992 to 1999 (data collected by the National Hospital Ambulatory Medical Care Survey) increased 36% (Mannino et al. 2002). The annual rate for ED visits rose 29%, from 56.8 in 1992 to 73.3 per 10,000 people in 1999. Over this same period, females had consistently higher rates than males. Among children, those aged 0—4 years had the highest rate of ED visits: 1418110000 in 1999. Blacks had substantially higher rates than whites (1999 figures: 174.3 vs. 59.4 per 10,000, respectively) (Mannino et al. 2002). Data recently released from the 2000 National Hospital Ambulatory Medical Care Survey show the rate of ED visits for asthma as 67I10,000 population, a Wine of 8.6% from 1999 (NCHS 2003) (Fig. 2). In 2000, childmn under 18 had an ED visit rate of 104/10,000. ED visit rates for children 0-4 years were high at 180/10,000. Although that for blacks was 125% higher than whites, the ED visit rate had dropped to 133/10,000 from 1999. The rate for whites remained unchanged, and that for women was almost 30% higher than for males (NCHS 2003). Applying the 2000 national ED visit figue for children under 18 to be combined 2001 population estimates for Kent and Ottawa counties gives an annual estimate of approximately 2400 ED visits for asthma. Asthma Emergency Department Visits, 2000 140 133 12c 100 80 T rats-.3452 at 60 ~ ? . . rig _-. .: [sauna-n, -=:s" " ,...~t.<. 40 - , - var-es: 20 . l'i-I'I'.'.':'.':'I‘ . . , . .555 «Ne. .......... .......... ................... ........ ......... '''''''''''''''' .......... .'... ....... Per10,000 popuatron .3 z. -' '=- ~~=¢ -. _:-:;.:::; ~' . ,3 :;: . Total 0-17 218 White“ Black* Male" Female" years years *Adjusted to 2000 population Fig. 2. Asthma emergency department visits, 2000 (NCHS 2003). The recant decline in some hospitalization and ED visit rates may be an indication that some progress towards reducing the health burden of asthma is being realized, perhaps stemming from the integration of the asthma care NAEPP guidelines of the National Health Lung and Blood Institute into asthma education interventions and asthma management plans designed for patients (Mannino et al.2002). Office and outpatient visits for asthma Another indicator of the health burden of asthma is the number of physician office and hospital outpatient visits. Data on physician office visits were collected through the National Ambulatory Medical Care Survey from approximately 2000 participating physicians. The National Hospital Ambulatory Medical Care Survey was the source for data on hospital outpatient visits; this survey samples roughly 500 hospitals amually. 10 From 1980 to 1999 in the US, the number of physician office visits for asthma increased from 5.9 to 10.8 million. It should be noted that from 1992 to 1999, hospital outpatient visits (approximately 1 million annually) were included with physician office visits (Mannino et al. 2002). ‘Ihe 2000 National Hospital Ambulatory Medical Care Survey reported 10.4 million outpatient visits for asthma were made to private physicians offices and hospital clinics (379/10,000); children aged 0—17 had 4.6 million visits (649/10,000) (NCHS 2003). Asthma was the primary reason for 9.3 million office- based physician visits in 2000 (Cheny and Woodwell 2002). Clinical practice guidelines Clinical practice guidelines are developed, primarily by health organizations, to assist practitioners and clinicians in making clinical decisions (Homer 1997). Ideally, guidelines provide useful advice on a range of topics, such as evaluating medical conditions, assessing risk, or proposing appropriate health interventions and follow-up care. By defining current best practice and providing up-to-date treatment information, clinical guidelines are intended to reduce inappropriate health care, costs, and malpractice suits, while optimizing health outcomes (Woolf 1993). A ‘mechanism of action,’ proposed by Woolf (1993), describes in stepwise fashion the process through which guidelines become adopted into practical use. Guidelines that are effectively assimilated into practice, first, must improve knowledge by increasing physicians’ awareness of the recommendations; second, must gain agreement and acceptance in the medical community; third, must be implemented by changing physicians’ practice 11 behavior to be in line with the recommendations; and fourth, must improve health- and (or) cost-related outcomes (Woolf 1993). There has been, however, little direct evidence that practice guidelines actually improve clinical outcomes in primary care or change physician behavior (Lomas et al. 1989; Worrall et al. 1997; Cabana et al. 1999). Criticism of guidelines has often centered on the validity of the underpinning evidence for the recommendations. The basis for recommendations in the past has ranged from strong evidence coming from rigorous randomized clinical trials to weak evidence from observational studies or from expert opinion in absence of any real data (Wilson et al. 1995; Worrall et al. 1997). Development of guidelines has evolved from reliance on consensus and expert opinion toward evidence-based data, as these studies have become available (Hayward et al. 1995; VVIlson et al. 1995; Worrall et al. 1997). Thus, implementation of the more recent evidence-based guidelines may in fact lead to improved patient outcomes (Worrall et al. 1997). Guidelines for the Diagnosis and Management of Asthma The 1991 Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma was published by the NAEPP to provide information on the diagnosis and management of asthma backed by scientific research available at the time. The 1991 Guidelines comprised four components of asthma management: measures of assessment and monitoring, control of factors that contribute to asthma severity, pharmacologic therapy, and education in asthma care for both health professionals and patients. Six years later the Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma was issued to provide 12 an update to the 1991 recommendations. Updates included expansion of the role of inflammation in asthma, changes in the classification of asthma severity, and changes in recommendations for monitoring and pharmacologic treatment of asthma based on firmer scientific evidence. One of the most notable improvements of the 1997 Guidelines over mose issued in 1991 has been the increased scientific base of asthma research for the recommendations (NAEPP 1997). As primary care physicians see about three-quarters of all asthma visits by childmn, the promotion of the NAEPP Guidelines was directed at the primary care community (Fried 1998; Grant et al. 1999). Two studies examined the adherence of primary care physicians to components of the NAEPP Guidelines (Grant et al. 1999; F inkelstein et al. 2000). In 1998 the F inkelstein study surveyed 671 primary care pediatricians and family physicians, who practiwd in three managed care organizations located in Chicago, Seattle, and Boston. The cross-sectional study by Grant et al. mailed questionnaires to 405 Chicagoarea physicians identified by the American Medical Association database. The Grant study was conducted in 1997 and overlaps with the issuance of the 1997 Guidelines (Grant et al. 1999). Awareness of the NAEPP Guidelines was high: 88.5— 91% of physicians in both surveys had heard of the Guidelines and 72-73.6% had read them. Although physicians demonstrated awareness of the recommendations, there were still gaps in the physicians’ promotion of self-management practices, e.g., providing written asthma treatment plans ranged from 47.7 to 50%. Only 23.6% of physicians in the Grant survey reported that they referred patients to formal asthma education, although all physicians indicated that they provided some form of patient education. 13 Failure to integrate the Guidelines into practice does not appear to be due to lack of awareness. However, reasons cited for noncompliance by physicians include barriers in adopting the practices (lack of time, recommendations not convenient to use), disagmement with the Guidelines, and belief that the recommendations are too rigid for patients (Hayward et al. 1997; Picken et al. 1998; Cabana et al. 1999). Lack of educational materials, support staff, and reimbursement were cited as additional reasons for physician noncompliance with the asthma mcommendations in another national survey of 829 physicians (Cabana et al. 2001). The NAEPP Guidelines set out six goals for maintaining control of asthma for adults and children older than 5 years of age: (1) prevent chronic and troublesome symptoms, such as coughing or breathlessness in the night, in the early morning, or after exertion, (2) maintain (near) normal pulmonary function, (3) maintain normal activity levels (including exercise and other physical activities), (4) prevent mourrent exacerbations of asthma and minimize the need for emergency department visits or hospitalizations, (5) provide optimal pharmacotherapy with minimal or no adverse effects, and (6) meet patients’ and families” expectations of and satisfaction with asthma care (NAEPP 1997). Several NAEPP recommendations for the care and home management of asthma are aimed at achieving these goals: (1) regularly scheduled appointments with asthma care providers, (2) self-monitoring of peak expiratory flow (PEF), (3) appropriate pharmacologic therapy, (4) written asthma management and action plan, (5) asthma education, (6) referral to an asthma specialist when asthma is difficult to oontnol, and (7) follow-up visits with a primary care doctor within 5 days after a visit to the emergency department for asthma. 14 (1)Scheduled 'ntmentswiththe ‘ s ularasthmacare vider The guidelines recommend regularly scheduled visits to the regular asthma care provider (RACP) at 1- to 6—month intervals to ensure that the patient’s asthma is under control (NAEPP 1997). The RACP is defined as the health professional responsible for writing the patient’s prescriptions; developing the asthma management and action plans; providing counseling, on-going treatment, and asthma education; and monitoring the disease. Patients with mild intermittent and mild persistent asthma that has Mn under control for at least 3 months should be seen by their RACP every 6 months. Those with persistent asthma are advised to have asthma check-ups more frequently. As part of a routine asthma checkup, the RACP assesses a patient’s asthma, reviews the patient’s asthma self-management and action plan, and asks about difficulties the patient may be encountering with respect to peak flow monitoring, inhaler technique, or drug side effects (NAEPP 1997). (2) Peak expiratmr flow monitorigg Peak expiratory flow (PEF) monitoring is a recommended practice for those with moderate to severe asthma. A fundamental part of a patients asthma self-management toolkit, PEF monitoring measures the existence and severity of an airway obstruction. Patients must first establish a personal best value, which is the highest peak expiratory flow rate (PEFR) recorded, by taking measurements twice daily over a 2- to 3% period (Stritch School of Medicine 2002). The personal best PEF differs from the predicted value, which is an average PEFR value based on gender, age, and height (Stritch School of Medicine 2002). A patient’s PEF readings may be higher or lower than their predicted value. By observing trends in PEF readings, adjustments can be 15 made to the patient’s treatment plan to return the readings to the personal best value (Stritch School of Medicine 2002). Generally, children over the age of 5 are capable of using a peak flow meter with proper training. For all persons with asthma, taking peak flow readings during an exacerbation can assist in controlling the symptoms, however, because of noncompliance concerns, the Guidelines do not recommend lggg-term peak flow monitoring for patients with mild intermittent or mild persistent asthma. (3) Pharmacotheragy The 1997 Guidelines also address the assignment of appropriate medications to control each level of severity. For adults and children of all ages, no long-term control medication is mcommended for mild intermittent asthma. For mild persistent asthma, daily anti-inflammatory medication is recommended for long-tenn control in the form of an inhaled low dose steroid, or cromolyn or nedocromil for children older than 5 years. Medications for long—term control of moderate persistent asthma include either a medium dose of inhaled corticosteroid or a low to medium dose of inhaled corticosteroid plus, if needed, a long-acting bronchodilator (B—agonist, theophylline, or Ieukotriene modifier). For severe asthma, a high dose inhaled corticosteroid plus a long—acting [3— agonist (LABA) is the preferred treatment A stepwise approach to pharmacotherapy is endorsed by the NAEPP: therapy should commence at a level higher than the patients current stage of severity to gain control swiftly and then treatment may be stepped down to the point at which the minimum dose of medication is sufficient to maintain control. Treating asthma more aggressively initially brings about more rapid suppression of airway inflammation. The stepwise approach coincides with the four 16 severity levels: step 1, mild intermittent asthma; step 2, mild persistent; step 3, moderate persistent; and step 4, severe persistent AnupdateoftheGuide/inesissuedinJuly2002focusedontheimportanceof inhaled corticosteroids in controlling asthma (NAEPP 2002). Inhaled corticosteroids as a first-line therapy for children as well as for adults with persistent asthma is now an NAEPP recommendation backed by strong evidence from nine randomized trials. The preferred treatment for moderate persistent asthma for adults and children over 5 years of age was revised to include LABA as adjunct therapy with low to medium dose inhaled corticosteroids. The update included specific treatment modifications at each step. The preferred long-term control treatments are as shown in the table below, quick relief nedications can be used as needed by all patients. Table 4. July 2002 NAEPP Guideline updates on preferred long-term control medications ' Level of severity Daily medications recommended Step 4 High-dose inhaled corticosteroids Severe persistent And Long-acting inhaled B-agonists And, if needed, Corticosteroid tablets or syrup (systemic) Step 3 Low- to medium—dose inhaled Moderate corticosteroids persistent M! Longjcting inhaled B-agonists Step 2 Low-dose inhaled corticosteroids Mild persistent Step 1 No daily medication needed. Systemic Mild intermittent corticosteroids are recommended when severe exacerbations occur 17 (4) Asthma maLaggment plan To control and adequately manage asthma, a patient must admre to a multifaceted asthma management program, developed with the RACP. An asthma management plan covers appropriate use of medication tailored to file patients level of severity, regular checkups, prevention by avoiding or controlling known asthma triggers, and an asthma action plan (Leickly et al. 1998). The asthma management plan also includes personal goals the patient wishes to attain, such as being able to manage their symptoms to the point that they can, for example, play sports without succumbing to an asthma attack WienapafieitexpenemesaiasflinaemcerbafionJheindvidJahasbst oontrolofhisllrterasthma, sigialingtl'teneedtoreviewaldatjrsttheasthmamalagemerlt program. An individualized asthma action plan informs the patient what steps to follow when their asthma worsens (NAEPP 1997). These instructions advise the patient to adjust their asthma medications in response to signs and symptoms they are experiencing and to meir peak flow measurements. An action plan also lists local acute care and emergency telephone numbers, and any other special instructions to assist a patient during an exacerbation. (5) Asthma education The NAEPP Guidelines recommend that at or shortly after the time of diagnosis, the primary health care provider should provide essential asthma education, including basic information about the disease and what happens to the airways during an exacerbation; how long-term and quick relief medications work and the differences betwwn them; techniques for using asthma equipment such as inhalers, spacers, and peak flow 18 meters; identifying environmental asthma triggers and how to avoid them; and how to recognize worsening asthma symptoms and the appropriate actions to take (NAEPP 1997). These educational messages need to be reviewed periodically with the patient. (6) Consultation with an asthma m'alist Seeing an asthma specialist, usually an allergist or a pulmonologist, is recommended for patients who encounter difficulties in controlling their asthma. This recommendation is based on the opinion of the NAEPP Expert Panel, in absence of evidence-based data. If the patient has had a life-threatening exacerbation or requires intense treatment for moderate to severe persistent asthma (step 3 and 4 care), if there are comorbidities or allergy problems that complicate the treatment of asthma, or if the patient is on a continuous regimen of oral or high-dosed inhaled corticosteroids, a consultation with an asthma specialist may provide additional therapies, education, or insight in dealing with an environmental exposure. (7) Follow-up amintment after an ED visit After an exacerbation that requires hospitalization or an emergency department visit, the Guidelines advocate a follow-up medical appointment with the RACP within 5 days after discharge to establish or resume regular asthma care and to review the patients medications, asthma action plan, and techniques in using their asthma equipment. Systematic review of studies of children attending emergency departments for treatment of asthma Energemydepamerts(EDs)novideauiqeoppatfltytocdbdasfinadatadiecfly fiunpafimts.anamssfirdiesusingMedicddamaagedcaedatabaseshavebem condrdedmaspedsofpfimayasfinacaemdmaagemerthealhcaeufilizafimmd 19 ontheheallhinsuaroerecords. Disadvartagesofstudiesbasedonchatwslraclionfrom hedflrinsranecmpatiesinchdeexdusimddiildarwiflmheamrsuaneje firdailtybdimdlyassessdmflcasfinasevefilybasedmfiemarwdsynmnsaby pea<flowmeasuemarts(aspertheNAEPP), andladtofinformation regatingactudor unatteedasflvnanedicafiaeardasfinaequmatwdraspedflmmetasfiamu atdOberklaid1991; Flrkelsteineta.2011),Apteretal.2001;Shieldsetal.2002). lrrterviews with patients in emergency depatments car provide more comprehensive information on syn'ptonsddrmicuualyingseventychmpafiartsmaageteirdiseasehtansof nmibrhgsynptomsmdlaldngncdlcafimaumasmmaednamreyhaw received. A literature search for aticles assessing primay asthma care and management of ED pediatric patients and comparison with the NAEPP recommendations was conducted using Medline. Keywords “National Asthma Education and Prevention Program, NAEPP guidelines, National Heat, Lung, and Blood Institute (NHLBI) guidelines, children, asthma, emergency” yielded a total of 125 articles from 1991 to January 1, 2003. Nine articleswereselectedtl'latfitthecriteriaofcohortorcross- sectional surveys of ED visits by children for asthma treatment, and that collected data on any of seven key measures of asthma care ard management from the NAEPP recommendations (as previously listed). Bibliographies of studies comparing patient asthma care and management characteristics with the NAEPP Guidelines were also checked for additional references. Al’drough three of the nine reviewed articles made no mention of the Guidelines, their data contained measures that could be compared with 20 the seven recommendations (Butz et al. 1991; Friday et al. 1997; Ferris et al. 2001). Three articles cited the NAEPP recommendations (Davidson et al. 1994; Farber et al. 1998; Stevens and Gorelick 2001) and three papers made direct comparison of several measures with the Guidelines (Crain et al. 1998; Dinkevich et al. 1998; Scarfone et al. 2001). Emergency department use for asthma care has been associated with younger children, lower income, living in an urban center, minority status, and poorer health (Halfon and Newacheck 1993; Halfon et al. 1996; Hanania et al. 1997; Zimmerman et al. 1998; Woodward et al. 1988). Six of the nine ED studies took place at inner city hospitals (Butz et al. 1991; Friday at al. 1997; Dinkevich et al. 1997; Faber et al. 1998; Crain et al. 1998; Stevens and Gorelick 2001). Inner cities have been shown to have higher proportions of asthma and non—Caucasian populations who are more likely to receive episodic rather than continuous medical care aid to mceive that care in emergency departments (Weiss et al. 1992; Halfon and Newacheck 1993; Crain et al. 1994; Halfon et al. 1996). The remaining studies were carried out in urban hospitals (Davidson et al. 1994; Fenis et al. 2001; Scarfone et al. 2001). Two surveys enrolled patients aged 18 and under (Friday at al. 1997; Dinkevich et al. 1998), while the other studies restricted eligibility to children aged 2—17 years (Davidson et al. 1994; Ferris et al. 2001), 2—18 years (Scarfone et al. 2001; Stevens and Gorelick 2001), 7—12 years (Butz et al. 1991), 4—9 years (Crain et al. 1998), and 2-6 years (Faber et al. 1998). In five studies, children with Medicaid health coverage constituted 50% or more of the study population (Davidson et al. 1994; Crain et al. 1998; Dinkevich et al. 1998; 21 Scarfone et al. 2001; Stevens and Gorelick 2001). See Table 5 for study design and patient demographics. Eligibility for participation in the studies was based on a case definition of asthma that ranged from presentation with wheezing symptoms (Friday at al. 1997; Dinkevich et al. 1998), presentation of acute asthma symptoms (Butz et al. 1991; Davidson et al. 1994; Fenis et al. 2001), to a previous physician diagnosis of asthma, history of asthma, and use of bronchodilators (Farber et al. 1998; Stevens and Gorelick 2001). The NAEPP reclassified asthma severity in the 1997 Guidelines from mild, moderate, and severe, as given in the 1991 Guidelines, to mild intermittent, and mild, moderate, and severe persistent. Severity of asthma was documented in only four studies (Crain et al. 1998; Dinkevich et al. 1998; Farber et al. 1998; Scarfone et al. 2001). Assessment of asthma severity differed among the four studies. Scarfone reported that 64% had persistent chronic asthma interpreting the NAEPP Guidelines on severity (based on frequency of day- and night-time symptoms), while 72% in the Farber study had moderate to severe asthma. The Farber study used the Asthma Functional Severity Scale to determine severity. Briefly, this measurement of severity is based on frequency and intensity of asthma episodes, and the frequency of symptoms and intensity of impairment between episodes over fire previous year (Rosier et al. 1994). Two categories of severity were reported in the Dinkevich study: 54.6% were calculated to have had fewer than four attacks in the past year and 44.8% had four or moreattacks. Childenwithmorethanfouattaclealsoreportedworsefmctional morbidity (measued byfreqaencyofday—a'rdniglt-timecwgrardofnigrtsofpoorsleep) (Dinkevidr et al. 1998). The NAEPP classification of asthma severity is symptom based, 22 xoaam map: came ow con :09: 9:500 Bow << 38 <5. *3 2m 0.5%.... .xfimlmv ococ axe: 9.0.50 0853 .6230 men. << $8.13 <5. $5 .0069: :35 w: Elm m50< vm: room ..m .0 mEmn. accesses , 09:00 .0 9.03 cm 0.5%.... $8 ococ m... 0.8 meE «N .o mooE .625 << as: <5. as: mm w mom. w: 9 ml... 9:53 NM mum... mama .0 .0 50.0 mm. c. x .. >025 om. pen 3.0 Locc. ...oocococn. mama << $09 <2 <.. .9525 302 wlm .mEc.m< we .0 .0 .090“. .635 0.5%.... $5 0:0: $59 am. 3.0 .09.. mama << exemdm <5. cams >2 .565 w v offices; mmm .0 “0 20.29.50 >023 00.5. 0:0: $93 cm. 3.0 .09... £00.. 39 << seam <5. $53 00...“. 9.0: can .4023 cases... *2 .52. am Be :25 messes 32 << $vm 20060.2 scum _m. 00:332.“. film mEEm< at. ..m .o 502.60 am tocoo A<<. cmotoE< 050.com 5.0 .05.. 05500 9.82.005 50:? scum <2 05. .0.oE...mm Nels 050< mm? 59 ..m .0 53 5.0.5.3 .000”. 00:05»... 35 Bee» flm< Emma 0000 = mean ...053< cease am a 323m ..c. 2%.. 23 whereas many studies categorize severity on criteria such as frequency of use of health services for urgent treatment. In the Grain study, 50% of the patients were intentionally selected with severe asthma, based on reporting the following criteria in the previous year. used two or more asthma medications simultaneously, or were hospitalized, or had had two or more ED visits. Access to primary care providers (PCPs) was generally high. In six articles that reported this information, over 90% of the patients had a PCP (Davidson et al. 1994; Crain et al. 1998; Dinkevich et al. 1998; Ferris et al. 2001; Scarfone et al. 2001; Stevens and Gorelick 2001). In the aticle by Ferris et al., 79% of me uninsured had a PCP; but of those children with healfl'r insurance 90—97% had a PCP. The proportion of children in these studies who had asthma action plans ranged fiom 20 to 59.3%, indicating that having a primary care provider did not necessarily coincide with receiving recommended asthma care and self-management advice (Crain et al. 1998; Dinkevich et al. 1998). Little information was available as to the content of the plans, alflrough one study mentioned that the asthma management plan consisted of only the instructions “Go to the ED” if asthma was worsening (Davidson et al. 1994). The studies did not articulate what proportion of those with action plans followed the steps as their asthma worsened leading up to the ED visit Of those articles that collected data on PEF meters, the proportion of children with PEF meters ranged from 13.7 to 45% (Grain et al. 1998; Dinkevich et al. 1998; Scarfone et al. 2001). Determining the use of inhaled corticosteroids among the nine studies was difl‘icult, as the information about inhaled corticosteroid use was often presented in combination with otter long-tenn control medications or stratified by subgroup of patients. In addition, asthma treatment 24 regimenschangeovertime,ardthismayhavebeenafactorinthetypesof medications used ard the proportion of use, as the studies were conducted over a range of about 10 years. In Scarfone’s cross-sectional survey, 17% of the children reported they were using ICS prior to the ED visit compared with 23% in the prospective study by Friday at al. (1997). Children interviewed in the study conducted by Farber managed their asthma primarily with albuterol (91%); only one patient used ICS (it is not known when the data were collected). The remaining studies did not report ICS use as a separate item or as a proportion of the entire study population; some stratified ICS use by health insumnce coverageorbywhetherthe patients had a regularasthma care physician. Tmnty—seven mrcent of subjects used cromolyn, steroids, or theophylline in the study by Davidson et al. (1994); 39% of children with a RACP versus 16% with no RACP used ICS (Dinkevich et al. 1998); Ferris recorded ICS use that ranged from 13— 21% by health insurance status (Fenis et al 2001); Crain’s survey showed 27.1% of patients used a combination of ICS and cromolyn in the 3-month period prior to the ED visit (Crain et al. 1998); and in Stevens’ paper, 5% used only ICS, 46% stated they used a combination of cromolyn, ICS, and albuterol, and 9% took cromolyn and ICS (Stevens and Gorelick 2001). Two studies had data on patient visits to an asthma specialist in the past year, fewer than 7% of patients saw an allergist or pulmonologist, despite the facts that atopy is a strong predisposing factor for wheezing in children (Friday at al. 1997; Scarfone et al. 2001), and that in the studies for which severity of patients’ asthma is known, the majority had moderate to severe asthma. Follow-up visits with primary asthma care doctors alter an ED visit were mported by only two studies. These visits fell within 2—8 25 weeks of the ED visit, Which is outside of the 5—day NAEPP recommendation (Butz et al. 1991; Stevens and Gorelick 2001). Summary Thereisascarcityoflfleraturedowmenfingflreadherenceofasflrmacareand management criteria to the Guidelines among children who use the emergency department for urgent asthma treatment. Indeed, of the nine papers that did have reportable measures of NEAPP recommendations, each paper addressed on average 2.2 measures of the 7 listed in this thesis (range 1-5) (T able 5). The NAEPP Guidelines for the Diagnosis and Management of Asthma have been in effect since 1991. Although they should be well integrated into clinical practice and asthma education programs, studies have shown that aspects of patient asthma care and management frequently fall short of the recommendations. From an inception cohort of clinical subjects at an urban Michigan hospital emergency department, patients’ history of asthma care, education, management, preparedness for asthma exacerbations, and urgent visit follow-up compliance should reflect in part the degree to which the NAEPP Guidelines are being incorporated into patients’ routine asthma management. Specific aims of this thesis will include the following: A Describe the demgggmic characteristics of children with asthma who seek treatment at an urban Michigan hospital emergency department 8. Determine the mggjfion of chilan whose asthma care and management Ms witl_r_t_he fo_l|owirg seven recommendations of the NAEPP: 1. Had 22 regularly scheduled asthma checkups in the past year 26 2. Have a PEF meter and use it 3. Take inhaled corticosteroids for moderate to severe asthma 4. Have an asthma action plan 5. Received asthma education 6. Saw an asthma specialist in the past year for those patients with moderate to severe asthma 7. Had a follow-up visit (alter emergency department visit) with regular asthma care doctor by the 2-week follow-up interview C. Describe chronic and acute asthmg severity among this cohort of children by (i) categorizing underlying (_ch_roLic) severity in the 4—week period preceding the ED visit along me cutpoints of the NAEPP Guidelines for asthma severity; and (ii) categorizing §_cut_e severity at the ED using peak flow rates (drildren age 7+) as per the NAEPP and using signs and symptoms upon presentation for children <7 years. Examining the children’s routine asthma care and management prior to the ED visit will (i) provide a baseline characterization of asthma pediatric patients who use the ED for urgent care; (ii) provide insight into how well information from the Guidelines has been disseminated and incorporated into regular practice by these patients and their families in Michigan; (iii) be useful in preparing possible educational programs or clinical interventions should gaps in asthma care and self-management become evident; and (iv) help to identify areas for research into improving patient care and treatment. 27 Chapter 2 Study design Emergency medicine research often makes use of single cohort or case series designs to study injury patterns, identify predictors of health outcomes, or to gather information for prevention programs (Panacek 2000). Mehta et al. used a prospective case series to investigate why patients sought ED Watment for sexually transmitted diseases (STD) when an STD clinic was situated across the street from the hospital (Whta et al. 2000). A case report on ketamine abusers at the ED identified symptoms related to ketamine abuse (Weiner et al. 2000). This investigation was originally designed as a prospective cohort study of childmn with asthma wifir the following objectives: (i) to describe the characteristics of children who prewnt at emergency departments for acute asthma; (ii) to identify where gaps existed in primary asthma care and self-management measures; (iii) to document what factors may predispose ED use; and (iv) to document asthma-related outcomes 2 weeks and 6 months after the index ED visit. Thme Michigan hospitals participated in the study: one urban, one suburban, and one rural. A wntral obpctive of the study was to describe how the measures listed above differed across the hospitals from three different locations. Owing to low recruitment at two of the three hospitals, however, the comparison across the three hospitals was not possible. Only the urban site (Spectrum Butterworth) had completed enrollment of its child cohort study by September 2002. This thesis will therefore present findings from the 139 enrolled patients at this single site. 28 Sample size For the original study design, a total sample size (n) of 385 participants had been estimated, or 129 per hospital, to conduct a descriptive study analysis, using an expected (worst case) prevalence (p) of 50%, a precision (a) of 15%, and a 95% confidence interval. The function, 22%, denotes the percentile of interest of a standard normal distribution (Rosner 1995). The equation for calculating sample size for a population proportion is given below. The table shows several calculations based on a range of probabilities fiom 0.4 to 0.7. "=221-a/2 (1-p)/£2p p n 0.4 577 0.5 385 0.6 257 0.7 165 Study sites Four acute care hospitals serve Grand Rapids, Michigan, and sUrrounding counties, primarily Kent and Ottawa, which have a combined population of 813,000. Spectrum Butterworth Hospital, located in downtown Grand Rapids, and Spectrum Blodgett Memorial Medical Center, situated in suburban Grand Rapids were selected as two study sites. Jointly the two medical facilities have 1044 beds and annually attend to 47,000 admissions and 130,000 emergency visits (Spectrum Health 2002). The third study site was Gerber Memorial Hospital, a rural community hospital with 73 beds, located in Fremont, Michigan, in the county of Newaygo, which has a population of 48,000 (US Census 2002; Gerber Memorial Health Services 2002). Fremont is situated about 40 miles northwest of Grand Rapids, MI. 29 Enrollment and eligibility criteria Patient enrollment began in September 2001 and continued until participalt numbers were obtained. Enrollment was limited to patients 2—17yeas of age. Interviews with parents/guardians of pediatric patients were conducted in the emergency depatrnent by hospital staff trained in the study protocol. Inclusion criten'a Potential paticipants were identified in two ways: (i) by interviewers who personally monitored the emergency triage ama for patients with a chief complaint consistent with an asthma exacerbation, or (ii) by emergency personnel who notified off-site interviewers when patients presented at emergency with signs and symptoms consistent with an asthma exacerbation. (Interviewers were considemd to be ofi-site when they were at their respective oflices, which were housed in an adjacent hospital building.) To be eligible for the study, patients had to have signs and symptoms consistent with an asthma exacerbation (i.e., wheezing, shortness of breath, chest tightness, or cough) _a_ng have a final ED diagnosis of asthma _o_r any one of the following: a previous physician diagnosis of asthma (ever) or reactive airway disease (ever) or a history of bronchodilator medication use (excluding over the counter medication) in the last year (see Screening Criteria Appendix A & B). Exclusion criteria Patients were excluded if fl'rey met one or more of the following criteria: 0 Life-threatening respiratory distress 30 o Other significant illnesses such as any major chronic disease or disability, including HN/AIDS, immunodeficiency, cystic fibrosis, bronchopulmonary dysplasia, or other chronic cardiopulmonary disease 0 Cognitive impairment on the part of the parent such that their ability to follow medical advice would be significantly impaimd o No fixed address or not available for follow-up . Unable to communicate in English or Spanish 0 Already participating in another intervention study or asthma study Asthma care in the Butterworth Hospital Emergency Department Typically patients seeking treatment at the ED approached the triage nurse in the emergency department Patients were then seen by an attending physician and examined. It a determination of either asthma symptoms or an asthma exacerbation was made, an on-site respiratory therapist if available performed an initial lung function assessment using pulse oximetry (PaOz), and in children 27 years of age, took peak expiratory flow (PEF) measurements. If required, treatment with a short-acting bronchodilator (albuterol) was begun immediately to forestall further deterioration. Once treatment was undenrvay, the patients history was taken and a physical examination was made noting the signs and symptoms of the exacerbation. A patient may exhibit several, but not necessarily all, signs and symptoms typical of an asthma exawrbation (breathlessness, affected speech, wheezing, labored breathing, and coughing), which will determine the severity classification of the exacerbation. A respiratory therapist or ED nurse monitored the patients approximately every 20 minutes afler administration of albuterol in the first hour, oxygen saturation and PEF 31 were measured for an indication that the exacerbation was abating. For moderate and severe exacerbations, if patient response to albuterol was not immediate, oral or intravenous systemic corticosteroids were administered. Supplemental oxygen was given if patients had significant hypoxemia. If a good response was seen after treatment, i.e., PEF 270%, and the patient was stable and no longer in distress, then the patient was discharged. The physician would use clinical judgement to determine if hospitalization was necessary when the patient showed an incomplete response to treatment, for example, if PEF 250 but <70%. Patients with a PEF <50% after treatment were generally admitted to the hospital. In infants, an oxygen saturation of <91% on room air was generally considered an indication for hospitalization. While the patient waited for medication to take effect, and if time permitted, the respiratory therapist or nurse reviewed with the patient and family what to do during an exacerbation, and provided patients with educational materials about asthma triggers and instruction on how to use asthma equipment, such as a peak flow meter and a metered dose inhaler with spacer. Discharge instructions were given to the patients parent and a copy was sent to the primary care doctor. Asthma patients at discharge were typically prescribed a short course of oral steroids (5 days). The patients were advised to make a follow-up appointment with their primary asthma care doctor as soon after the ED visit as possible to review their medications and asthma management plan. Data collection lnfonnation on demographics, usual asthma care and management practices and utilization of health services in the past year, asthma severity, and post ED visit asthma- 32 related outcomes was collected from pediatric patients attending emergency departments at the three aforementioned hospitals for treatment of their asthma. Funding permitted the staffing of one study coordinator, who was located at the Butterworth campus and was assisted by a research nurse and medical student, to implerrrent and conduct the study. As Blodgett and Gerber Hospitals typically do not see enough asthma patients to warant hiring research staff, on-staff respiratory therapists at Blodgett and Gerber Hospitals were trained by the study coordinator with the expectation that they would screen potential participants, obtain informed consent and enroll patients, and conduct interviews at their respective sites. Available staff at Butterworth Hospital (1.5 full-time equivalents) provided an average of 60 hours per wwk of coverage. A medical student worked occasional night and weekend shilts up to 16 hours per week of additional coverage. Data collected then were representative of patients who visited during the day and evening hours; but as there was little ovemight coverage, patients who sought urgent asthma treatment after 11:00pm were undenepresented in this sample. lnlbrmed consent When interviewers identified a patient in the ED with asthma symptoms, they approached the parents while the child was being treated to make a determination of eligibility. After the interviewer completed the screening criteria form (Appendix B) and determined eligibility, she informed parents and children about the objectives and prowdures of the study and asked if they and their child were interested in participating. Patients were not paid to participate nor were there ary dimct benefits from being in the study. A screening log was used to record reasons for inclusion or exclusion for those 33 patients who met the definition of asthma (see Screening Log, Appendix C). Interviews did not commence until informed written consent was obtained from the parents or guardians and assent was received from the children (see Consent and Assent Forms, Appendix D—F). Parents gave consent for their children less than 18 years (Consent Form, Appendix D); a separate assent form was signed by childmn Damn the ages of 7 and 14 years (Assent Form, Appendix E); and youths aged 15—17 years gave their own signed consent (Assent Form, Appendix F). All participants were given a copy of their signed informed consent/assent forms with the telephone numbers of contact persons in the event that they had any questions or concerns about the study. The study was approved by the institutional review boards at Michigan State University, Spectrum Health, the Michigan Department of Community Health, and the Centers for Disease Control and Prevention. Emergency visit inten/iew Interviewers completed a 31-item questionnaire in the ED with the family and patient (see Child Cohort Visit Form, Amndix G). The questionnaire was organized into six sections pertaining to patient demographic information, asthma history, usual asthma care, current asthma treatment, management and control, emergency asthma care, aid general awareness about asthma. Baseline characteristics—The following soclodemographic lnfonnation was collected for each participant: birthdate, sex, race and ethnicity, education level of the attending parent, and child’s health insurance status (see section A, Child Cohort Visit Form, Appendix G). Patients were asked whether their asthma had been previously 34 diagnosed byadoctorandatwhatagetheyhad beendiagnmd (seesection 8, Child Cohort Visit Form, Appendix G). Asthma severity—To assess the level of underlying asthma severity in the 4 weeks prior to the energency depatrnent visit, patients were asked four questions: (1) what was the frequency of daytime asthma symptoms, (2) what was the frequency of nighttime asthma symptoms; (3) the number of times over this 4-week period that the child’s activities had been affected or reshided; and (4) the number of times in the 4— week period that exacerbations severe enough to limit the child’s speech had occurred (see section 8, Child Cohort Visit Form, Appendix G). Usual asthma care—Patients were first asked if they had a primary care provider and then if they had a regular asthma care provider (RACP), i.e., a health professional, such as a family doctor or pediatric nurse practitioner, who took primary responsibility for the child’s asthma care. To establish whether patients were receiving mgular asthma care, parents were asked how many times in the past year children had made regularly scheduled visits to their asthma care providers and how long it had been since the last visit. For those without a primary care provider, participants were asked fiom what type of doctor, provider, or clinic firey received regular asthma care. Interviewers queried wl'retha patients with a regular asthma care provider (RACP) had visited an asthma specialist in the past year (see section C, Appendix G.) Cunent asthma treatment and self-management—All names of prescription and non-prescription medications taken in the preceding 4 weeks (including doses prescribed, currentflequencyofuse, route,whetlerthedrughadnnoutardifusedin last 4 weeks) were recorded from patients’ self-reports (see section D, Appendix G). 35 Separate questions were asked specifically about the use of systemic steroids and inhaled corticosteroids. To determine whether access to medications was an issue, a question was included about the family‘s ability to get prescriptions filled. Self-rnonitoring practices of patients were assessed by enquiring of patients if they had a spacer and a peak flow meter (PFM) and how frequently they used these devices. Parents were asked whether their children had ever been given a written asthma action plan. With respect to asthma education, parents were asked whether they and their child had ever received education about asthma control and treatment from a health professional. They were then asked what they had specifically Ieamed: things that trigger their asthma; medications and treatments; how to use a PFM; how to use an inhaler or nebulizer, how to use a written asthma action plan; and what to do during an asthma attack. History of emergency tare—Patients self-reported history of the following was documented: ever hospitalized for treatment of asthma symptoms; ever gone to the emergency department for urgent treatment of asthma symptoms (before this visit); and number of hospitalizations, emergency visits, and urgent care visits (at a doctor’s office or clinic) in the past year (see section E, Appendix G). Parents were also asked where they usually took their child when he/she was experiencing problems with asthma and their reasons for selecting that particular health care option. Asthma awareness— To measure general understanding about asthma, parents answered true or false to the following three statements: (i) “most people with asthma can become free of asthma with proper treatment,” (ii) “asthma is characterized by inflammation of the airways, which if controlled, can greatly reduce symptoms,” and (iii) 36 “if someone with asthma bels well, it is okay to stop taking their medication” (see section F, Appendix G). Chart abstraction Following the ED visit, the interviewers abstracted relevant clinical information from medical charts onto a clinical data form (see Clinical Data Form, Appendix H). Information collected included initial signs and symptoms upon presentation (breatl'rlessness, speech, breath sounds, degree of labored breathing, and presence of cough); peak flow and oximetry measurements; treatments received in the ED; discharge medications; asthma supplies and education mceived while in the ED; and any follow-up reminders and referrals given. The table on asthma signs on presentation shown in section 4 of the clinical data form (Appendix H) was constructed based on the NAEPP Guidelines. Follow-up interviews ThecohortofButterworth childrenwasfollovved upontwooccasions: twoweeksand six months following the initial ED visit Research staff at Butterworth conducted all follow-up telephone interviews with parents and entered all data into a Microsoft Access® database. Two-liveek follow-up sun/ey—Two weeks after the initial ED visit, interviewers contacted the parents or guardians of the patients by telephone for a follow-up interview (see Child Cohort 2-week Follow-up Form, Appendix I). Ideally the parent who had accompanied the child to the emergency department was interviewed or if this were not possible, then another family member who was familiar with the child’s asthma care was asked to do the telephone interview. The 2-week questionnaire comprised 19 items 37 about additional urgent care visits for asthma and routine asthma visits since the ED visit (see sections A & 8, Appendix I); whether a follow-up appointment had been made with the child’s primary asthma care provider after the index ED visit (see section 8, Appendix I); compliance with discharge prescriptions (see section C, Apmndix I); and four questions on current asthma symptoms, three on asthma control, aid two on quality of life (see section 0, Appendix I). Six-month follow-up survey—Paents were again contacted by interviewers by telephone six months following the ED visit The 25-item 6-month questionnaire asked about the occurrence of asthma exacerbations since the 2-week interview that necessitated taking the child for urgent treatment, and if so, where the child was taken (see Child Cohort 6-Month Follow-up Form, Appendix J). All mpOIted urgent care and ED visits and hospitalizations were recorded (see section A, Appendix J). If the child had not seen their regular asthma care provider by the time of the 2-week interview, the parents were asked at 6 months when the drild had their follow-up asthma check-up (see section 8, Appendix J). Parents were queried how many routine asthma care visits the child had had since the 2-week interview and about any changes to the child’s asthma management. On the six-month follow-up form, information was recorded about current asthma-related medications the child had been taking in the 4 weeks leading up to the 6-month interview (see section C, Appendix J). Interviewers asked the paents for an assessment of the child’s recent asthma symptoms and control, and quality of life in the last4 weeks (see section D, Appendix J). 38 Defining asthma severity Chronic and acute severity were measured in two ways: (1) chronic underlying asthma severity during the 4-week period prior to going to the ED, and (2) clinical severity upon presentation, as measured by peak expiratory flow (PEF) measurements taken in the ED (children 27 years) and (or) by signs and symptoms of asthma upon examination. Chronic (long-term) severity Arr aggregate variable was created to define a patients overall underlying asthma severity, which was draracterized according to the most severe grade of either day- or night-time symptoms, restricted activities, or the frequency of exacerbations severe enoughtoaffectspwchthatoccurred overthe4-weekperiod precedingtheindexED visit. Questions 7—10a from ED visit form (Appendix G) are reproduced below demonstrating the cutpoints for defining mild intermittent, mild persistent, moderate persistent, and severe persistent in accordance with the NHLBI guidelines (see Table 1 on NAEPP classification of asthma severity). 7. How often in the last 4 weeks has your child had asthma symptoms during the day? (i.e., wheezing, a dry cough, shortness of breath, and/or chest tightness) Never ...................................................... 01 Less than once a week ........................... 02 } Mild intermittent 1 or 2 times a week ................................. 03 3 to 6 times a week ................................. 04 } Mild persistent Every day ................................................ 05 3 Moderate persistent Continually (all the time) ......................... 06 3 Severe persistent 39 8. HowmarrytimesovertheIast4weeksdidyourchildwakeupatnight because of asthma symptoms? (i.e., wheezing, a dry cough, shortness of breath, and/or chest tightness) Never ...................................................... 01 . . _ } Mild intermittent 1 or 2 times ............................................ 02 3 to 4 times ............................................ 03 3’ MW persistent 5 to 9 times ............................................ 04 } Moderate persistent 10 or more times ..................................... 05 3 Severe persistent 9. How many times over the last 4 weeks has your child’s activities been affected or restricted by his/her asthma symptoms? Never ...................................................... 01 )- Mi/d intermittent 1 or 2 times ............................................. 02 3* Mild persistent 3 to 4 times ............................................. 03 } Moderate persistent 5 or more times ....................................... 04 . } Severe persrstent All the time .............................................. 05 10. In the last 4 weeks has your child’s asthma symptoms ever been severe enough to limit your child’s speech to only 1 or 2 words at a time between breaths? NolYes 10a. If yes, how many times has this occurred in the last 4 weeks? Children were assigned to the moderate persistent level of severity if they experienced 28 but <20 exacerbations in the past month, and to severe persistent if they mported 220 severe episodes of asthma. To give an example of classifying chronic asthma severity, if a child reported daytime symptoms less than once a week, five episodes of nighttime symptoms in the 40 past4weeks,hadactivitiesresfiictedtwiceinflrepastmonthandfourexaoerbations, this child would be classified with moderate persistent severity. Acute (exacerbation) severity A measure of acute severity, representing the current exacerbation, was obtained by documenting the patients asthma signs and symptoms upon presentation in the emergency department and (or) the degree of airflow limitation as measured by PEF (see Table 1). Severity of the exacerbation was classified based on respiratory symptoms according to Table 6. Table 6. Classification of acute severity based on presenting signs and symptoms Sig Normal Mild Moderate Severe Breathless- None While walking While talking While at rest ness Presenta- Relaxed Mildly anxious Anxious Tense, unable tion Normal speech Speaks short to speak more phrases than 1-2 words . between breaths Breath Clear Rales/ronchi Poor aeration Minimal aeration Sounds Mild/scattered Moderate! Audible wheezing entire expiratory wheezes wheezing lnsplexp wheezes Work of None Mild intercostal Moderate Severe Breathing retractions Substernal Supraclavicular Mild AMU retractions retractions Moderate AMU Severe AMU Cough None Intermittent Frequent Constant Note: Adapted from the 1997 NAEPP Guidelines. The highest degree of breathing and speech difliculties was used to define the overall level of acute asthma severity. Thus, a child with an intermittent cough, who became breathless while talking, and from whom audible wheezing could be heard, would be classified as having a severe exacerbation. 41 In addition, for patients aged 27 acute severity was measured using PEF and compaed with eitter their personal best readings or predicted values. Predicted values were calculated from patients’ age and height, according to a predicted PEF table. A simplified version of a predicted PEF table based on height is given below. Table 7. Predicted PEF values based on height Height PEF rate (cm) (Umin)* 120 215 1 30 260 140 300 1 50 350 160 400 1 70 450 180 500 Note: *, mean; 2 SD = 1100. From Monash University (2003) PEF readings were taken pre- and post-medication while the child was in the ED. For some cases several values post-treatment were obtained if the response to medication was slow. If the pre-medication PEF reading was 280% of the predicted value, then asthma severity was classified as mild. Asthma was classified as moderate severity when the pre—treatrnent PEF measurement was >60% but 580% of the predicted value. For pre-treatment PEF measurements 560% of predicted, asthma was categorized as severe. Measures based on recommendations from the NAEPP Guidelines Questions on patient asthma care, education, and self-management histories from the survey instruments provided data for comparison with several NAEPP mcommendations. Each measure below will be used to identify a proportion of pediatric patients who reportedly met an NAEPP criterion among those enrolled in the study. 42 Measure 1 concerns the number of regulaly scheduled asthma care visits to a primary asthma care provider in the past year, categorized as <2 visits and 22visils (Q14 on the ED visit form). The NAEPP advises at least two scheduled check-ups a year for individuals with mild intermittent or mild mrsistent asthma, and more frequent check-ups for those with moderate and severe asthma. Measure 2 determines the proportion of patients age 7 and older with mmrate to severe asthma who had a peak flow meter (Q22) and how frequently they used it (Q22a). The NAEPP recommends that children aged 5 years and older, with a history of modaate to severe asthma, use a peak flow meter to monitor both the severity of an exacerbation and how well they are responding to pharmacotherapy. Measure 3 addresses the use of inhaled corticosteroids taken by patients in the 4 weeks preceding the ED visit (Q17). Patients older than age 5 with persistent asthma are recommended to take inhaled corticosteroids (low dose for _mild asthma, low to medium dose for moderate asthma, and a high dose for severe asthma) to maintain long-term control of their asthma. The NAEPP counsels that children with asthma age 5 and younger can be treated with low dose ICS for mild persistent and moderate asthma, and high dose ICS for severe asthma (NAEPP 2002). Measures 4 and 5 address the issues of a written asthma action plan and education in dealing with asthma. The ED visit form asked paticipants whether they had bwn given a written asthma action plan by their health care provider (Q23) and whether they had received education on asthma control and treatment (Q24-25). Question 24a queried patients about the specific type of asthma education they had received (asthma 43 triggers, medications and treatments, how to use an inhaler or a nebulizer, how to use a peakflowmeter,whattodocningarasthmaattack, ardhowtouseamittenactionplar). Measure 6 addresses visits to an asthma care specialist for patients who have moderate to severe persistent asthma. Two questions on the ED visit form that collected data on asthma specialists ask participants (1) who have a RACP whether they have seen an asthma specialist in the past 12 months (Q16) or (2) who don’t have a RACP, what type of doctor or provider or clinic takes primary responsibility for their mgular asthma care (Q13). Measure 7 addresses the proportion of patients who had a follow-up appointment after the index ED visit. Two questions on the 2—week follow-up questionnaire sought to establish whether the child had attended a follow-up visit with their RACP (Appendix I, Q8b) or an appointment had been made for the follow-up by the time of the 2mek interview (Appendix I, Q), given that it is sometimes difficult to get an appointment on short notice. These questions do not explicitly measure compliance, as to do so would require confirmation with the patients physician that the appointment took place (Leickly et al 1998). Statistical analyses Data from the interviews and the clinical data forms were entered into a Microsoft Access® database by the interviewers at the hospitals. As the data became available, periodic checks of the completeness and quality of the data were undertaken by research staff at the Department of Epidemiology, Michigan State University. Quality assurance reports were sent back to the hospital study coordinator to locate missing data or to interpret nonstandard responses and illogical skip patterns. Statistical analyses are listed by study objective: 44 A Demggrgghic characteristics: Proportions of demographic characteristics with 95% confidence intervals were calculated for dichotomous categorical variables using Proc Freq in SAS v8.2 (SAS Institute Inc., Cary, NC). The mean values (1:95% confidence intervals) of continuous variables (such as patient age, number of routine asthma visits) were calculated using Proc Means. B. Seven NAEPP recommendations: Frequencies (using Proc qu) with 95% confidence intervals were calculated for the seven NAEPP exposure measures under study. An array procadure follmd by Proc Freq was applied to determine the proportion of patients taking each of the different medication groups. A subgroup analysis compared adherence to the NAEPP mcommendations between children who had seen an asthma specialist and those who had not (using Pearson’s chi-square test or Fisher’s exact test if at least one cell in the contingency table was less than 5). Statistical significance was set at p<0.05. C. Asthma sevem : Aspects of asthma care, treatment, and management, hospitalization and ED visits, and follow-up visits and relapses (categorical variables) were cross-tabulated with chronic severity using Proc Freq and tested for linear trend using the Martel-Haenszel test (p<0.05). An acute severity construct categorized the severity of the ED exacerbation as previously described. Patients’ level of chronic asthma severity was also correlated with acute severity at the time of the ED visit. 45 Chapter 3 Enrollment ’ Enrollment over the first year of the project was slower than expected at Blodgett and Gerber Hospitals. Between July 2001 and September 2002, only 14 children were enrolled at Gerber Hospital and 20 at Blodgett Hospital. However, enrollment at Butterworth Hospital went well and 139 children were enrolled by September 2002, exceeding the original goal. Respiratory therapists, who had been trained to recruit and interview patients, were on staff 24 hours a day at Gerber and Blodgett Hospitals. However, owing to other hospital-wide responsibilities, they were not always available in the ED to enroll patients. Unlike the situation at Gerber and Blodgett, because of the higher volume of asthma patients, Butterworth had research staff who worked solely on the project With so few study participants from Gerber and Blodgett Hospitals, it was not possible to do a comparative analysis across the three hospital sites. Instead, we mrfonned a descriptive analysis on the data collected fiom the 139 patients from Butterworth Hospital. Baseline characteristics of participants The mean age of the 139 children was 8.410.? years, with a range of 2—17 years (Table 8). One quarter of the patients (25.9%, n=36) were less than 5 years of age; males comprised 61.1%, and African Americans made up 28.1% (n=39) of the cohort. Close to half of the parents (44.6%) had achieved no higher than a high school education; 46 according to 2000 US census estimates, 45.1% of adults 25 yeas and over have a high school education. Table 8. Baseline characteristics of children. Characteristics n Frequency (%) Number enrolled 1 39 Age 2-4 years 36 25.9 5—9 years 50 36.0 10—1 4 years 38 27.3 15—1 7 years 15 10.8 Gender (%zl: 95%Cl) Females 68 41 .2181 Males 97 58.8:I:8.1 Hispanic (% 1: 95%Cl) 21 15.2:l:5.9 Race (%) Black/African- American 39 28.1 White/Caucasian 84 60.4 Multiple 1 3 9. 3 Other 3 2 2 Parent education (%) 12 months ago 16 13.2 Note: PCP, primary care provider; RACP, regular asthma care provider. °When RACP is PCP, not specialist. bA total of 37 children had seen a specialist. 51 Patients who saw asthma specialists A total of 37 children saw an asthma specialist in fire past year. A significantly higher number of children who had visited a specialist reported that they had mceived a written asthma action plan (73.0% versus 31.4%, p<0.0001, Pearson’s x2 =19.2, 1 df) and asthma education than those who did not (89.2% versus 68.6%, p=0.0145, Pearson’s x2 :60, 1 df). Inhaled corticosteroid use was significantly higher in children who had visited a specialist (70.3%) compared with those who hadn’t (37.3%, p=0.0006, Pearson’s test x7=11.9, 1 df). Children who had seen a specialist were more likely to have a peak flow meter (84% with a specialist versus 58.9% without, p=0.027, Pearson’s test x2=4.9, 1 df). Almost 24% of children with a specialist took PF M readings daily as opposed to 9.1% of those without a specialist. Neither the occurrence of relapse visits for asthma over the 2-week period nor follow-up visits with RACP was significant Damn the two groups of childmn (relapse visits, p=0.5308, Fisher exact test; follow-up, p=0.4027, Peason’s x407. 1 df). Emergency care history Just over half of the children (54.018.3%) had wen hospitalized for asthma in their lifetime; 57.3% reported at least one in-patient visit within the last year. The majority of the children at 86.315.7% had a prior history of seeking urgent asthma treatment at an emergency department (T able 12A). More than three quarters of the patients (76.7%) had made at least one ED visit in the preceding year. When asked how many urgent visits were made to a doctor or clinic in the past year, almost 60% had made at least one; the mean number of urgent visits in the previous year to a doctor or clinic was 2.2106. 52 Table 12A. Emergency care in the past year Indicators n Frequency Ever hospitalized for asthma (%195% CI) 75 54018.3 Hospitalized in past year (%; n=75) None 32 42.7 Once 34 45.3 2-5 times 9 12.0 Ever made ED visit for asthma (%195% CI) 120 86315.7 ED visits in past year (n=120) None 28 23.3 1 ED visit 41 34.2 2 ED visits 19 15.8 3-5 ED visits 16 13.3 26 ED visits 16 13.3 Urgent visits in past year to doctor/clinic (n=139) None 56 40.3 1 urgent visit 27 19.4 2 urgent visits 21 15.1 3-5 urgent visits 21 15.1 26 urgent visits 14 10.1 Table 128. Hospitalizations for asthma by chronic severity Chronic Ever hospitalized Hospitalized in past year 39'9“” Yes (n=75) No (n=84) None (n=96) 21 (n=43) Ml (%) 43 (50.8) 33 (49.2) 48 (71.6) 19 (28.4) MP (%) 14 (58.3) 10 (41.7) 18 (75.0) 6 (25.0) Moderate (%) 11 (55.0) 9 (45-0L 12 (60.0) 8 (40.0) Severe (%) 16 (57.1 ) 12 (42.9) 18 (84.3) 10 (35.7) MH test x2 0.35 0.90 p 0.5565 0.3415 Note: Ml, mild intermittent chronic asthma; MP, mild persistent chronic asthma; MH, Mantel-Haenszel test. 53 Table 12C. ED visits for asthma by chronic severity Chronic Ever had ED visit ED visits in past year “"9"” Yes (n=120) No (n=19) - None (n=47) 21 (n=92) Ml (%) 56 (83.6) 11 (16.4) 25 (37.3) 42 (62.3 MP (%) 23 495.8) 1 (4.2) 7 (29.2) 17 (70.8 Moderate (%) 18 (90.0) 2 (10.0) 9 (45.0) 11 (55.0) Sovergvo) 23 (82.1) 5 (17.9) 6 (21.4) 22 (78.6) MH test x2 <0.01 0.11 p 0.9622 0.2923 Note: MI, mild intermittent chronic asthma; MP, mild persistent chronic asthma; MH, Mantel-Haenszel test. Table 12D. Urgent care doctor visits for asthma by chronic severity Chronic ED visits in past year “WWW None (n=56) 1—2 (n=48) >2 (n=35) Ml (%) 36 (53.7) 23 (34.3) 8 (11.9) MP (%) 6 (25.0) 10 (41.7) 8 (33.3) Moderate (%) 4 (20.0) 8 (40.0) 8 (40.0) Severe (%) 10 (35.7) 7 (25.0) 11 (39.3) MH test x2 0.89 p 0.3452 Note: MI, mild intermittent chronic asthma; MP, mild persistent chronic asthma; MH, Mantel-Haenszel test. measures evaluated (Tables 128—120). 54 We tested the association between chronic severity and emergency care history, however, no statistically significant associations were found for any of the five Asthma treatment Asthma drugs used by children in the 4~week period prior to their ED visit as reported by their paents were classified into major medication groups outlined by the NAEPP. Long-term control medications include any of the following: inhaled corticosteroids (ICS), cromolyn sodium, nedocromil, long-acting Bragonists (LABA), combined corticosteroid + long-acting Bz-agonist (e.g., Advair), methylxanthines (theophylline), and Ieukotriene modifiers (LM). Short-tenn control or quick relief medications include short-acting Bragonists (SABA), anticholinergics, and systemic (oral) corticosteroids (OC). Table 13A. Reported medication use in 4-week period before ED visit %Patients on medication Medication treatments n (1 95% Cl) Long-term control“ ICS (Pulmicort, Flovent) 64 46018.3 LABA (Serevent) 13 9.4148 Cromolyn or nedocromil , (lntal, Tilade) 5 3613.1 LM (e.g., Singulair) 24 17316.3 CSBA (e.g., Advair) 20 14.4158 Theophylline 1 0.711 .4* Short-acting control‘ SABA (e.g., albuterol) 118 849160 Anticholinergics (e.g., Atrovent) 5 3.6131 Oral corticosteroids (%) 28 24.8 Miscellaneous Allergy medications (e.g., Zyrtec) 25 1 8016.4 Nasal sprays (e.g., Flonase) 11 7.9145 Note: CSBA, corticosteroid + long-acting B—agonist combined; ICS, inhaled corticosteroid; LM, Ieukotriene modifiers; LABA, long-acting B-agonist; SABA, short-acting B-agonist. aCategories of medications as per the NAEPP (2002) *CI exceeds 95% possible limits. 55 Based on parents’ reports, each child used an average of 2.7 medications for their asthma in the 4-week period prior to coming to the ED. SABA (e.g., albuterol) and ICS (such as budesonide or fluticasone) were the most common prescription medications used (Table 13A). We evaluated the association between the level of chronic severity and medication use (Table 13B). Reported use of SABAwas high across all levels of severity but was not associated with increasing severity (p=0.146). Statistically significant associations were identified between severity and ICS, LABA, LM, and OC use. ICS use was reported by 58.3111.4% of children with mrsistent asthma and by almost 70% (67.9117.3%) of patients with severe persistent asthma. Appropriateness of medication use Eighteen children (13.015.6%) were not taking any asthma medication, either short- or long-acting; 15 of these were mild intermittent, however, 3 were considered to have moderate to severe chronic asthma. F ilty-eight percent of moderate to severe asthma patients were undertreabd. Almost 20% (18.8%) of these children were not taking any Iong-tenn control medication (Table 130). The proportion of patients with moderate to severe asthma who were taking the following drugs as their mly long-tenn control medication was as follows: ICS only, 37.5% (n=18); and LABA and Ieukotriene modifiers, 2.1% (n=1). 56 .68.. 8358.0. .95 80. 88:02.. .255. .15. 5:08.... 085... $3 SE05... 08.88... 80.2 .szfiw o.:o....0 .5889. RE .n.s. .chfim 0.8...0 .coEEoE. 0...: ...2 ”8.59.-.. 85.00.68 . OZ mm> OZ ww> OZ wm> OZ mm> OZ wm> 2:950 a. «p.22... .80 a. s... a. <80 8. <9: .5 mo. 8. <98 3.88m mEcfim 0.8....0 E ..m.> cm. 0. 6.... 9.8.... v C. can 3.8.0.8.). .mnw 0.2g 57 Table 130. Long-term control medication use pre-ED visit by chronic severity Chronic lCS+Alt Tx LTC meds No LTC severity ICS+LABA (LM, CN) ICS only oriy (no or ICS Tx Ml(%) (n=31) (n=9) (n=41) |C$)(n=4) (n=54) n=67) 9 (13.4) 2 (3.0) 18 (26.9) 2 (3.0) 36 (53.7) MP (n=24) 7 (29.2) 2 (8.3) 5 (20.8) 1 (4.2) 9 (37.5) Mod/Sev (n=48) 15 (31.3) 5 (10.4) 18 (37.5) 1 (2.1) 9 (18.8) Note: Alt, alternative treatment; CN, cromolyn or necrodomil; ICS, inhaled corticosteroids, LABA, long-acting B-agonist; LM, Ieukotriene modifier, LTC, long- term control; Ml, mild intermittent asthma; MP mild persistent chronic asthma; Mod/Sev, moderate to severe persistent asthma; TX, treatment. Among the children with moderate to severe asthma, 41.7% were appropriately treated wim ICS and LABA, CSBA, or ICS with a long-term control alternative (Ieukotriene modifiers, cromolyn, or necrodomil). Forty-three percent of children with mild intermittent asthma were reported to have used inhaled corticosteroids in the month preceding their ED visit. Table 14. Asthma treatment: Use of systemic corticosteroids Corticosteroid use n Frequency Ever used steroids given orally or by injection (%195% CI) 113 81.9164 Used steroids in 4-week period prior to ED visit (%195% CI) 29* 25.7181 Duration of oral steroid use in 4—week period prior to ED visit (%) 1—2 days 10 35.7 3—5 days 10 35.7 6—1 0 days 5 17.9 >10 days 3 10.7 Days since oral steroids taken (%) Currently on steroids 10 35.7 1—5 days 8 28.6 6—1 0 days 2 7.1 11—20 days 2 7.1 21-30 days 6 21.4 Note: *One by injection. 58 When parents were asked directly if their child had ever taken systemic steroids, either orally or by injection, 81.916.4% said yes; 25.718.1% said they had taken steroids in the 4-week period before coming to the ED (Table 14). Ten children were on oral steroids when they were brought to the ED. Of the 59 patients were not currently taking ICS at the time of the ED visit, approximately one third (33.9%, n=20) reported that they had ever used ICS. Among the 17 patients who said they had taken ICS, the mean duration of a course of ICS was 210411681 days (range, 7-1095 days) and the mean time since patients were last on ICS was 434512045 days (range, 42—1460 days). Most parents were able to get asthma prescriptions filled for their children (91.314.7%). Among the 12 children whose parents expressed difficulties in obtaining medication, reasons included financial and insurance problems, and pharmacy not having medication in stock. Asthma management and control Only 61.918.1% of children possessed a spacer, which is used in conjunction with a metered dose inhaler (Table 15). Among children with a spacer, 33% reported that they didn’t always use it. The study restricted the question of whether they had a peak flow meter to children aged 7 and older. While 66.7110.3% said they had a PFM, 46.3% admitted to using it only during an asthma attack. 59 Table 15. Asthma control and management Use of asthma equipment It Frequency Have a spacer (%195% CI) 86 61.9181 Use of spacer (%) Never 8 9.4 Rarely 5 5.9 Occasionally 8 9.4 Usually 7 8.2 Always 57 67.1 Have a peak flow monitor (PFM; 27 years) (%195% CI) 54 66.71103 Use of PFM (%) Rarely 9 16.7 83.32.... a 2.8.: <. .86.. 8.8 E 8.8.8.8 8:58.. :8 2.8 .0 82.83.... 2:58... 828... .m ”.8... 5...... «E88 :6 62.... .v 820888.50 8.2.... 98.8. .m ”.26.: 3.... .60.. a o>a.. .N ”8.... 8.... o... E 3:389... «£5.08 8.38.. .. .m:o..au..wEEoow. mam/.2 ..m... 88:06... R8... .88... 88... 88.... .88... 88... 88... .. ..N... E... 8... 8... 8... : 8... 8.. N.. .8. ...s. 8.8. 8.... 8.8. 8N... ..Nm. 8.8. 8.8. ...8... ..N8. 8.8. 8.8N. 8.... 8.8. ...o... 8N": 8. .. m. N. m m. m. 8. m m. .. 8. m. 8. >88 68. 8...... 8.8. 8.8. .8N. 8.81.. .88 ...m... 8...... 8.8. 8.8. 8.8. 8...... ...8N. 8N"... N. 8 8. . m m. .. m 8 N. m 8 m. m .85 8.8... 8.8. 88.. 8Nl.. 8.8. 8.8.. 88. .8... 8...... 8.8... 88. .8... 8.8 8.9.. ...Nu... o. 8. 8. m 8 m. 8. .. 8. : .. .. 8. .. .5 .88. 8.8... 8.8. ...NN. ...8N. 8.... 88. .88. 8.8. 88. .88. ...8. 8.... ...Nm. .8“...L 88 ..N 8 m. t 8 .. 8N 8.. NN .. N8 8 mm .5 .8 .8. .6... .8. 8... 8.... .8. .8. 8.. .8. .8. ...m. 8.. .N... .5. oz 8.. oz 8.. oz 8.. oz 8.. oz 8.. 62 8> NM Nv 25.9. .c... .c o c m .c .. 8 8 .. N 8. 8.2.... 3:98 9:53 2:25 55> mco..mu..mEEoom. n.n.m.....z .o 8:88.: .o cow..m..Eoo .o~ 2...... 67 Chapter 4 This study examines the consistency of asthma we and management with the NAEPP Guidelines among a cohort of children attending a midwestem hospital emergency department for their asthma. Studies of suboptimal asthma we, treatment, and management among ED patients, i.e., nonadherence to the NAEPP Guidelines, have been published previously; however, the focus has centered primarily on disparities of are in inner city, minority, poor, and managed care study populations (Crain et al. 1995; Ali and Osberg 1997; Vollmer et al. 1997; Legorreta et al. 1998; Doerschug et al. 1999; Rand et al. 2000). Participants in the Buttemorti‘i ED cohort study were 60% Caucwsian and almost all had access to primary we and heailh we coverage. Yet despite the childmn having primary care providers, a substantial proportion reported asthma we and treatment that was inconsistent with the NAEPP Guidelines. Timeliness and quality of primary asthma we may be important predictors of asthma outcomes. Poor routine asthma are has been associated with higher emergency visit rates among inner-city African-Americwn males with asthma (Murray et al. 1997). Thetotal numberofasthma patientsenrolledbytheti'ireeEDs overthestudyperiod did not meet the desired sample size estimate of 385. The slow recruitment over the course of me enrollment mriod may have been due in part to a mild fall and winter in 2001, which brought in few asthma patients. Butterworth sees more asthma patients than the other two smaller hospitals and thus sumded in enrolling its share of the study sample. The inability to mcruit and enroll the required number of participants at Blodgett and Gerber was due to several factors. Study personnel were on site at 68 Butterworth Hospital, and thus were able to periodically survey the ED for potential participants and remind ED staff to call when an asthma patient mme into the ED. Respiratory therapists at Blodgett and Gerber Hospitals had been expected to do the recruiting and enrollment, but lack of time while in the ED and their duties elsewhere in the hospital prevented them from recruiting patients. Lack of participation in the study on the part of the respiratory therapists stemmed from not only the extensive paperwork that was required for the recruitment and enrollment each patient (consent forms, screening log, cliniml data form, ED visit interview), but also from unexpected barriers to reimbursing the respiratory therapists for their time and effort. The original intent of the study had planned to directly compensate respiratory therapists $50 for each patient they enrolled, but this incentive proposal was rejected by the hospital, which was in favor of having the funds paid directly into a general education fund. As an inducement to bolster enrollment at Blodgett and Gerber, a gift card was awarded quarterly to the respiratory therapist who enrolled the most patients. Butterworth Hospital’s newly opened pediatric emergency department also caused a shift in ED use in that parents who reside in the Grand Rapids area preferred to take their sick children to Butterworth for pediatric emergency are rather than Blodgett Hospital, which does not have a pediatric ED. Although interviewer availability at Butterworth was not 24 hours a day, coverage of the ED was considered more than adequate with the anangement of shift schedules among the three interviewers. There is a greater representation of patients who presented during the day and evening than of those who sought treatment at night, but this is unlikely to have biased the results in an appreciable way. 69 ThestudYs research nurseswere highly successful in contacting parents ofpatients at the 2-week follow-up interview, obtaining a 96.4% participation response. This proportion was higher than those reported in the cohort studies of Stevens et al. (85%, 2-week follow-up) and Butz et al. (88%, 8m follow-up). Inability to contad patients for telephone follow-up was associated with age, gender, race, and socimconomic statusinaprospectivecohonstudyofadultandpediatlicEDpatientswimasmmaof the Multicenter Ainlvay Rewarch Collaboration (Boudreaux et al. 2000). Boudreaux et al. reported that they were more successful at contacting pediatric patients (87%) than adults (71%) at the Z-mek telephone follow-up. Techniques in conducting follow-up may also improve the chances of making contact increasing the number of call attempts, asking for altemative numbers at the initial ED interview and best times to call. Comparison of the Grand Rapids Children '3 Asthma Cohort Study with similar reports in the literature The higher proportion of male patients with asthma than females in Butterworth ED study reflects the higher prevalence of asthma found among boys than girls (Gissler et al. 1999; Wleringa et al. 1999; Bjomson and Mitchell 2000). Butterworth patients (mean age 8.4 years) tended to be slightly older than the children in the ED studies previously reviewed (mean age range, 6.5—8.4 years) (Davidson et al. 1994; Dinkevich et al. 1998; Ferris et al. 2001; Scarfone et al. 2001; Stevens and Gorelick 2001). Just over half of the Butterworth ED children were diagnosed with asthma before the age of two (52%); this finding is similar to the ED study of Ferris et al. (2001), who reported that parents most often gave two years as the age of their child’s diagnosis. Typical also of the high proportion of patients with Medicaid coverage in the ED articles reviewed in Chapter 1, almost half of the Butterworth study group had health coverage through Medicaid 70 (46.8%). In five out of seven ED studies, patients with Medicaid coverage comprised 50% or higher of the study population (Davidson et al. 1994; Crain et al. 1998; Dinkevich et al. 1998; Scarfone et al. 2001; Stevens, and Gorelick 2001) (Table 5). African Americans comprised a much larger proportion of the ED study group (28.1%) than the 9% they represent of the Kent County population, as did Hispanic patients (15.1% of the ED cohort versus 7%-of the Grand Rapids population) (US Census 2002). In seven of nine ED studies, the proportion of African Americans comprised a substantial proportion of the patient population, ranging from 54 to 100% of the pediatric asthma ED patients (Butz et al. 199; Friday et al. 1997; Crain et al. 1998; Ferris et al. 2001; Farber et al. 1998; Stevens and Gorelick 2001; Scarfone et al. 2001) (Table 5). The Hispanic patient component of these ED studies ranged from 13 to 61% (Davidson et al. 1994; Crain et al. 1998; Dinkevich et al. 1998; Ferris et al. 2001). Using data from the 1988 National Health Interview Survey, Halfon et al. found that race, education, family structure, place of residence, and usual source of routine are were among the strongest pmdictors for emergency department use; Medimid coverage was not associated with the use of the emergency department for sick care, but rather other factors may account for the Medicaid effect (Halfon et al. 1996). At 60%, our study had a higher representation of Caumsian patients than the nine asthma ED studies reviewed, six of which took place in inner city hospitals (Table 5). The Buttenlvorth ED study participants thus offer insight into NAEPP asthma guideline adherence in a group that one might expect to have better access to primary medical are and that may not face the same risks for asthma as children living in larger inner cities elsewhere. 71 Asthma care Children who used emergency services at this Grand Rapids hospital had access to primalywre, with95% listingaproviderand85%ofwhomwerereportedtohave provided regular asthma are. However, only just over half of the cohort had two or more regularly scheduled asthma care visits in the year prior to the ED visit (in accordance with the NAEPP guidelines). Slightly more than one quater of the cohort (26.6%) saw an asthma specialist either for their primary asthma are or in addition to their regular asthma are. As expected, patients with more severe asthma were more likely to have seen an asthma specialist than those with milder asthma (severe asthma, 42.9% vs. mild intermittent, 22.4%; p=0.0295). Wten measures of asthma edumfion, management, and control were compared, significant differences were found between tl'losepatientswhohadseenanastl'imaspecialistinthepastyearandthosemhohad not (edumfion, 89.2% vs. 68.6%; asthma action plan, 73.0% vs. 31.4%; and ICS use, 70.3% vs. 37.3%). However, given the nature of the study design, it is not possible to discern the exact role of the specialist in contributing to these differences. (The decision to have a consultation with a specialist is driven, in part, by severity, which may also drivetheuseoftheseotl‘lermeasures.)Therewas, however, nodifferencebetweenthe two groups in occurrences of either relapse or post-ED care visits by the 2-week follow- up interview. In several cross-sectional surveys of patients in managed care organizations, asthma are and treatment were more consistent with NAEPP Guidelines when patients were seen by asthma specialists rather than by generalists or primary we physicians (Legorreta et al. 1998; Diette et al. 2001; Wu et al. 2001). Integrating we by 72 an asthma specialist with that of a primary provider as part of a disease management program may be more easily implemented, and in fact encouraged, within managed we organizations (Vollmer et al. 1997). In a randomized study of health plan members aged 6—59 years, asthma care and treatment received after an ED visit was compared in one group of patients who were assigned to see an asthma specialist (n=149) with a control group who were assigned to a mneralist physician (n=160) (Zeiger et al. 1991). In the intervention group, nighttime symptoms were reduced 75%, inhaled corticosteroid use was 3.6 times higher, and ED relapses fell by almost 50% by the 6-month follow- up. ltshouldbenotedthatasthiswasanolderstudy,thebaselineratesinthe generalist group were likely much lower than those of today. In a second mndomized trial of 300 asthma patients aged 2—17 years recruited in an inner city pediatric ED to test the efimcy of a comprehensive asthma program, there were significantly fewer hospitalizations and ED visits in the group assigned to a specialty clinic (Harish et al. 2001). However, this study, which required patients to complete at least nine completed questionnaires, was plagued with poor follow-up. A potential bias may exist if patients who completed the study were different from those who dropped out. Asthma severity Controversy exists over the issue of how best to classify the asthma severity of patients. The NAEPP Guidelines categorize asthma severity according to the frequency of asthma symptoms and also to PEF or FEV1 readings; however, they do not expound upon a unified methodology for collecting data on asthma symptoms. Comparing the frequency distribution of asthma severity measured in our study with the selected ED studies previously reviewed is difficult, as various methods were used to determine 73 severity. Of the four articles reviewed that categorized severity, only the Scarfone article assessed chronic asthma severity by symptom frequency as per the NAEPP guidelines. Severity was classified as either persistent or mild intermittent based on the highest frequency of daytime or nighttime symptoms over a 3-month period prior to the ED visit (R. Scarfone, personal communication). In our study, looking at symptoms over a shorter period (1 month), we also included the frequency of restricted activities into the chronic severity construct, as we were concemed that basing a patient’s overall severity on just recent daytime or nighttime symptoms may result in an underestimation. (Colice et al. 1999; Fuhlbrigge et al. 2002) Severe nighttime symptoms and restricted activities of the Butterworth children contributed more to the overall severe category of chronic severity than did daytime symptoms (Fig. 3). Nevertheless, in Scarfone’s survey of children at an urban pediatric ED, there was a higher proportion of persistent asthma: 36% mild intermittent/64% persistent severity versus our 48% (mild intermittent/52% persistent. In another study by Warman, asthma severity was measured by applying the NAEPP daytime and nighttime symptom criteria only (Warman et al. 2001). This study population of children, who had visited an inner city medical center, had a high proportion with persistent asthma (83%), yet only 35% were on daily anti- inflammatories. Children wt'io were classified with moderate to severe asthma had significantly more ED visits in the previous 6 months than children with mild intermittent or mild persistent asthma. There was a trend towards more hospitalizations in the past 12 months with increasing asthma severity, but this was not significant (Warman et al. 2001). By contrast, among the Buttenlvorth children (31% of whom had been 74 hospitalized at least once in the past year), no significant relationship was detected between chronic asthma severity and hospitalizations or ED visits in the past year (Tables 12B—12C). Initially our severity aggregate also factored in the number of exacerbations patients had experienwd in the month before the ED visit, but it did not greatly alter the classification of severity. No lung function data, such as PEF, on patients vmre available forthe month preceding the ED visit. It is possible that the level of severity assigned to the Butterworth study participants may be an underestimation of their actual underlying severity, given that the NAEPP Guidelines for severity classification apply to clinical features in M of asthma medication. In the 4~week pre-ED visit period during which chronic severity was assessed, 61% of the children were reported to have used at least one long-acting control medication. The assigned severity level of the Butterworth children more accurately reflects the degree of their asthma control. Almost half of the study group (48.2%) was classified as having mild intermittent asthma during this time period. Nevertheless, despite the limitations of our severity construct, trends in several measures suggest that this aggregate is capturing something. The determination of the underlying asthma severity by the physician is the basis for determining asthma (are and treatment (Wolfenden et al. 2003). A physician may be unaware of a patient’s recent asthma symptoms, owing to infrequent patient contact (Wolfenden et al. 2003). When questioned, patbnts with asthma may downplay their symptoms, resulting in an underestimation by the physician and subsequent undertreatment An incorrect or outdated clinical assessment of severity can result in 75 inappropriately prescribed asthma medications and dosages (Meijer et al. 1997; Wolbnden et al. 2003) and may contribute to poor adherence to NAEPP Guidelines (Haltemian et al. 2002). The potential for underestimation of severity underscores the importance of periodic asthma checkups and for patients to maintain a regular didogue with their RACP, and to have a valid, repeatable, consistent, and practical method for assessing severity. Children who had been swn by their primary physicians in the past 6 months were more likely to have been correctly classified in a study by Halterrnan et al., who considered the parents’ description of asthma symptoms as the gold standard measure of their child’s severity (Haltennan et al. 2002). Peak flow monitoring is useful for the assessment of the severity of exacerbations (NAEPP 1997). Acute severity measured by pre-treatment PEF identified 31 Buttenrvorth patients aged 7 and older as severe, whereas only 12 of these patients were assigned to the severe category when acute severity was measumd by the clinical evaluation of respiratory signs and symptoms, suggesting that symptom-based measures may underestimate severity. The Colice study found poor correlation between asthma severity detemined by the symptom-based NAEPP criteria and lung function measures (Colice et al. 1999). As anticipated, our analysis showed no correlation between chronic asmma severity intl'le4weekspriortotheEDvisitandacuteseverity measuredattheED.The underlying chronic pathology of asthma is thought to differ from the acute exacerbations of bronchoconstriction and airflow limitation caused by a variety of asthma triggers. More research and guidance from the NAEPP is needed to correctly classify asthma severity. Categorizing asthma severity based on hospitalization and ED visits, 76 asdoneintheCrain EDstudyandtwoMedicaidstudiesonasthmacarereceivedby children with asthma, is problematic in that it captures issues other than just the severity of asthma symptoms, such as parent perception of disease, access to care, and adherence to appropriate therapy (Crain et al. 1998; Bauchner 2000; Apter et al. 2001; Shields et al. 2002). As it stands now, measuring asthma severity is subject to wide interpretation of the NAEPP Guidelines. A validated method for the categorization of asthma severity would be a welcome tool for both clinicians and asthma researchers (Colice et al. 1999). Asthma control and management The July 2002 NAEPP Guidelines recommend ICS and long-acting B—agonists (LABA), for the treatment of patients with moderate and severe asthma; patients with severe asthma may require oral steroids in addition, if needed (NAEPP 2002). One noticeable difference from the nine ED articles reviewed has been the higher use of ICS mported by the Buttenrvorth patients (46.0% overall, 64.6% among those with moderate/severe asthma, and 70.3% of those who saw an asthma specialist) and less reliance on cromolyn/necrodomil (3.6%, n=5) and theophylline (0.7%, n=1), as these medications have been substituted by more effective asthma dmgs (Barnes 1997). Although the NAEPP does not recommend ICS for mild intermittent asthma, 32.8% of children so classified reported ICS use. This suggests that either these children experience episodic acute attacks or their severity classification in reality reflects how well their medication is controlling their symptoms. Only 22.3% of patients were taking ICS and LABA either as two separate medications or as one combination therapy. Almost 97% of the Butterworth patients on 77 ICS and LABA also mported that they used short-acting B—agonists (albuterol) for quick relief. LABA provide effective bronchodilation but have no anti-inflammatory effects and so should be used in combination with ICS to effectively control asthma symptoms (Bames 1997). None of the nine reviewed ED studies had data about LABA use. Salrneterol (an LABA) was approved for market in 1994 and was listed as an alternative medication in the 1997 Guidelines. Since that time the NAEPP has gathered stronger evidence from numerous clinical trials that the combination of LABA and ICS improves lung function and overall asthma control and reduces the number of severe asthma exacerbations among moderate to severe asthmatics (Aronson et al. 2001; NAEPP 2002), although it should be noted that many of these trials were sponsored by pharmaceutical companies that manufacture a combination therapy inhaler (Glaxo Wellcome and AstraZeneca). While this study ended two months after the publication of the July 2002 NAEPP update, our LABA data provide a baseline from which to track progress in the use of LABA among moderate and severe asthma patients. There is a need to promote this latest recommendation of combination therapy for moderate to severe asthma patients among primary asthma care physicians. Age of the child has been an important consideration wlen prescribing ICS, in particular, because of potential side effects such as growth, bone density, ocular toxicity and suppression of the hypothalamic-pituitary-admnal axis (Bames 1995; NAEPP 2002). Despite the lack of studies comparing corticosteroids and other long-term medication in children less than 5 years of age, the NAEPP advocates that they be treated with low-dose ICS. Our results showed that 52.8116.3% of the Buttenlvorth ED children under 5 were prescribed ICS. From a 1997 primary physicians’ survey, inhaled 78 corticosteroids were prescribed by 60.5% of physicians for patients under 5 years of age and by 95.7% of physicians for patients 5 years and older (Grant et al. 1999). Alter ICS, use of leukotriene modifiers was the second most commonly reported long-term control medication (17.3% of the patients). Leukotriene modifiers we considered an alternative medication to LABA and can also be used in combination with ICS for moderate and mild persistent asthma. (NAEPP 2002) In our study, 18.8% of childmn on ICS were also reported taking leukoh'iene modifiers. Scarfone did not include data on Ieukotriene antagonists, as so few patients were taking these medications (Scarfone et al. 2001). Use of the combination inhaler (LABA and ICS) is thought to improve compliance, give better control of asthma, and be preferred among patients (Barnes and Connor 1995); in our study, parents indicated that 14.4% of the chilcren were taking this particular medication. Fifteen of the eighteen childen vrrho were not taking any quick relief or long-acting medication had mild intermittent asthma. Of the 48 children with chronic moderate to severe asthma, we estimate that 18.8% were undertreated, as they were not taking long-acting control medication of any kind. Another 40% of moderate to severe asthma patients were likely undertreated for their level of severity, as they were taking either ICS or long-acting control medication, such as Ieukotriene modifiers, LABA, or cromolyn/necrodomil, but without the benefit of ICS. Necrodomil has some anti- inflarnmatory properties, but ICS are considered more effective anti-inflammatories. Possession of the appropriate asthma equipment is essential to good asthma control practices. Spacers facilitate the delivery of medication to the lungs and make metered dose inhalers easier for childmn to use (Kemp and Kemp 2001). Almost 40% 79 of the Butterworth children did not have a spacer and among those who did, a third did not always use it with their inhaler. (Our questionnaire did not ask directly if patients had an inhaler. Although based on the types of inhaler medication the parents mported, the proportion of children using inhalers must have been over 80%.) Among those childmn in Crain’s clinic and ED study who had been prescribed inhaler medication, 39.5% had a spacer (Crain et al. 1998). In Swrfone’s survey, 80% of the children had an inhaler, butofthosewhoused itmgularly, 48% didnotroutinelyuseaspacerwith it(Scarfone et al. 2001). Between 13.7 and45%ofpatientshad beenprescribedapeakflow meter inthe earlier studies by Grain and Scarfone, but two thirds of the Scarfone patients did not use their PFMs (Crain et al. 1998; Scarfone et al. 2001). It is encouraging that the ownership of PFM appears to be increasing over time, as our study found that 67% of patients aged 7 and over had a PFM. However, almost half of these children (46.3%) stated they used their PFMs only during attacks and therefore not on a regular basis. Ownership of PF Ms was more prevalent among Buttenrvorth ED d'iildren with moderate to severe asthma than among those with mild intermittent asthma (70% vs. 61.1%), although this diffemnce was not significant. A high proportion of children visiting E05 and medical centers for urgent asthma do not have asthma action plans. Evidence suggests the use of asthma action plans can reduce hospitalizations and ED visits (Ordonez et al. 1998; Meurer et al. 2000). In our study, 57.5% of the Buttenlvorth ED patients reported that they did not have an asthma action plan. This finding is fairiy consistent regardless of the study. Warman’s telephone survey of parents of 2- to 12-year-olds, who had been hospitalized for asthma in the 80 past year at an inner city New York hospital, reported that only 51% had a written asthma action plan (Warman et al. 1999). In a survey of 318 parents of patients (5-17 years) who were members of two managed care organizations, 49% had written instructions for dealing with an exacerbation (Diette et al. 2001a). Many Chicago-area primary care physicians in a 1997 survey stated that they did not give written asthma treatment plans to their asthma patients; they wrote up plans for only about half of their moderate to severe asthma patients (Grant et al. 1999). It is not known whether the doctors were unaware that this was recommended in the Guidelines or whether time constraints or other factors were to blame. Asthma education In general, asthma education programs that teach self-management skills to patients are more successful than those that are strictly knowledge-based (Kennedy et al. 2003). Providing information alone has had little impact on improved asthma outcomes (Bemard-Bonnin et al. 1995; Gibson et al. 2001). In a meta-analysis of 32 eligible trials, asthma self-management education programs for children that taught strategies related to prevention and attack management resulted in improved physiological function, decreawd asthma morbidity, and reduced health care utilization (Wolf et al. 2003). The emphasis on patient education reflects the importance of the patients role in managing his/her asthma symptoms. Unfortunately, we have little information on the scope of asthma education that the Butterworth ED patients had received, other than the topics the respiratory therapist typically covers during an ED visit and what the pamnts reported. Without a comparison group, our data on education are difficult to interpret. 81 The NAEPP advocates asthma education not only for the patients but also for the physicians. Physicians who mceived asthma education as part of a clinical trial were more likely to prescribe ICS to new pediatric patients, and; to give written instructions to patients on how to adjust medications md modify therapy when symptoms change (Clark et al. 1998; Clark et al. 2000). Long-term outcomes inclmd fewer hospitalizations for asthma and, among those who had higher levels of emergency use, fewer subsequent ED visits (Clark et al. 2000). However, this study suffered a 68% attrition rate; in addition, child‘en with a history of higher hospital use were more likely to have been in the intervention arm (physicians receiving education). It should be noted that the next study being conducted in Grand Rapids involves an educational intervention on physicians. Follow-up appointments Approximately one third of the Butterworth ED patients reported that they had gone for a post-ED checkup when contacted two weeks after the ED visit, while an additional 13% had pending appointments. Patient noncompliance with follow-up appointments is well documented and may be responsible for continued disease activity (Scarfone et al. 1996; Leickly et al. 1998). Noncompliance with instructions to go for a follow-up visit eitherwitha PCP oratthe ED rangesfiom 33to 75% (Scarfoneetal. 1996; Thomas 1996; Leickly et al. 1998; Oregon Department of Human Services 2002). In a multisite longitudinal study on barriers to adhemnce, parents were asked whether a follow-up appointmenthad been madefortheirchildbeforetheyleftthe ED aftertreatrnentfor acute asthma or whether they were advised to make one (Leickly et al. 1998). When a follow-up appointment was scheduled for the patient before discharge from the ED, 82 69% of 3- to 9-year olds kept their appointments; when their parents were instructed to make a follow-up appointment, compliance was 60%; and when an appointment was not made at discharge nor were parents advised to makean appointment, only 25% of parents took their children in for follow-up care (Leickly et al. 1998). Patients may face several barriers to follow-up care, for example, they may not be able to get through to their RACP by phone to book a follow-up visit (Leickly et al. 1998). Other factors associated with noncompliance with follow-up instructions included improved health of child, parents’ perception of the degree of child’s illness, parents younger than 21 years of age, parent was working or too busy, and parent had no means of transportation (Scarfone et al. 1996; Leickly et al. 1998). Post ED visit relapses Our relapse rate of 10.5:I:5.2% compares well with the 10% incidence of relapse reported in two cohort studies: one, a prospective inception cohort study of children, aged 2—17 years, conducted in 44 EDs (Ememlan et al. 2001); and the second, a one- year retrospective chart-review study of 422 patients aged 5 months to 17 years who had attended an emergency department for asthma (Barnett and Oberklaid 1991). In an older study of a prospective cohort followed after discharge from a children’s hospital emergency department reported a 31% relapse rate 10 days after discharge (Ducharme and Kramer 1993). The relapse rate at the 2-week post ED interview significame increased with asthma severity; of interest will be whether this trend is observed in results from the 6—month follow-up interview. 83 The NAEPP Guidelines advocate ICS for persistent asthma and oral steroids for patients upon discharge from the ED after an acute asthma attack (NAEPP 1997). A rewnt meta-analysis examined whether prescribing inhaled corticosteroids at discharge would reduce the likelihood of return visits to the ED for acute asthma (Edmonds et al. 2003). Three random clinical trials were included in this meta-analysis, involving a total of 909 patients (ages 12—60), and compared the treatment at discharge of ICS plus oral corticosteroids (00) with 00 alone (Edmonds et al. 2003). Although there was a m in favor of ICS, the difference in relapse after ED discharge was not significant at 7—10 day follow-up (odds ratio (OR)= 0.72; 95% CI, 0.48—1.10) nor at 20-24 day follow-up (OR=0.68; 95% CI, 0.46—1.02). Another meta-analysis of seven random clinical trials of patients (four of children, three of adults) discharged after an ED visit for acute asthma compared post ED prescription of ICS versus OC (Edmonds et al. 2003). Again, no significant diffemnces between treatments were found in asthma relapse at either 7—1 0 day (OR=1.0; 95%Cl, 0.66-1.52) or 16—21 day follow-up (OR=1.26; 95% Cl, 0.80— 1.99). The findings were deemed inconclusive as all seven studies excluded patients with severe asthma, the sample sizes were considered inadequate to prove equivalence between the treatments, and there was heterogeneity among the studies in several secondary outcomes (B-agonist use, symptoms, and quality of life). One study that did show a positive result, a random clinical trial that was included in the three trial meta-analysis, demonstrated a 48% reduction in asthma relapse after discharge for the ICS group (12.8%) compared with the identical placebo (24.5%) (Rowe et al. 1999). More research is required to explore whether ICS added to OC at discharge clearly benefits patients and whether a higher dose of ICS, as was used in the Rowe trial, 84 might prove more beneficial than the lower doses reported in the other two studies. Further investigation should also include trials involving young children, as none of the above mentioned trials involved participants younger than 12 years. Adherence to the NAEPP Guidelines: the gold standard? While the Guidelines have been promoted as the standard in asthma treatment and management, it remains to be seen whether adhering to the recommendations will improve asthma-related outcomes. Evidence has been inconsistent in showing that variations in asthma care and home management correspond with changes in health care services, mortality rates, or reduced morbidity (Crain et al. 1995). The Guidelines have been formulated by a panel of asthma specialists backed primarily by an extensive literature review and evidence from existing clinical trials. However, the Guidelines have shilted attention from traditional medical treatment to a broader scope of asthma management that emphasizes a greater role of the patient in controlling their disease. With an increased role for patients in monitoring their disease, concern arises as to whether they will be able to sustain the level of compliance necessary to keep their asthma in check, e.g., taking PEF measurements several times a day, keeping track of how much medication they are taking and when, especially children. Patients need to be able to recognize when in the course of their disease they may step-down or step-up certain components of their plan. It is critical for their well-being that patients work along with their care providers to appropriately monitor and manage their disease. In absence of any other gold standard, the NAEPP Guidelines offer a standard for consistency or asthma care and treatment The establishment of these recommendations has provided a scientific basis on which to form testable hypotheses 85 for additional research that will perhaps delineate which components of the asthma management programs are essential as well as time- and cost-effective (Meijer et al. 1997). This study is the first to our knowledge to compare self-reported asthma patient care and management with key NAEPP recommendations in Michigan. Consequeme it is not possible to gauge whether there has bwn an improvement in these measures in the study population since the inception of the NAEPP Guidelines. However, comparison of our study with similar studies of ED patients suggests that there has been some progress in several measures of NAEPP recommendations in patient care. In particular, we note the more widespread use of ICS and possession of peak flow meters as well as the report of asthma education among the Butterworth patients. Not all recommendations, however, show evidence of integration into asthma care practices within the local asthma medical community. Notably, the majority of these children had not been given an action asthma plan. Several measures are expected to be dependent upon the level of chronic severity. However, patients with severe asthma did not have significantly more checkups in the past year than patients with mild disease, although three quarters of patients with moderate persistent asthma indicated that they had made at least two regular checkups. Apart from a diffemnce between mild intermittent and severe patients, we did not detect a significant trend among the Butterworth patients in ownership of a PFM based on their severity, despite the fact that long-term monitoring with a PFM is recommended for patients who have moderate to severe persistent asthma. The increasing use of ICS with asthma severity (Table 138) suggests that ICS are being 86 prescribed in accordance with the NAEPP Guidelines. One third of mild intermittent asthma patients were also taking ICS, but we have no way of knowing whether these patients were prescribed medications inappropriate for mild asthma symptoms or their level of severity is indicative of controlled asthma. Patients at discharge were instructed by the ED staff to see their RACP for follow- up. Failure on the part of the patients to do so did not appear related to patient asthma severity. ltisnotknownwhetlerparentsdidnotcompretendtheinportanceof obtaining follow-up medical attention for their child or other reasons prevailed for not making the post-ED RACP appointment, as previously discussed. Despite some progress towards following the NAEPP recommendations compared with the older ED studies we have reviewed, the data from our study reveal several gaps in the continuity of care reportedly mceived by the Butterworth ED patients and in the ability of patients and parents of children with asthma to self-manage their disease. These shortcomings do not appear to be related to patient baniers to access to care, as almost all of these patients said they had health care coverage and a RACP. Two explanations for these gaps exist failure of the RACP/regular asthma care program to fully educate the patient and family with respect to the tools, information, and self- management skills required to manage asthma as a chronic disease; and (or) inability of patients to adhere to their asthma management program. Barriers to adherence may lie not only with the parent’s lack of understanding of what is expected in terms of providing optimal asthma care for their childmn, but also in the failure on the part of RACPs to accept or incorporate the recommendations into their practice and (or) in the 87 quality of the asthma care and education delivered to the patients by their provider (Leickly et al. 1998). We have seen that while most primary care physicians have read the NAEPP Guidelines, integrating the recommendations into their clinical practice has not been universal or immediate. There are probably many obstacles to doing so of which we are unaware. Managing a chronic disease requires continual maintenance and problem-solving skills that many pamnts, especially young parents, may feel ill-equipped to handle. lmparting such skills to parents and people coping with asthma is part of a collaborative care partnership with primary care physicians that fosters in patients the knowledge, ability, and confidence to effectively cope with their disease (Bodenheimer et al. 2002). Limitations of the study Low enrollment changed the planned analysis for this cohort. _While the resulting sample size is sufficient for overall measures of proportions, it limits subgroup analyses and what can be concluded from a number of parameters in this analysis. For example, with a larger sample (and smaller confidence interval), we would feel more certain that 9.4% truly represented that proportion of children reporting the use of LABA An additional NAEPP recommendation addresses the control of allergens that trigger asthma exacerbation. Our study did not collect lnfonnation on asthma triggers or environmental allergens, e.g., no data on smoking in the house. Additional lnfonnation on asthma triggers and allergies might shed light on the distribution of asthma symptoms and the transient nature of chronic severity. 88 Because patient recall tends to diminish over time, accounts of events beyond a 2- to 4-mek recall period may not be accurate (NAEPP 1997). It was not possible to confirm information provided by patients about hospital utilization and medical appointments in the past year. Lack of parental report of an item is not necessarily the resultofpoorparental recall, butmaybeduetothedoctornothavingperfonnedit (Dinkevich et al. 1998). Pamnts or guardians with whom the interviews were conducted may not have been the child’s primary camgiver, and consequently they may not have first-hand knowledge of the child’s asthma. No information was collected about the dose of ICS the children were taking in the 4 weeks prior to the ED visit This information would have helped to determine adherence to NAEPP Guidelines with respect to severity. The possibility exists for incorrect classification of medications patients were taking. We do knowthat at least one ring may have been incorrectly coded, e.g., there are two pmparations of Proventil (albuterol), one is for extended release, i.e., a long-acting (3— agonist, and it is also sold as a quidt-relief inhalation medication. Thme children reported taking Proventil and were classified as taking a short-acting B-agonist, but it is not possible to know which version of Proventil they were taking. Finally, without a control group, we do not know how representative the findings ofthiscohortstudyareofall childrenwithasthmawhopresentatEDsoratotherurgent care centers. In an emergency department setting, finding an inherent control group for a study investigating aspects of asthma care and management would be problematic, andinfact,hasnotbeendonetoourknowledgeinotherED-basedstudies.'l'he conclusions about our results are certainly applicable to patients with primary care 89 access who use the ED and provide new lnfonnation that will be useful in future research endeavors. Conclusions and future directions This study establishes a baseline characterization of pediatric asthma patients who utilize emergency services for asthma treatment in the Grand Rapids area. The results presented provide region-specific data on aspects of primary care patient self- management for asthma that could be used for the development of educational programs or interventions targeted to reduce gaps or fill voids in the delivery of asthma care and management information. The following are suggested for future action: 1. Advocate the necessity of asthma action plans for all asthma patients among managed care organizations and primary care physicians. Promote among physicians the need to develop the plans with the patients, provide education about aspects of the plan, aid periodically review with patients what steps to follow when they experience an asthma attack 2. Increase RACP awareness of patients asthma severity through increased contact (frequent asthma care visits, telephone assistance). Techniques, such as the use of diary cards by patients, may capture more relevant symptom data useful in determining asthma severity. To promote continuity of care, it may be helpful to schedule the next visitatthe time ofthe present one. 3. Link an ED visit with a follow-up RACP visit. As research has shown that patients are more likely to attend follow-up appointments when they are made before the patient has left the ED, exploring ways to accomplish this are recommended. Barriers to booking follow-up appointments for patients include possible lack of ED staff for this function and 90 inability to contact primary care oflices duing evening, nighttime and weekends. One method to circumvent this problem might be to electronically contact the patients primary care provider to prompt the PCP office to make an appointment with the patient. 4. Foster a collaborative care partnership among RACP, asthma specialist, and patient to facilitate asthma care. 5. Promote awareness among primary asthma care physicians that combination literary oflCSand LABAisnowrecommendedformoderatetosevereasthmapatients. 6. Survey primary care health professionals in the Grand Rapids area to assess local level of knowledge of the NAEPP Guidelines and updates, to determine any baniers in delivering the recommended care and asthma education, and to investigate under what circumstances physicians refer asthma patients to asthma specialists. 7. Future studies should include questions about allergies and environmental triggers of asthma. 8. Further research in children is required to explore whether prescription of ICS at discharge from me ED may reduce the incidence of asthma relapse. 9. Design an epidemiological cohort study to investigate whether adherence to the NAEPP recommendations results in improved asthma-related outcomes, sudi as timely follow-up visits, fewer hospitalizations, ED and urgent visits, regularly scheduled asthma care, and appropriate use of asthma medication for the patients level of chronic severity. A baseline evaluation of asthma patients at primary care clinics would identify those patients who follow the recommendations (exposed group) and those who do not (control group). Of interest would be to identify which recommendations have a stronger influence than others on the outcomes. 91 Bibliography Akinbami LJ, and KC Schoendorf. 2002. 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