A CLINICAL PROTOCOL FOR THE ADVANCED _ ASSESSMENT OF FEET IN INDIVIDUALS WITH ; DIABETES MELLIIUS IN PRIMARY CARE SETTINGS Scholarly PTDjeCI for the Degree of M S ' MICHIGAN STATE UNIVERSITY BETH A AMMERMAN 1996 LlBRARY T Michigan State University 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 6/01 c:/CIRC/DateDue.p65-p.15 A Clinical Protocol For The Advanced Assessment Of Feet In Individuals With Diabetes Mellitus In Primary Care Settings by Beth A. Ammerman A Scholarly Project Submitted to: Michigan State University College of Nursing in partial fiilfillment of the requirements for the degree of Master in Science 1 996 Acknowledgements I would like to thank the members of my committee who devoted the time and special efl‘orts to help me achieve my final product. I really appreciated all they have done for me. Thank you Rachel Schifinan, Sharon King and Brigid Warren. Table of Contents The Problem Introduction ............................................................................................ 1 Conceptual Framework ........................................................................... 3 Starfield's Model ......................................................................... 3 Starfield's model as Applied to Diabetes Mellitus ......................... 6 Structure .......................................................................... 6 Process ............................................................................ 8 Outcome .......................................................................... 8 Review of Literature ............................................................................... 9 Pathogenesis of Diabetes Mellitus ............................................... 9 Pathogenesis of Diabetic Neuropathy .......................................... 10 Pathogenesis of Peripheral Vascular Disease ............................... 14 Pathogenesis of Infection as Related to PVD and Polyneuropathy. 15 Studies Identifying Need for Assessment of Feet in Diabetes ....... 16 Project Development ......................................................................................... 17 Assessment Protocol / Structure ............................................................ 17 Health History ........................................................................... 19 Physical Examination ................................................................. 22 Testing ...................................................................................... 24 Process ................................................................................................. 25 Target Group ............................................................................ 25 Time ........................................................................................ 26 Cost .......................................................................................... 26 Outcomes ............................................................................................. 27 Implications for Advanced Nursing Practice .......................................... 28 References ............................................................................................ 30 Appendix .............................................................................................. 3 5 . FOO'I' ASSESSMENT 1 A Clinical Protocol for the Advanced Assessment of Feet in Individuals with Diabetes Mellitus in Primary Care Settings Introduction Diabetes mellitus is a disease of metabolic dysregulation, particularly abnormal glucose metabolism, accompanied by long term complications (Upheld & Graham, 1994). Others have noted that diabetes is "not a discrete disease but ratherrepresents a range of clinical syndromes associated with high blood glucose" (O'Connor, 1994, p. 11). Diabetes mellitus and its complications represent one of the most prevalent conditions seen in primary care. It afi‘ects approximately sixteen million Americans and direct costs of diabetes mellitus top over forty five billion dollars each year (National Institutes of Health [NIH], 1995). There is an additional cost of approximately forty seven billion dollars attributable to diabetes indirectly through disability, work loss, and premature mortality (NIH, 1995). Of those people newly diagnosed with diabetes each year, approximately 595,000 are classified as non-insulin dependent diabetes mellitus (NIDDM) or type II and 30,000 are classified as insulin dependent diabetes mellitus (IDDM) or type I (NIH, 1995). Patients with either type I or type II diabetes are susceptible to developing complications of diabetes. Common complications of diabetes mellitus include retinopathy, nephropathy, hypertension, cardiovascular disease, peripheral vascular disease (PVD) and neuropathy. Diabetic foot problems are the most common complication of diabetes leading to hospitalization (Gibbons & Eliopolos, 1984). Approximately 54,000 diabetic patients undergo lower limb amputations each year due to complications of diabetes (Center for Disease Control, 1995). It is said that over half of the amputations performed on patients with diabetes could be avoided by preventive education and early intervention (American Diabetes Association [ADA], 1993). It is also said that these amputations could be lowered by reducing risk factors like cigarette smoking, hypertension, and high FOOT ASSESSMENT 2 blood sugar (U .S. Department of Health and Human Services, 1990). Often chronic complications develop gradually in diabetes, making it dificult for those affected to notice changes. Because complications often encompass subtle changes over many years, they may be overlooked by the patients themselves, as well as the providers. Advanced practice nurses (APNs) have been providing primary care to a wide variety of patients, including those with diabetes. The Diabetes Control and Complications Trial (DCCT) afiirmed the importance of the nurse's role in the management of diabetic patients (DCCT Research Group, 1993). Currently, APNs contribute significantly to the delivery of health care by decreasing costs associated with hospitalization and interventions (F 0rd, 1992; Koch, Pazaki, & Campbell, 1992). The current trends in health care include illness prevention and providing the most comprehensive care for the lowest cost. The DCCT (1993) recognized that while tight glucose control helped to prevent and slow the progression of diabetic complications, tight glucose control was also nearly twice as expensive as conventional diabetic treatment. The ADA agreed that tight glucose control was expensive, but stressed the long term benefits including improved quality of life, fewer sick days, fewer amputations and fewer complications would offset the high cost of tight control in the long run (ADA, 1993). The dilemma for primary care providers is how to adequately manage the diabetic patient given the time factors, available resources and equipment, as well the cost of health care, especially in managed care settings. The American Diabetes Association (ADA) set forth a guideline of standards of care for patients with diabetes mellitus in 1988. These guidelines were revised in 1994 and offer criteria for assessment and treatment of diabetes in primary care. See Appendix. Kerr (1995) challenged the guidelines and noted that the ADA standards were "impractical in the usual busy office setting, where it is common for new patients to be allotted visits of only 20 to 30 minutes and established patients to be allotted visits of 10 to 15 minutes" (p.63). Kerr also noted that "the recommendations were based on expert consensus rather FOO‘I' ASSESSMENT 3 than a formal analysis of the published medical literature” and that there has been " no published evidence of any impact of these standards on physician practice or diabetes mortality" (p.63). Studies have shown that physicians and APNs have not consistently followed the guidelines of the ADA. As primary care APNs, it is critical that ongoing assessment of patients with diabetes take place to screen for and monitor complications. Accurate routine assessment of patients with diabetes may alert APN health care providers to any changes and impending complications that the patient with diabetes may be experiencing, including foot problems. Although the ADA guidelines claim to be applicable to primary care, they are more focused for those providers in diabetic specialty practice as they are very comprehensive and time consuming. There is clearly a need for revised diabetic care guidelines that are user - fiiendly and applicable to primary care. There is a specific primary care need for an assessment tool for foot status of diabetic patients that is comprehensive, practical to primary care and clinically time efiicient. This project focused on complications associated with foot problems in diabetes, mainly neuropathy and vascular disease. Therefore the purpose of this scholarly project was to develop a protocol for use in primary care settings by nurses in advanced practice specifically to assess the feet of patients with diabetes during routine physical exams. Since the focus setting was primary care offices, the protocol was be placed into the framework of primary care by Barbara Starfield. Conceptual Framework Starfield's Model Primary care is the delivery of comprehensive, long term health care regardless of the presence or absence of disease. Health care providers in primary care act as the gatekeeper for referrals, coordinate services and act as the health team leader. The characteristics of primary care include longitudinality, first - contact, integration of services and comprehensiveness (Alpert & Chamey, 1973; Parker, 1974). Starfield (1992) identified four factors which determine the state of health in an individual which STRUCTURE PROCESS< OUTCOME Provision of Receipt of FOOT ASSESSMENT 4 Personnel Facilities and Equipment Range of Services Organization Management and Amenities Continuity Awessibility Financing Population eligible l' Problem recognition Diagnosis Management Reassessment PERSONS Utilimtion Acceptance and Satisfaction Understanding Participation ' Social and Physical environment Longevity Activity Comfort Perceived well - being Disease Achievement Resilience FIGURE 1. The health services system. Source: Starfield, 1973. FOOT ASSESSMENT 5 include genetic structure, social and physical environment, individual behaviors, and health services (medical practice). Of these four factors, Starfield's fiamework focused specifically on health systems and evaluating primary care. Starfield's framework for evaluation of primary care (see figure 1) focuses on the health service system and its components of: structure (resources needed to provide services), process (how implemented) and outcome (the impact of the implemented health system). The structure of the health care system includes the resources needed for health care delivery and includes personnel, facilities and equipment, range of services, organization, management and amenities, continuity, accessibility, financing, and the eligible population (Starfield, 1992). The process of health service is two-fold and includes activity on part of both the provider and the patient. The provider is responsible for the problem recognition, diagnosis, treatment and reassessment of the problem (Starfield, 1992). This is very similar to the nursing process of assessment, diagnosis, plan, treatment, and evaluate. The patient is responsible for deciding whether or not to use the system, understanding what providers offer them, deciding whether or not to accept what the provider has to ofi‘er and evaluating how satisfied they are with the care. It is up to the patient to follow the advice of the primary care provider, modify it as the patient sees fit or disregard the advice (Starfield, 1992). The outcome of care in the health system is conceptualized by Starfield as having seven major components including longevity (life expectancy / mortality), activity of the individual, comfort of the individual, perceived well-being and satisfaction of the individual's health, disease (mental and / or physiological), achievement (level of development / how normal social roles are performed) and resilience (ability to cope with adversity and potential for resisting threats to health) (Starfield, 1992). FOOT ASSESSMENT 6 W The structure, process, and outcome are the basis for the primary care framework. Starfield used these elements to evaluate primary care goal attainment. Starfield's model was chosen for evaluation of diabetic patients in primary care because this fiarnework clearly evaluates outcomes as related to both process and structure. Within this fiamework the care of the patient with diabetes and the goal of reducing diabetic foot complications can be evaluated. Structure The patient enters the system through the structure of primary care (see figure 2). The ofiice must be accessible and user fiiendly. This includes ease in obtaining appointments and flexible hours and days the ofice is open. Also the building must be accessible for those patients with foot complications often found in wheelchairs or on crutches. The parking lot should ofi‘er spaces available close to the doors or a drop-off area to increase accessibility for patients with foot complications. Included in the structure, the personnel is also a key component. At the reception area, courtesy is greatly needed by those first contacting the patient. Often in primary care it is necessary for a patient to see more than one primary care provider. Even if the patient regularly sees one provider, often it is necessary to occasionally see a different provider. For this reason good communication must exist within the personnel. Knowledgeable personnel is of extreme importance. The receptionists must be knowledgeable in triaging appointments, those which require rapid appointments and those which can wait for a day or two. The medical assistants must be knowledgeable when obtaining information fiom the patients and when answering calls from patients with questions. The providers must be knowledgeable about the patient's case, as well as the most current research and therapies dealing with diabetes and foot complications. STRUCTURE PROCESS Q / Provision of Care Receipt of OUTCOME FOOT ASSESSMENT 7 Personnel - Primary care providers including APNs Facilities and Equipment -Primary care ofiice -Testing equipment: cotton wisp, pin. small water bottles with water of varying temperatures, and monofilament Range ofServices - Diabetic assessment in addition to other primary eare services Organization - Team approach with APN and Physician Management and Amenities Continuity of Care and Coordination of team services Awessibility Financing . Population eligible - all diabetics within the practice l' Problem recognition - Assessment of foot status among patients with diabetes and identification of real or potential foot problems Diagnosis - of foot status Management - treatment of real foot problems, education of potential foot problems and prevention, education of treatments and tests prescribed Reassessment - Continuity of Care PERSONS Utilization - Interaction with primary care providers Acceptance and Satisfaction - keeping appointments, following prescribed activities Understanding - why a treatment / test is prescribed Participation - reqronsibility for own care ' Longevity - goal: normal life expectancy Activity - ambulation potential, functional or disabled goal: to maintain function Comfort - goal: pain relief or pain control Social and Physical envrro' nment Perceived well - being - goal: satisfied vs. dissatisfied Disease - State of diabetes goal : prevent and control foot complications including amputations Achievement - moving towards goals Resilience - decrease vulnerability to complications Fig. 2. Modified from Starfield, B. (1973). The health services system. FOOT ASSESSMENT 8 The financing is yet one more way to increase availability. Health concerns must be first, although financial concerns are also very important. Setting up payment plans for work done is one way to increase accessibility. Process The process (see figure 2) consists of input by both the health care provider and by the patient. For the attainment of primary care both the patient and the provider must recognize the need for continuity. The provider must recognize the importance of foot status, the impact of diabetic foot complications, and the importance of proper foot assessment. It is important that the provider inform the patient of possible complications of diabetes and of the need for ongoing assessment. In addition, the provider must also educate patients in the importance of good foot care and emphasize self care to the patient. The provider must recognize the need for continuity of care and encourage regular visits (at least bi-anually) for foot assessment. The patient also must have input into the process of foot assessment. It is up to the patient to decide whether or not to utilize the system and accept or refuse the suggestions of the provider. Keeping appointments, following treatments prescribed and asking questions are all integral parts of the patient input of the process. In the care of diabetic patients, compliance is a key issue and patient outcomes are related to self-care. Outcome Outcomes of diabetic foot assessment protocol include longevity and morbidity / disease, level of firnction with activities of daily living (ADLs), comfort, perceived well - being, resilience to complications, and achievement of goals. Longevity and morbidity refers to the illness and death rates among diabetic patients in the practice. Basically it is the number of patients sufi‘ering from illness or severe foot complications. The level of function in regards to ADLs refers to abilities of a person to work, shop, cook, clean, bathe, dress and care for oneself. Comfort reflects how comfortable a patient is in regards to pain and sensation (numbness, tingling, burning, aching). Perceived well-being FOOT ASSESSMENT 9 indicates how a patient feels he or she is coping and functioning and the degree of illness perceived by the patient. The outcomes can be measured by chart review, measuring morbidity, comparing laboratory values, number of diabetic patients in the practice hospitalized with foot complications, patient satisfaction, and patient knowledge level. In this way, the outcomes can be evaluated on a regular basis and a system of internal checks and balances can arise. By internal monitoring of the system, continuous quality improvement (CQI) may achieved. It has been noted that while diabetic neuropathy and ischemia are not completely avoidable, they may be influenced by tight glucose control. For this reason, the ongoing assessment of patients with diabetes is crucial. In assessing the status of patients with diabetes it is important to screen for complications and to reassess any known complications. The development of the protocol for assessment of feet of individuals with diabetes is best represented by the structure - process - outcome model. Review of Literature The literature reviewed included the pathogenesis of diabetes mellitus, pathogenesis of diabetic neuropathy, pathogenesis of peripheral vascular disease, pathogenesis of infection related to diabetes mellitus and studies performed identifying the need for foot assessment of patients with diabetes in primary care. Pathogenesis of Digges Mellitus Diabetes mellitus is a syndrome that has been associated with hyperglycemia (O'Connor, 1994) and alterations in metabolism of fat, protein and carbohydrates (McCance & Huether, 1991). There are two main types of diabetes mellitus, type I (IDDM) and type II (NIDDM). Type I is characterized as acute onset, generally affecting individuals under the age of thirty years with peak onset around puberty (ages 11-14 years) with a higher prevalence in Caucasian individuals (O'Connor, 1994; McCance & Huether, 1991). Type I is also referred to as insulin dependent diabetes mellitus (IDDM) as those type I individuals are prone to diabetic ketoacidosis. It is unknown exactly how FOO'I' ASSESSMENT 10 type I diabetes develops but it is thought that it is a genetic predisposition triggered by environmental factors such as viruses, drugs (pentamidine) and milk protein (O'Connor, 1994). The pathophysiology of type I is characterized by the destruction of beta cells in the islets, resulting in lack of insulin, excess glucagon and the inability to properly metabolize fat, protein and carbohydrates (McCance & Huether, 1991). Type II diabetes mellitus, or non-insulin dependent diabetes meillitus (NIDDM), difi‘ers fi'om type I in many ways. Those afi‘ected are generally diagnosed alter the age of 35 years, the incidence of NIDDM increases with age, is associated with obesity and is more prevalent in minorities (O'Connor, 1994). The mechanism for action is thought to be a genetic predisposition, plus a trigger of obesity, stress, aging, inactivity, certain medications or other disease. It is hallmarked by a resistance of fat, muscle and liver cells to the action of insulin. It is called non-insulin dependent because those individuals affected by type II are not prone to diabetic ketoacidosis. Whereas there are no beta cells present in established type I individuals, the beta cells in those with type H are present but decreased in number and size (McCance & Huether, 1991). As diabetes afi‘ects the metabolism of the entire human body, it also has a direct efi'ect on the feet as it predisposes feet to tissue damage. Three factors which predispose the diabetic foot to tissue damage include diabetic polyneuropathy, PVD, and infection (Caputo, Cavanagh, Ulbrecht, Gibbons & Karchmer, 1994). Pathogmesis of magic Ngggpgthy Diabetic neuropathy is a well studied yet poorly understood complication of diabetes. It has been noted as "not a single entity but a diverse group of disorders exhibiting a wide range of natural histories and clinical manifestations” (Kahn, 1992). Diabetic neuropathy incorporates a variety of disturbances in the peripheral nerve firnction. The pathology may be vascular, metabolic or both. There are many types of neuropathy, including reversible neuropathies, established focal and-multifocal neuropathies and established symmetric neuropathies, which includes diabetic symmetrical FOO'I' ASSESSMENT 1 l distal sensory and motor polyneuropathy. The focus of this project was on diabetic symmetrical distal sensory and motor polyneuropathy, also known as diabetic polyneuropathy. Diabetic polyneuropathy is the most common form of neuropathy (ADA, 1995; Kozak & Guirini, 1995; Thomas, 1994). Nerve damage begins early in the course of diabetes and progressively worsens over time, until becoming clinically evident (ADA 1995). The neurological deficit is peripheral, and involves the distal sensorimotor fibers in a glove and stocking distribution (Kozak, Rowbotharn & Gibbons, 1995). The symptoms of diabetic polyneuropathy include numbness, tingling, burning, and needles and pins type pain, especially at night and relieved often by walking (Gerding, Piziak & Rowbotham, 1991). Common pain sensations include feelings of burning feet, cold feet, feet encased in concrete, like walking on glass, knife-like shoot pains up the legs. These sensations are usually not related to anything and usually occur in bilateral lower limbs. It may afl‘ect any individual with diabetes but is generally more common in type I rather than type II, in men more than in women, and in diabetes of long duration more than recent onset. There are firrther classifications of diabetic neuropathy including small and large fiber involvement, which account for the difi‘erence in symptoms of people amicted with the same complication. Small fiber neuropathy is more often an early complication occurring after only a few years of elevated blood glucose, while large fiber neuropathy usually occurs later in the disease. Small fiber neuropathy is characterized by deep, bunting, twisting, aching, pins and needles distal pain while larger fiber neuropathy is often painless (Greene & Pfeifer, 1985). The pain felt with small fiber neuropathy is alien superficial where light touch to the affected area is more painfirl than deep pressure (Thomas & Brown, 1987). Large fiber neuropathy often is hallmarked by impaired balance and loss of tendon jerks, while in small fiber neuropathy afflicted patients maintain their balance and tendon reflexes (Thomas & Brown, 1987). Those affected by large fiber FOOT ASSESSMENT 12 disease generally have decreased vibratory sensation while those with small fiber disease usually maintain vibratory sense but experience impairment of temperature (ADA, 1995). The pathology of diabetic polyneuropathy is unclear, although it has become evident that there are both metabolic and vascular components involved (Thomas, 1994). While there has not been a cause identified, it has become evident through years of research that the cause may actually be a conglomeration of vascular and metabolic changes brought on by increased blood glucose levels. Metabolic theory is based on hyperglycemia or some related abnormality as the triggering factor for tissue damage. The polyol pathway theory is currently the most popular (Thomas, 1994). Cells of the brain, aorta, red blood cells, lens and peripheral nerves (Schwann cells) do not depend on insan for entry of glucose. These cells rely on the polyol pathway for metabolism of glucose. Metabolism of glucose within these cells consists of two enzymatic steps including the reduction of glucose to a polyol called sorbitol (by means of the enzyme aldose reductase) and then the reduction of sorbitol to fi'uctose (by means of the enzyme sorbitol dehydrogenase). Cytoplasmic levels of glucose within the cells reflect the degree of glycemia of the body. In normoglycemic states, the sorbitol concentration within the nerve cells are low. Hyperglycenric states increase the concentration of glucose in the peripheral nerve and lead to increased activity of aldose reductase thereby increasing the concentrations of both sorbitol and fi'uctose. In studies of diabetic animals, the increased concentrations of sorbitol and fructose occur in conjunction with decreased concentrations of myoinositol, another polyol. Myoinositol is a normal constituent of plasma and cells, and is needed for maintenance and firnctioning of axonal membranes (Pozza, Librenti, Comi & Canal, 1985). Myoinostol concentrations are higher in the peripheral nerve than in the plasma during norrnoglycemic states. The method for cellular uptake is the active transport mediated by sodium - potassium. In hyperglycemic states, the levels of myoinositol in the nerve fibers fall due to increased activity of sodium dependent active transport out of the cell and the efi‘ects of FOO‘I' ASSESSMENT 13 increased glucose concentrations on renal tubule absorption of myoinositol which results in increased urinary excretion of myoinositol (Thomas, 1994). The exact cause for development of diabetic neuropathy is unknown but several theories exist which may explain it. The metabolic theories speculate that the cause is linked to either the accumulation of sorbitol or the lack of myoinositol. It has been theorized that since sorbitol lacks cell membrane permeability, an accumulation may cause a toxic efl‘ect resulting in de-myelination, defective myelin production, altered cellular function, and imparied velocity of peripheral nerve conduction (Kozak, Rowbotharn & Gibbons, 1995; Pozza, Librenti, Comi & Canal, 1985). The accumulation of fi'uctose may also be linked to the development of neuropathy as it passes into the endoneural space and may induce hypertonicity thereby causing axon shrinkage (Pozza et al., 1985). Another metabolic theory postulates that excess blood glucose in hyperglycemic states competes with the myoinositol for entrance into the peripheral nerve cell, causing a drop in the cell's myoinositol levels causing it to pump out sodium, which in turn slows down nerve impulses to the muscles and organs. Also it has been suggested that neuropathy may be due to axonal injury (instead of Schwann cell) which triggers glucose and / or sorbitol to decrease the concentration of nerve tissue myoinositol resulting in nerve dysfunction (Olefsky & Sherwin, 1985). These theories are supported by the modest improvement in nerve conduction seen with the administration of aldose reductase inhibitors (Alrestatin and Sorbinil) and dietary supplements of myoinositol in animals. The weaknesses of the theories include that the studies done used diabetic rats and rabbits which have been found to differ fi'om humans in many manifestations of diabetic complications. The other main theory to explain diabetic neuropathy is the vascular theory, which proposes neuropathy is a result of development of microangiopathy. The walls of the vessels supplying blood to the nerves (vasa nervorum) begin to thicken and may occlude the vessels, resulting in a slowing or complete cessation of the blood flow to the nerves. This theory is supported by the recovery of nerve feeling that is seen in after recanalization FOOT ASSESSMENT 14 of blood vessels. The weakness is in the fact that often nuerOpathy occurs without PVD, and it would be unlikely that only the vasa nervorum would experience occlusion. The clinical signs of polyneuropathy seen include a foot that is well nourished with hair, high arches, good post tibial and dorsalis pedis pulses, cocked up hammer toes, possible calluses, and disproportionate muscle tone (Campbell, Freeman & Kozak, 1995). Sensation, vibration sense and Achilles tendon reflex may be decreased or absent. Foot drop may be present in advanced cases. Also present may be Charcots deformities or superimposed infections (ulcers, osteomyelitis), which are often complications of polyneuropathy. Charcots disease is characterized by a wide, deformed foot with short toes, collapsed arches, and deformed joints (Edmonds & Foster, 1994). It begins with neuro-osteoarthropathic changes in the foot accompanied by joint swelling with bone disruption and fiactures, which eventually heals with bone deposits and leaves the joints disrupted (Campbell, Freeman & Kozak, 1995; Edmonds & Foster, 1994; ). Pathogenesis of Peripheral VMar Disease. Diabetic Peripheral Vascular Disease (PVD) is another cause of foot complications in patients with diabetes. In diabetics, PVD develops at an earlier age than the general population and is twenty times more common in diabetics than in the general population (Gerding, Piziak & Rowbotham, 1991). Vascular complications in diabetes have been thought to be linked with alterations in platelet and / or endothelial function. These alterations have been thought to precede clinical manifestations of vascular disease and include increased platelet aggregation, decreased platelet survival, and diminished fibrinolytic activity among others (Gerding, Piziak, & Rowbotham, 1991; Olefsky & Sherwin, 1985). These alterations have been known to be responsive to intensive glucose control although it is not clear if these changes are directly realted to poor glucose control. The pathogenesis of PVD is more clear cut than that of neuropathy. Vessels feeding the nerve become occluded with thrombi, starving the nerve of oxygen and causing the nerve to malfunction. This causes vascular problems as the flow of blood is FOOT ASSESSMENT 15 decreased to the foot. In addition there is an increase of low density lipoprotein cholesterol and an increase in platelet adhesiveness to the vessel walls which causes an increase in plaque production resulting in occlusion of the vessels (Gerding , Piziak, & Rowbotham, 1991). The symptoms of PVD include pain on exertion (with exercise), cold feet, thin or atrophied skin, and lack of hair on the lower extremities (Campbell et al., 1995). The feet may become discolored and edematous when dependent. Pulses will be diminished or lacking. A decrease in the ankle - brachial index (ABI) is also indicative of PVD. Complications include ulcers, gangrene, amputations, thrombophlebitis, cerebrovascular accidents (CVA) myocardial infarction (MI), and death. P i f Inf ion R 1 P P 1 Individuals with diabetes are especially at risk for the development of foot infections due to other complications like polyneuropathy and PVD. Most patients with long standing diabetes will have both neuropathic and ischemic changes, which will compound the risk of developing infection (Gerding, Piziak, & Rowbotham, 1991). With polyneuropathy, the normal sensation in the foot is dulled or absent making the patient more susceptible to injury. With the altered sensation an ill fitting shoe can cause excess friction without the patient's knowledge, forming a callus over a pressure point. Hyperglycemia causes glycosylation of collagen which makes the callus become rigid and causes further injury to the foot. Infections in the feet of diabetic patients often begin as calluses. With PVD, when the patient endures a trauma to the foot, the decreased circulation causes decreased oxygenation to the tissues and thus prevents timely healing fiom occurring and allows for the microorganisms to grow. In addition, patients with diabetes have increased glucose in body tissues which provides an excellent source of energy for the proliferation of pathogens. The decreased blood supply also results in a FOOT ASSESSMENT 16 decrease in the supply of white blood cells transported to the afi‘ected area which are needed to fight ofi‘ the pathogens (McCance & Huether, 1991). The symptoms and clinical signs of infection include a red, warm foot, ofien with open ulcers and / or edema. Pulses are usually present but may not be if the cause of infection is PVD. The foot is generally painful, unless it is neuropathic. Body temperature may be elevated as will white blood cell count. In severe cases loss of glucose control, shaking chills, and high fever may be present (Campbell et al., 1995). The complications of infection include localized ulcers and gangrene, lower limb amputations, systemic sepsis, and death (ADA, 1993). tudi Ien" N for m fF inDi et The importance of proper assessment of individuals with diabetes is well documented. Studies have shown that there is a need for better assessment and management of patients with diabetes by both physicians and nurse practitioners. Wylie- Rossett, Walker, Shamoon, Engel, Basch and Zybert (1995) reported that populations at risk of diabetic complications were unlikely to have foot examinations done by their primary care providers in New York. Payne, Gabella, Michael, Young, Pickard, Hofeldt, F an, Stromberg and Hamman (1989) reported similar findings in that only halfof the diabetic patients in Denver inner-city clinics received foot examinations by their primary care providers over a one year period. Fain & Melkus (1994) noted that in a study of six nurse practitioners (NPs), foot examinations were documented in only 23 % of the charts reviewed and that the ADA guidelines for the care of patients with diabetes were not consistently being followed. Stolar (1995) found that endocrine fellows at 42 academic institutions also were deficient in upholding the ADA's guidelines including those concerning foot assessment. Kenny, Smith, Goldschmid, Newman and Herman (1993) reported that physicians were deficient in following the ADA guidelines but self-reporting of adherence was markedly high. FOOT ASSESSMENT 17 The studies done show a significant need for better assessment of feet in primary care. However the Fain & Melkus study was weak in that it used low numbers (only 6 NPs) and only at one location, while Stolar‘s study used forty two locations and many more providers were studied. The studies which used chart reviews (Kenny et al., Fain & Melkus) may be more limited than those which used patient reporting in that charting is not uniformly performed by all providers. The ADA (1991, 1994) and the Centers for Disease Control and Prevention ( 1991) have recommended primary care provider examination of the feet of patients with diabetes including assessment of circulation (PVD), neurological status (polyneuropathy) and skin integrity (ulcers, infection) at every ofice visit, but at least bi-annually. PROJECT DEVELOPMENT Assessment Protocol / Structure The goal of this scholarly project was the development of a tool to guide the assessment of feet in patients with diabetes. Since diabetes mellitus is a chronic condition, the assessment of the patients with diabetes should be ongoing. Current research, realistic clinical timeframes, and goals of diabetic management guided the development of this protocol. It is recommended that patients with diabetes should be seen at least bi-annually and should have yearly screenings for complications (ADA, 1995). One of those complications is foot problems and this protocol was designed to aid advanced practice nurses in the assessment of foot status in primary care. The assessment consists of three main parts: history, physical examination, and testing. Decision making is based on the data collected fi'om history, physical examination and testing. The algorithm in figure 3 reflects the overall critical pathway for the assessment of feet of individuals with diabetes in primary care settings. As a patients enters the system as a new patient to the practice or a newly diagnosed diabetic, they are given the initial assessment. If complications are evident upon data collection, then they are treated and / or referred as necessary. Ifthe FOOT ASSESSMENT 18 Patient with Initial Assessment Diabetes Mellitus Identification of needs - enters system Require immediate attention? Yes- Abnormal -Normal findings Nfindings ‘ I Treat or Refer Reassess in 1 - 6 months Routine Assessment any changes? Yes - Abnormal -Normal Findin s NFindings Treat or Refer Reassess in l- 6 months Figure 3. Critical pathway of diabetic foot assessment. FOOT ASSESSMENT 19 patients status is stable, then reassessment in 1 to 6 months is required. At the interval visit, if the patient's foot status is stable, then further bi—annual assessments are needed unless a complication is noted. If complications are noted then treatment and /or referral is necessary. The initial and interval assessments both consist of health history, physical examination and testing. Bedlam The health history in a new diabetic (either a newly diagnosed existing patient or a diabetic patient new to the practice) on the initial visit should be comprehensive and entail all history to present. The subsequent visits should entail follow - up of identified risks and any additions to the existing health history. The original in - depth history should be readily available on the chart so that the primary care provider is able to review the chart quickly and familiarize him / herself with a particular patient's case, allowing for continuity of care. Although the health history for a new patient with diabetes mellitus will be broad based and cover many body systems, it must also cover information specific to feet. Figure 4 depicts that information specific to foot assessment which should be included in the initial health history. In the initial health history, a provider should note the type and duration of diabetes, past medical history including any previous surgeries (especially vascular), previous foot complications (fi'actures, accidents, injuries, infections), any other chronic illnesses including hypertension, anemia, thyroid dysfunction, coronary artery disease, hyperlipidernia (Campbell et al., 1995; Granfone, 1995; ADA 1994). Lifestyle habits should be noted also including tobacco and recreational drug use, alcohol consumption, eating patterns, weight history, working conditions if employed, types of shoes generally worn, and functional status (Campbell, et al., 1995; ADA 1994). Current insulin or oral hypoglycemic dose, other medications, previous glycohemoglobin results and home glucose monitoring results (usual ranges) are important as well (ADA 1994). The initial health history relevant to foot assessment is depicted in figure 3. FOOT ASSESSMENT 20 INITIAL HEALTH HISTORY - DIABETES (FOOT) Components specifis :9 £99; complisstions tp inclpds in thg initial health histpgy: Type and duration of diabetes mellitus Current medications (including insulins, oral hypoglycemics, other prescription meds, OTC and / or vitamins) Past medical history related to foot foot trauma (surgeries, fiactures, accidents, infections, other foot problems) chronic or past illness (HTN, anemia, thyroid dysfirnction, CAD, PVD, neuropathy, hyperlipidemia, DKA, any other illness) Lifestyle ADLs, functional status, abilities (bathing, ambulation, dress self, perform daily foot care, work, cook meals, exercise, drive) Working conditions (sit or stand mostly during work, hours worked q day, days worked q week, regular breaks, type of work done, other Substance Use Tobacco (years smoked, cigarettes, cigars, quantity q day) Alcohol (type, fiequency, quantity consumed q day, duration, patterns - binging) Recreational drugs (type duration, frequency of use, last used) Diet type of ADA, food allergies, compliance, special needs such as low fat, low cholesterol, vegetarian, etc. weight history (recent or large amounts of gains or losses, intentional vs. unintentional weight changes) Diabetes Care Home glucose monitoring (fiequency, results, usual range of BS, type of meter, urine dipsticks) Previous glycohemoglobin results (if available) Footwear types worn, orthotics, wear patterns Sensations in feet pain, aches, bunting, numbness, tingling, etc. Knowledge about foot complications, foot self care Figure 4. Initial health history components. FOOT ASSESSMENT Interval Foot Assessment (Figure 5) Name: Chronic Diseases: DATE DATE DATE DATE History/Risk Factors Changes in : MEDS ADLS Substance Use Foot Care Diet Other Physical Exam Gait Skin Integrity Nails Color Hair Dryness Structure Temperature Pulses Reflexes Testing Temperature Cotton Map A 5 r I 0 l ‘ If Monofrlament w / ’l. Wear Pattern of Insole/Shoe 7. .4) A”) Other Findings , r ' \ Education/Counseling Ii" Treatment/Referrals Signature FOOT ASSESSMENT 22 The interval assessment form (figure 5) is to be used on subsequent visits. The detailed history information (as well as objective data) will have been obtained on the initial visit and can be briefly updated on the subsequent (interval) visits via the interval flow sheet. Any changes or additions can be made directly on the flow sheet. In the health history section of the interval foot assessment, any changes in the previous history or risk factors for foot complications should be identified. Since the flow sheet has several dates listed, it will be easy to compare findings between visits. The interval visit should be brief yet comprehensive. Patient education should be incorporated into the process of diabetic foot assessment as the APN will also have to assess the level of knowledge regarding foot self care. Physig Em’ tion The physical examination should consist mainly of inspection and palpation of the feet. Inspection should include visualization of feet bilaterally with socks ofl‘. This has been noted to be the most worthwhile and important element in the overall assessment of the diabetic foot (ADA, 1995). Physical examination in both the initial and interval foot assessments should specifically assess many areas. Ifthe assessment in a particular category is normal, document within normal limits (WNL). Otherwise, document any abnormalities. The interval assessment flow sheet is a quick and easy way to document and compare findings to previous data. Since the initial assessment is a broad based physical examination covering all body systems, it will be necessary to incorporate the foot assessment into the overall examination. There is no standard document by which to record findings. It is important to include components specific to foot assessment in physical examination of both the initial and interval assessment. These components pertinent to foot examination include skin integrity, color, stnrcture, hair, dryness, temperature, pulses, reflexes and nails. Inspection should consist of looking at the overall foot for skin integrity (document any ulcerations, atrophy, high pressure areas, calluses, rashes, or lesions) , FOOT ASSESSMENT 23 color (pale, rubor, necrotic, cyanotic, erythematous), nails (thick, color, dry, cracked, ingrown, hygiene), hair (growth pattern, absence of hair), dryness (dryness, excessive moisture), structure (asymmetry, toe shape, deformed shape, arches, muscle tone, foot drop, vein patterns), temperature (hot, cool), dorsalis and post tibial bilateral pulses ([-H-] = normal, [+] = diminished, [0] = absent), and bilateral Achilles reflexes (([++] = normal, [+]= diminished, or [0] = absent). In addition, inspection should include observing gait and stance for any abnormalities such as limping, swaying, and abnormal pressure exertion. A brief inspection of the footwear worn to the appointment may reveal pressure patterns of the foot as well. Palpation of the foot is key in assessing the temperature, moisture, texture, edema, hydration, muscle tone, posterior tibial and dorsalis pedis pulses. Temperature is of importance as a red hot foot may indicate infection while a very cool foot may indicate PVD. Rough callused areas suggest high pressure points. Pulses are extremely important as indicators of circulatory status. Orchard and Strandness ( 1992) reported that the ankle-brachial index (AB1) should be performed on all patients who have decreased or absent tibialis posterior pulses (1992). The ankle - brachial index is done by auscultation of the blood pressures in the foot and the brachial plexus. The equipment need for ABI includes a hand held ultrasound Doppler device (for ankle pressures), stethoscope (for brachial pressures) and a standard size blood pressure cuff (for both). To achieve the ABI, the provider takes a series of blood pressures including those of the right and left arms and right and left ankles at the dorsalis pedis and tibialis posterior. The provider then takes the higher of the arm readings and calculates the ABI by dividing that reading by the pressures obtained in the right and left dorsalis pedis and tibialis posterior. Specific protocol guidelines were set up determining when and to whom to refer based on the ABI findings (Orchard & Strandness, 1992). The procedure is time consuming and the results are subjective, making it not practical in primary care as a routine screening test. Ifthe pedal pulses are FOOT ASSESSMENT 24 not palpable, ischerrria is present, hair loss is evident, and / or symptomatology strongly suggests PVD, then a referral to vascular studies is needed. Isms Diabetic foot ulcerations are most often associated with the loss of sensation of neuropathy. Testing for sensation is a essential part of the routine appointment in primary care. There are a variety of sensation testing devices available however, many of these are not practical for primary care (not cost eficient or time eficient). US. Department of Health and Human Resources (1990) listed reduction of amputations by forty percent as one of its goals to achieve by the year 2000. The goal of testing in the primary care ofice is to identify those patients at risk for ulcerations and amputations. Sensation includes light touch, sharp pain, and thermal elements. Light touch is often assessed with the use of a cotton wisp stroked lightly over the skin. Temperature sensation is most easily done by touching the skin with a small containers carrying water of different degrees of hot and cold. A very easy way to assess pain is by the pinprick test. A pin is first tested on the hand to explain to the patient what he or she may expect to feel. The pin is then placed at several spots on the foot without the patient looking and the patient identifies when the pinprick occurs. Although this is a quick and easy way to assess for sharp sensation, it has some drawbacks. The examiner may apply difi‘erent pressures with the pin to the foot and the examiner may accidently puncture the foot, leaving it at risk for infection. A more reliable and safer device that is easy to use, time efiicient, and cost eficient is the monofilament. The monofilarnent is a device that has a long nylon filament attached to a holder. The filament is pressed against difi‘erent spots on the foot much like the pinprick test. However the filament bends at a given pressure so that the examiner is able to tell the exact pressure exerted on the foot. The procedure is simple as there is a one- second touch, one - second hold and one - second lift. Monofilaments come in three different thicknesses including 4.17, 5.07, and 6.10. The 5.07 monofilament, which bends at a stress of 10 grams, is the most commonly used FOOT ASSESSMENT 25 standard for assessing pressure sensation. Protective sensation is thought to be lost if a patient is unable to feel the 5.07 monofilament . Although there are other fomrs of sensory testing available the monofilament, cotton wisp and containers of varying temperature water are adequate for assessment of foot sensation. Sosenko, Kate, Soto & Bild (1990) found that testing for foot sensation with a monofilament was as efi‘ective as testing with a vibrometer and less time consuming. To document testing on the interval assessment form, use the following: [-H-] = normal, [+] = diminished, and [0] = absent. Document each test done (temperature, cotton wisp, monofilament) and for each foot done (left and right). At the bottom of the interval assessment form, there is space reserved for other findings, and for treatrrrent and / or referrals (if needed). Also there is a section for education and counseling. In this section, document any teaching about risk factors, ways to prevent injury and complications, diabetic foot care, diabetes care in general - anything which would pertain to patients at risk for foot complications. At the very bottom is the signature box where the documentation must be signed by the provider of care. In the way the interval assessment is designed, it is easy to compare one visit with previous visits. Process T et The target patient group for this protocol includes all patients with type I or type II diabetes. The initial assessment should be performed on all newly diagnosed patients with diabetes, any established diabetic patients who have not been followed regularly and those diabetic patients who are new to the practice. The interval assessment should be performed on all of the established diabetic patients in the practice at least every six months and usually not more than every month, unless there is a specific foot complication undergoing treatment. FOOT ASSESSMENT 26 This protocol was specifically designed to be performed by the APN managing diabetic patients in primary care. However, this protocol is flexible enough to be used by all primary care providers in its current form (APNs, physicians, physicians assistants, etc.). Non - APN nurses who work in primary care may be trained to use this protocol with additional review in history and physical exam, and further education in the foot testing. Others working in primary care could also be trained to do parts of the assessment to allow for more eflicient time spent. Medical assistants and others may be trained to ask specifically about any physical changes or risk factors specific to feet and also prepare the patients feet by having them remove their shoes and socks prior to the primary care provider's examination. Also, elements of this protocol may be modified to nurses working in acute care settings and extended care facilities. Lupe Time is an essential factor in the assessment considering the average appointment time spent with a new diabetic patient is 20 -30 minutes and with an established patient is 10 -15 minutes. However since half of all amputations in the United States are directly related to diabetic foot complications many which are preventable, it is warranted to allow extra time for diabetic foot assessment. Also it is important to keep in mind that primary care providers must assess other key body systems with diabetics, not only their feet and that extra time is clearly justifiable. By utilizing the medical assistants who place patients in the exam rooms to prepare patients for foot assessment, time will be better used. stt Cost is a major factor in whether a protocol is or is not used. By requiring a more thorough assessment of patients with diabetes, extra time will be needed. Extra time costs extra money as it decreases the number of other patients seen in a given day. However, it is economically unwise and impractical to holistic primary care to refer patients out for foot assessment when it can be (and should be) done within the primary care setting. It is FOOT ASSESSMENT 27 also unwise and risky to not perform foot assessments biannually on diabetic patients as it increases the chance for serious foot complications to occur. The cost of amputation, long term treatment of infections and hospitalizations are exorbitant when compared to the extra few minutes required to complete the foot assessment. A formula depicting the cost of implementing the protocol would be as follows: Cost = (number of diabetes mellitus patients in the practice) x (additional length of time required for foot assessment) x (cost per hour of clinic time) Although the cost for implementing proper foot assessment may seem high, the extra time needed for assessment per visit would be ofl‘set by the reduction in hospitalizations, amputations and treatment of foot complications. In a managed care setting, this assessment could have a tremendous impact in the overall reduction of costs. Overall, the cost of implementing this protocol in primary care would be balanced out by the improved quality of life for the diabetic patients. The quality of life for those with diabetes would increase as self care is stressed. As less people experience ulcers and amputations it would follow that less days off work and less lifestyle interruptions are experienced. Outcomes Diabetic foot problems result in significant morbidity and mortality (ADA, 1995). The modified model based on Starfield provides a basis for evaluation of the diabetic foot assessment protocol. The impact of the foot assessment can be measured by the outcomes including the number of foot problems that diabetics in the practice have, the lengths of hospital stays, work days lost, duration of care, number of recurrences, and patient satisfaction. The structure and process of the assessment protocol set the groundwork for the evaluation. If the practice is accessible to the patient with diabetic foot complications, then patient satisfaction is thought to be high. If the patient with diabetes has received regular foot assessments and instructions regarding foot self care, then it would be FOOT ASSESSMENT 28 surmised that compliance and early detection of complications would be increased. Chart review would be a major factor in evaluating the outcomes of care as well. It could show the progress (or lack) that patients may make in regards to compliance with medications, diet, diabetic care. It could also show the continuity of care and the tracking of any problems identified by the primary caregiver during visits. Implications for Advanced Nursing Practice in Primary Care The diabetic foot assessment protocol would be a positive addition to the APN in primary care in many ways. Efi‘ectiveness of routine visits would increase as the ability for early detection and prevention of complications would be emphasized. Both long and short term goals could be measured as outcomes. The outcomes would provide basis for research in both long and short term. In the long term, an APN could research the number of diabetic patients in the practice, the number who have experienced foot complications, the average visit fi'equency for diabetics, and the average level of functional status. The possibilities for research are nearly endless as there would be plenty of demographic information available on the diabetic patients in the practice gathered in the initial and interval assessments. The feasibility of this protocol could be analyzed by reviewing costs spent on foot assessment compared to the cost of complications experienced by diabetics. In the short term, continuous quality improvement (CQI) may be implemented as quarterly chart reviews could also provide ways to measure outcomes. The numbers would also be available for the inspectors during annual reviews. Patient level of knowledge is also both a long and short term goal. The long term goal of educating patients in foot care and risk factors is that there will be reduction in the morbidity rate for diabetic patients. Short term goals include they may be able to notify the primary care office if they note any changes in foot status during their daily routines. Other short term goals for patients education include ability to verbalize risk factors for complications, redemonstration of foot care basics, and reaching the visit to visit goals set. FOOT ASSESSMENT 29 In developing this assessment protocol, the structure - process - outcome model provided a sound basis for the design and evaluation of the tool. This guideline provides a user - fiiendly and needed protocol which is very practical for use in the assessment of feet in patients with diabetes mellitus in primary care. FOOT ASSESSMENT 30 REFERENCES Alpert, 1.. & Chamey, E. W Publication (HRA) 74- 3113. Rockville, MD.: US. Department of Health, Education and Welfare, Public Health Service, Health Resources Administration, 197 3. American Diabetes Association (1995). Clinical practice recommendations 1995. Diabetes Cm, 18, supplement 1. American Diabetes Association (1994). standards of medical care for patients with diabetes mellitus. WWI—7. 616 - 623. American Diabetes Association (1993). W. Alexandria, Va: American Diabetes Association. American Diabetes Association (1993). Position statement: Implications of the diabetes control and complications trial. Dislggs, 42, 1555-1558. American Diabetes Association.(l99l). Position statement: foot care in patients with diabetes mellitus. Diabetes Cgo, 14, 18-19. Campbell D.R., Freeman D.V., & Kozak G.P., (1995). Guidelines in the examination of the diabetic leg and foot. In Kozak, G.P., Campbell D.R., Frykberg RG., & Habershaw, G.M., (Eds), Management of diabetic foot problems 2nd ed. Philadelphia: W.B. Saunders. Caputo, G.M., Cavanagh, P.R., Ulbrecht, J.S., Gibbons, G.W., & Karchmer, AW. (1994). Assessment and management of foot disease in patients with diabetes. m Now Englgo Journal of Mooioine, 331, 854-860. Centers of Disease Control & Prevention - National Center for Health Statistics (1995, November). Reducing tho burden of diabotos; National diabetes foot shm. The Diabetes Control and Complications Trial research group (1993). The efi‘ect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. New England Journal of Medicine, 3_22, 977-986. FOOT ASSESSMEN'I' 31 Dyck, P.J., Kratz, K.M., Lehman, K.A, Kames, J.L., Melton, L.J., O'Brien, P.C., Litchy, W.J., Windebank, A.J., Smith, B.E., Low, PA, Service, F.J., Rizza, RA, & Zimmerman, BA (1991). The Rochester Diabetic Neuropathy Study: Design criteria for type of neuropathy, selection bias, and reproducibility of neuropathic tests. Noorology, 41, 799 -807. Edmonds, M.E. & Foster, AV.M. (1994). The diabetic foot. In Pickup LC. & Williams G. (Eds), WW. London: Blackwell Scientific Publications. Fain, J.A., & Melkus, GD. (1994). Nurse practitioner practice patterns based on standards of medical care for patients with diabetes. W11, 879 - 881. Ford, LC. (1992) Advanced nursing practice: future of the nurse practitioner. In Aiken, L-H-, & Fagin, C-M- (EdSJ, WM. New York: Lippencott (pp. 287 - 299). Granfone, A. (1995). Hyperlipidemia in the diabetic: Accelerated atherosclerosis. In Kozak, G.P., Campbell D.R., Frykberg R.G., & Habershaw G.M..(Eds.), Moosgemmt of diabetic foot problems 2nd ed. Philadelphia: W.B. Saunders. Gerding, D.N., Piziak, V.K., & Rowbotham, TL. (1991). Saving the diabetic foot. Boom Feb. 28 , 1991 (pp. 84,86—88,90,97,98,104,107,108.&110). Gibbons G., & Eliopoulos G; (1984). Infection of the diabetic. In Kozak G., Hoar, C.J., Rowbotham, 1., Wheelock, F ., Gibbons, G. & Campbell D. (Eds), Manogmon; of digs-sip foot problems. Philadelphia: Saunders. Greene, D.A., & Pfeifer, M.A.(l985). Diabetic neuropathy. In Olefsky, J.M., & Sherwin, R.S., (Eds), Dioogos mellitus: Mooogomgt goo compliootions. New York: Churchill Livingstone. Kahn, R. (1992 August). Proceedings of a consensus development conference on standardized measures in diabetic neuropathy. DiMos Cope, 15, supplement 3, (pp. 1080 - 1107). FOOT ASSESSMENT 32 Kenny, S.J., Smith, P.J., Goldschrnid, M.G., Newman, J.M., & Herman,W.H. (1993). Survey of physician practice behaviors related to diabetes mellitus in the US. Diabetos Cm, 16, 1507 - 1510. Kerr, CR, (1995). Improving outcomes in diabetes: A review of the outpatient care of NIDDM patients. MW 63 - 73. Koch L.W., Pazaki S.H., & Campbell JD. (1992). The first 20 years of nurse practitioner literature: An evolution of joint practice issues. W 62- 71. Kozalg G.P., & Giurini, J.M.(l995). Diabetic neuropathies: Lower extremities. In Kozak, G.P., Campbell, D.R., Frykberg, R.G., & Habershaw, G.M.(Eds.), Mansgomont of diabetic foot problems 2nd ed. Philadelphia: W.B. Saunders. Kozak G.P., Rowbotham, J.L., & Gibbons, G.W. (1995). Diabetic foot disease: A major problem. In Kozak, G.P., Campbell, D.R., Frykberg, R.G., & Habershaw, G.M-(EdSJ, WWWPWflpM WB- Saunders. McCance, K.L., & Huether, SE. (1991). P ho h siol : The iol 'c b i for disease in odults and children. St. Louis : CV Mosby. National Institutes of Health (1995 October). Diabetes Statistics Publication No. 96 - 3926. O'Connor, P.J. Diabetes 1. Monograph, Edition No. 177, Home study self- assessment program. Kansas City, Mo. : American Academy of Family Physicians, February 1994. Orchard T.J. & Strandness D.E. Assessment of peripheral vascualar disease in diabetes. mbetes Com. 16. 1199-1209. Olefsky, J.M., & Sherwin, RS. (1985). Di tes melli mana en and complicotions. New York: Churchill Livingstone. FOOT ASSESSMENT 33 Payne T.H., Gabella, B.A., Michael, S.L., Young, W.F., Pickard J ., Hofeldt, F.D., Fan, F ., Stromberg, J.S., & Hamman, RF. (1989). Preventive care in diabetes mellitus: current practices in an urban health-care system. W 745 - 747. Parker, A (1974). The dimensions of primary care: Blueprints for change. In S. Andreopoulos (Ed), MW New York: John Wiley & Sons Pozza, G., Librenti, M.C., Comi, G., & Canal, N. (1985). Treatment of diabetic somatic neuropathy. In Crepaldi, G., Cunha-Vaz, JG., Fedele, D., Mogensen, CE, & Ward JD(Eds.),Mirv 1 tin r1 ' mli ' fi .NewYork: Springer Verlag. Sosenko, J .M., Kato, M., Soto, R., & Bild DE. (1990). Comparison of quantitative sensory-threshold measures for their association with foot ulceration in diabetic patients. QioootosCaoofi, 1057-61. Starfield, B., (1992). W. New York: Oxford University Press. Stolar, M.W. (1995). Clinical management of the NIDDM Patient - Impact of the American Diabetes Association practice guidelines 1985 - 1993. Disoetes Caro, 18, 701- 707. Thomas, P.K. (1994). Diabetic neuropathy: Epidemiology and pathogenesis. In Pickup JC & Williams G. (Eds), Chronic Complications of Diabotos, Boston : Blackwell Scientific Publications. Thomas, P.K., & Brown, M.J. (1987) Diabetic polyneuropathy. In Dyck, P.J., Thomas, P.K., Asbury, A.K., Winegrad, A.I., & Porte, D. (Eds), Diabotic Neuropothy. Philadelphia: W.B. Saunders. US. Department of Health and Human Services - Public Health Service (1990) Hogthy Peoplo 2000: National health promotion and disease provention objectives. FOOT ASSESSMENT 34 Wylie-Resett, J ., Walker, E.A., Shamoon, H., Engel, S., Basch, C., & Zybert, P. (1995). Assessment of documented feet examinations for patients with diabetes in inner- city primary care clinics. Arohivos of Em'ly Mfliorp' oi, 46-50. Upheld, CR, & Graham, M.V. (1994). Clinical goidelinos u_r' family practico. Gainesville, FL: Barmarrae Books. Appendix American Diabetes Association (1994). Standards of medical care for patients with diabetes mellitus. W 616 - 623. Append l )4 Standards of Medical Care for Patients Willa Diabetes AMERICAN DIABETES ASSOCIATION iabetes is a chronic illness that re- quires continuing medical care and education to prevent acute compli- cations and to reduce the risk of long- renn complications. People with diabetes Should receive their treatment and care from a physician coordinated team. Such teams include. but are not limited to, phy- sicians, nurses, dietitians, and mental health professionals with expertise and a special interesr in diabetes. The following standards define basic medical care for people with diabe- tes. These Standards are net intended to preclude more extensive evaluation and management of the patient by other spe- cialists as needed. These standards of diabetes care will provide: 1) Physicians and ether health-care professionals who treat peo- ple with diabetes with a means to 0 Set treatment goals 0 Assess the quality of diabetes treatment provided 0 Identify areas where more attention or self-management training is needed 0 Define timely and necessary referral patterns to appropriate specialists 2) People with diabetes with a means to 0 Assess the quality of medical care they receive 0 Develop expectations for their role In the medical treatment Originally approved October 1988. Revised March 1994. 0 Compare their treatment outcomes to standard goals For more detailed information, refer to Medical Management of Insulin- Dependcnt (Type 1) Diabetes, Medical Man- agement ofNon-lnsulin-Dependent (Type II) Diabetes, and Therapy for Diabetes Mellitus and Related Disorders. GENERAL PRINCIPLES— Persis- tent hyperglycemia is the hallmark of all forms of diabetes. Treatment aimed at lowering blood glucose levels to or near normal in all patients is mandated by the following proven benefits: 1. The danger of acute decompensa- tion due to diabetic keteacidosis or hyperesmelar hyperglycemic non- ketotic syndrome, with their ac- companying morbidity and mortal- ity, is markedly reduced. 2. The symptoms of polyuria, poly- dipsia, fatigue. weight less with polyphagia, blurred vision, and vaginitis er balanitis are alleviated. 3. The risks of development or pro- gressien of diabetic retinopathy, ne- phropathy, and neuropathy are all greatly decreased. It is possible that these complications may even be prevented by early normalization of metabolic status. 4. Near normalization of blood glu- cose has not yet been demonstrated to reduce the risk for atherosclerotic vascular disease: however, in dia- betic patients with lipoprorein ab- normalities, improved glycemic 55' control is frequently associated mu, a less-atheregenic lipid profile, Achieving near normal or nomu] blood glucose levels in patients ten}, many types of diabetes requires compre. hensive training in self-management and, for most individuals. intensive treatmcm programs. Such programs include the fol. lowing components according to individ. ual patient need: Frequent self monitoring of blood glucose Meticuleus attention to meal planning Regular exercise Physiologically based insulin regimens (i.e., multiple daily injections of short and longer acting insulins er continu- ous subcutaneous insulin infusion) in IDDM and some NIDDM patients Less-complex insulin regimens or oral glucose lowering agents in some NIDDM patients 0 Instrucrien in the prevention and treat- ment of hypoglycemia and other acute and chronic complications Continuing education and reinforcement Periodic assessment of treatment goals To be effective. treatment programs re- quire ongoing suppert from the clinical care team. SPECIFIC GOALS OF TREATMENT IDDM Setting individual patient glycemic tar- gets should take into account the results of prespecrive randomized clinical trials. most netably the Diabetes Control and Complications Trial (DCCT). This trial conclusively demonsrrated that in pa- tients with IDDM the risk of developmenl or progression of retinopathy, nephropa- thy, and neuropathy is reduced 50—75% by intensive treatment regimens when compared with conventional treatment regimens. These benefits were observed with an average hemoglobin A1c of 7.2% in intensively treated groups of patients compared with 9.0% in conventionally Position Statement Tablc l—Glycemic control for people with diabetes r Aetion Biochemical index Nondiabetic Goal suggested .—-—-—— mprandial glucose <115 80-120 <80 >140 Bedtime glucose (mg/d1) < 120 100-140 < 100 >160 Hemoglobin Alc (%) <6 <7 >8 These values are for nonpregnant Indin'duals. “Action suggested“ depends on individual patient circum- stances. Hemoglobin A1: is referenced to a nondiabetic range of 40—60% (mean 5.096, standard deviation 0.5%). treated groups of patients. The reduction in risk of these complications correlated continuously with the reduction in hemo- globin Alc produced by intensive treat- ment. This relationship implies that com- plete normalization of glycemia levels may prevent complications. The nondia- betic reference range for the hemoglobin Alc in the DCCT was 4.0 to 6.0. Because glycohemoglobin values differ in different laboratories, diabetes treatment teams should adju5t their glycohemoglobin val- ues to account for local differences in as- say methodology and nondiabetic refer- ence ranges. Self-monitoring blood glucose targets in the DCCT were 70—120 mydl before meals and at bedtime and <180 mg/dl when measured 1 1/2 to 2 h post- prandially. However, these goals were as- sociated with a threefold increased risk of Severe hypoglycemia. Therefore, it may appropriate to increase these targets (6g, 80-120 mg/dl before meals and 100-140 mg/dl at bedtime) (Table 1). These targets should be further adjusted in patients with a history of recurrent se- "6re or unrecognized hypoglycemia. Individual treatment goals should take into account the patient’s capacity to UHdeIStand and carry out the treatment regimen, the patient’s risk for severe hy- POglycemia, and other patient factors that may increase risk or decrease benefit (38.. very young or old age, end-Stage re- nal disease, advanced cardiovascular or Fer€bral vascular disease, or other coex- Bling diseases that will materially shorten MC expectancy). The desired outcome of glycemic control in IDDM is to lower glycohemo- globin (or any equivalent measure of chronic glycemia) so as to achieve maxi- mum prevention of complications with due regard for patient safety. To achieve these goals with intensive management, the following are necessary: 0 Frequent blood glucose monitoring (at leaSt 3-4 times/day) o Nutritional counseling 0 Training in self-management and prob- lem solving 0 Possible hospitalization for initiation of therapy In Situations where resources are unavail- able or insufficient, referral to a diabetes care team for consultation and/or coman- agement is recommended. NIDDM Thus far. there are no randomized clinical trial results similar to those of the DCCT that prove the benefits of near normaliza- tion of blood glucose in NIDDM. How- ever, in NIDDM considerable evidence exists for a relationship between micro- vascular disease and hyperglycemia simi- lar to that proven for IDDM. Therefore, it is reasonable to employ the same glyco- hemoglobin and blood glucose goals de- tailed above for IDDM, pending the out- comes of clinical trials that are Studying the benefits of achieving such goals in NIDDM. When setting treatment goals for NIDDM, the same individual patient charaCteristics should be considered as for IDDM: the patient’s capacity to under- stand and can-y out the treatment regi- men, the patient‘s risk for severe hypogly- cemia, and other patient factors that may increase risk or decrease benefit (e. g., ad- vanced age, end-Stage renal disease, ad- vanced cardiovascular or cerebrovascular disease, or other coexisting diseases that will materially shorten life expeCtancy). NIDDM treatment methods should emphasize diabetes management through dietary modification and exercise and weight reduction, supplemented when indicated by glucose lowering agents and/or insulin. When insulin treat- ment is needed, large doses may be re- quired to reach these glycemic targets in some patients, especially in obese insulin- resistant patients. There is less certainty that the risk-to-benefit ratio of intensive insulin treatment is as favorable in NIDDM patients as in IDDM patients. INITIAL VISIT Medical history The comprehensive medical hiStory can uncover symptoms that will help estab- lish the diagnosis in the patient with pre- viously unrecognized diabetes. If the di- agnosis of diabetes has already been made, the history should confirm the di- agnosis, review the previous treatment, evaluate the past and present degree of glycemic control, determine the presence or absence of the chronic complications of diabetes, assiSt in formulating a man- agement plan, and provide a basis for continuing care. Elements of the medical history of particular concern in patients with diabetes include: 0 Symptoms, results of laboratory tests, and special examination results related to the diagnosis of diabetes 0 Prior glycohemoglobin records 0 Eating patterns, nutritional status, and weight hiStory; growth and develop- ment in children and adolescents 0 Details of previous treatment pro- grams, including nutrition and diabe« tes self-management training \ . DlAlr'n-r f‘.-- ..... ... -- ‘I" -.-._____ r I ‘AA. — Position Statement 0 Current treatment of diabetes, includ- ing medications, meal plan, and results of glucose monitoring and patients' use of the data 0 Exercise hIStory 0 Frequency, severity, and cause of acute complications such as ketoacidosis and hypoglycemia 0 Prior or current infections, particularly Skin, foot, dental, and genitourinary 0 Symptoms and treatment Of chronic complications associated with diabetes: eye; kidney; nerve; genitourinary (in- cluding sexual), bladder, and gaStroin- testinal function; heart; peripheral vas- cular; fOOt; and cerebrovascular 0 Other medications that may affect blood glucose levels 0 Risk faCtors for atherosclerosis: smok- ing, hypertension, obesity, dyslipi- demia, and family history 0 History and treatment of Other condi- tions including endocrine and eating disorders 0 Family hiStory of diabetes and Other endocrine disorders 0 Gestational history: hyperglycemia, de- livery of an infant weighing >9 lb, tox- emia, Stillbirth, polyhydramnios, or other complications of pregnancy 0 Lifestyle, cultural, psychosocial, educa- tional, and economic faCtors that might influence the management of diabetes Physical examination A physical examination should be per- formed during the initial evaluation. Peo- ple with diabetes have a high risk of de- veloping eye. kidney, fOOt, nerve, cardiac, and vascular complications. Patients with IDDM have an increased frequency of au- toimmune disorders, especially thyroid disease. All individuals with poorly con- trolled diabetes are at increased risk for infections. Children with poorly con- trolled diabetes may have delayed growth and maturation. Therefore, certain as- peCIs of the detailed physical examination require Special attention. These include: 0 Height and weight measurement (and comparison to norms in children and adolescents) 0 Sexual maturation (during peripuber- tal period) 0 Blood pressure determination (with or- thostatic measurements when indicated) and comparison to age-related norms Ophthalmoscopic examination (pref- erably with dilation) 0 Oral examination 0 Thyroid palpation 0 Cardiac examination 0 Abdominal examination (e.g., hepato- megaly) Evaluation of pulses (by palpation and auscultation) O Hand/finger examination Foot examination 0 Skin examination (including insulin- injection sites) Neurological examination The clinician should also be alert for signs of diseases that can cause sec- ondary diabetes, e.g., hemochromatosis, pancreatic disease, and endocrine disor- ders such as acromegaly, pheochromocy- toma, and Cushing's syndrome. Laboratory evaluation Blood glucose teSting and urine ketone teSting should be available in the office for immediate use as needed. In addition, each patient should undergo laboratory teStS that are appropriate to the evaluation of the individual‘s general medical condi- tion. Certain teStS should be obtained to eStablish the diagnosis of diabetes, deter- mine the degree Of glycemic control, and define associated complications and risk factors. These include: o Fasting plasma glucose (a random plasma glucose may be obtained in an undiagnosed symptomatic patient for diagnosuc purposes) 0 Glycohemoglobin o FaSting lipid profile: total choleSterol, high-denSIty lipoprOtein (HDL) choles- terol. triglycerides, and low-density li- poprOteIn (LDL) cholesterol 0 Serum creatinine in adults; in children if proteinuria is present 0 Urinalysis: glucose, ketones, protein, sediment 0 Determination for microalbuminuria (e.g., timed specimen or the albumin/ creatinine ratio) in postpubertal pa- tients who have had diabetes at leaSt 5 years and all patients with NIDDM o Urine culture, if sediment is abnormal or symptoms are present 0 Thyroid funCtion teSt(s) when indicated 0 EleCtrocardiogram (in adults) Management plan A complete, organized medical record system is essential to provide ongoing care of people with diabetes. The records always must be accessible to the diabetes treatment team and organized so that they not only document what has occurred but serve as a reminder of what should be done at appropriate intervals. The management plan should be formulated as an individualized thera- peutic alliance among the patient and family, the physician, and other members of the health-care team skilled in the man- agement of diabetes to achieve the desired level of diabetes control. Patient self- management Should be emphasized. To this end, the management plan Should be formulated in collaboration with the pa- tient, and the plan should emphasize the involvement of the patient in problem solving as much as possible. A variety of strategies and techniques should be em- ployed to provide adequate education and development of problem-solving skills in the various aspects of diabetes management. When formulating this manage- ment plan, consideration should be given to the age, school or work schedules and conditions, physical activity, eating pat- terns, social situation and personality. cultural factors, and presence of compli- cations of diabetes or Other medical con- ditions. Implementation of the manage. ment plan requires that each aspect be understood and agreed upon by the pa- tient and the care providers and that the goals and treatment plan are reasonable. The management plan should include: 0 Statement of short- and long-term g08l5 0 Medications (Insulin, oral glucoSC' lowering agents, glucagon, antihypef' tensive and lipid-lowering agents. other endocrine drugs. and Other medications) g 1 Position Statement o Individualized nutrition recommenda- tions and inStruCtions, preferably by a regISIered dietitian familiar with the components of the dietary manage- ment of diabetes . Recommendations for appropriate life- style changes (e.g., exercise, smoking cessation) 0 Patient and family education for self- management that is consistent with the National Standards for Diabetes Patient Education Programs, preferably pro- vided by a Certified Diabetes Educator 0 Monitoring inStrucnons: self-monitor- ing of blood glucose (SMBG), urine ketones, and use of a record syStem. Frequency of SMBG should be individ- ualized according to clinical circum— Stances, the form of treatment em- ployed, and the response to treatment. Urine glucose may be considered as an alternative only if the patient is unable or unwilling to perform blood glucose teSting or if the only goal is avoidance of symptomatic hyperglycemia 0 Annual comprehenswe dilated eye and visual examinations by an eye donor for all patients age 12 and over who have had diabetes for 5 years, all patients over the age of 30, and any patient with visual symptoms and/or abnormalities 0 Consultation for podiatry services as indicated 0 Consultation for specialized services as indicated 0 Agreement on continuing support and follow-up and return appointments 0 Instructions on when and how to con- tact the physician or Other members of, the health-care team when the patient has not been able to solve problems and for management of acute problems 0 For women of childbearing age, discus- sion of contraception and emphasis on the necessity of optimal blood glucose control before conception and during pregnancy ° Dental hygiene SQNTINUING CARE — Continu- mg care is essential in the management of Wery patient with diabetes. At each visit, the patient‘s progress in achieving treat- ment goals should be evaluated by the health-care team, and problems that have °CCurred should be reviewed. If goals are \g DMRFTCC r anr I ~- - « .r In n-n- ‘ ‘..-._ ‘ 1n 1 not being met, the management plan needs to be revised and/or the goals need to be reassessed. - Visit frequency The frequency of patient visits depends on the type of diabetes, the blood glucose goals and the degree to which they are achieved, changes in the treatment regi- men, and presence of complications of di- abetes or other medical conditions. Patients initiating insulin therapy or having a major change in their insulin program may need to be in contact with their care provider as Often as daily until glucose control is achieved, the risk of by poglycemia is low, and the patient is com- petent and comfortable implementing the treatment plan. Some patients may re- quire hospitalization for initiation or change of therapy. Patients beginning treatment by diet or oral glucose-lowering agents may need to be contaCIed as often as weekly until reasonable glucose control is achieved and the patient is competent to conduct the treatment program. Regular visits should be scheduled for insulin- treated patients at least quarterly and for other patients quarterly or semiannually, depending on achievement of treatment goals. More frequent contact also may be required if the patient is undergoing in- tensive insulin therapy, nOI meeting gly- cemic or blood pressure goals, or has ev- idence of progression in microvascular or macrovascular complications. Patients must be taught to recognize problems with their glucose control as indicated by their records of self-monitoring of blood glucose and to promptly report concerns to the health-care team to clarify and Strengthen their self-management skills. They also should be taught to recognize early signs and symptoms of acute and chronic complications and to report these immediately. Severe hypoglycemic reac- tions requiring the assistance of another person muSt be reported as soon as possible. Medical history An interim hIStory should be obtained at each visit and include: 1) frequency, causes, and severity of hypoglycemia or hyperglycemia; 2) results of self-monitor- ing; 3) adjustments by the patient of the therapeutic regimen; 4) problems with adherence; 5) symptoms suggesting de- velopment of the complications of diabe- tes; 6) other medical illnesses; 7) current medications; 8) psychosocial issues; and 9) lifestyle changes. Physical exam At every regular visit, height (until matu- rity), weight, and blood pressure should be measured. Sexual maturation should be evaluated periodically in peripubertal patients. Portions of the physical exami- nation that were found to be abnormal on previous visits should be repeated. The fundi should be examined at regular visits (preferably with dilation). If retinopathy is detected for the first time or has pro- gressed or if there are visual symptoms, the patient Should be referred to an eye doctor for a prompt, complete dilated eye and visual examination. The feet should be examined at every regular visit for as- sessment of vascular Status, skin condi- tion, and sensation. If there is evidence of significant ischemia, loss of proteCtive sensation. deformity, ulceration, or infec- tion, the patient should be referred to the relevant specialist for appropriate testing, treatment, or intensive education as indi- cated. The physical examination should also be extended to include areas indi- cated by the interim hi5tory. Comprehensive dilated eye and visual examinations Should be performed annually by an eye donor for all patients age 12 and over who have had diabetes for 5 years, all patients over the age of 30, and any patient with visual symptoms and/or abnormalities. Laboratory A glycohemoglobin determination should be performed at least quarterly in all insulin-treated patients and as fre- quently as necessary to assess achieve- ment Of glycemic goals in non-insulin- treated patients. A faSting plasma glucose test may be useful to judge glycemic con- — Position Statement trol in NIDDM patients. The value ob- tained from a plasma glucose test also may be useful for comparison with the value obtained simultaneously by the patient using his/her own monitoring syStems. Adults who have abnormal lipid profiles should be tested annually for total cholesterol, fasting triglycerides, HDL- cholesterol, and LDLccholesterol. If treat- ment is inStituted for dyslipidemia, the appropriate laboratory measurement Should be repeated as needed to monitor therapy. Adults who have normal lipid profiles should have values repeated in 5 years. A lipid profile should be per- formed on children older than 2 years, after diagnosis of diabetes and when glu- cose control has been established. Bor- derline or abnormal values should be re- peated for confirmation. If values fall within accepted risk levels, assessment should be repeated every 5 years. Abnor- mal values requiring inStitution of ther- apy should be repeated following the Na- tional Cholesterol Education Program Adult Treatment Panel 11 (ATPll) Report guidelines. Routine urinalysis should be per- formed yearly in adults. In pOStpubertal patients who have had diabetes for 5 years, a timed urine colleCtion specimen (e.g., 24 h or overnight) should be teSted for the presence of microalbumin or the albumin/creatinine ratio should be mea- sured yearly. lf abnormal albumin or pro- tein excretion is deteCted, serum creati- nine or urea nitrogen concentrations should be measured and glomerular fil- tration assessed. Management plan The management plan should be re- viewed at each regular visit to determine progress in meeting goals and to identify problems. This review should include the control of blood glucose levels, assess- ment of complications. control of blood pressure, control of dyslipidemia, nutri- tion assessment, frequency of hypoglyce- mia, adherence to all aspects of self-care. evaluation of the exercise regimen, fol- low~up of referrals, and psychosocial ad- juStment. In addition, knowledge of dia- betes and self-management skills should be reassessed at least annually. Continu- ing education should be provided or en- couraged. SPECIAL CONSIDERATIONS Children and adolescents Approximately three-quarters of all newly diagnosed cases of IDDM occur in indi- viduals below the age of 18 years. Care of this group requires integration of diabetes management with the complicated phys- ical and emotional growth needs of chil- dren, adolescents, and their families. Di- abetes care for children of this age group should be provided by a team that can deal with these special medical, educa- tional, nutritional and behavioral issues. At the time of initial diagnosis, it is extremely important to establish the goals of care and to begin diabetes self-manage- ment training. A firm educational base Should be provided so that the individual and family can become increasingly inde- pendent in the self-management of diabe- tes. Glycemic goals may need to be mod- ified to take into account the fact that mOSt children under the age of 6 or 7 years have a form of “hypoglycemic un- awareness," in that they lack the cognitive capacity to recognize and respond to hy- poglycemic symptoms. Intercurrent ill- nesses are more frequent in young chil- dren. Sick-day management rules must be eStablished and taught to prevent hos- pitalization. A nutritional assessment should be performed at diagnosis and an— nually by an individual experienced with the nutritional needs of the growing child and the behavioral issues that impact on adolescent diets. Caution must be exer- cised to avoid over-aggressive dietary ma- nipulation In the very young. Assessment of lifeStyle needs should be accompanied by possible modifications of the diabetic regimen. For example. an adolescent who requires more flexibility might be sw1tched to a 3-4 insulin injection pro- gram when needed. A major issue deserving emphasi: in this age group is that of “compliance‘ No matter how sound the medical regi. men, it can only be as good as the abllll) of the family and/or individual to imple. ment it. Health-care providers who care for children and adolescents muSI there- fore be capable of evaluating the behav. ioral, em0tional, and psychosocial factors that interfere with implementation and then work with the individual and family to resolve problems that occur and/or to modify goals as appropriate. Referral for diabetes management For a variety of reasons, it may not be possible to provide care that meets these standards or achieves the desired goals of treatment. In such inSIances, the patient should be referred to a diabetologist/endoc- rinologist-led diabetes treatment team for consultation and/or comanagement. Intercurrent illness The stress of illness frequently aggravates glycemic control and necessitates more frequent monitoring of blood glucose and urine ketones. Marked hyperglycemia re- quires temporary adjustment of the treat- ment program, and, if accompanied by ketosis. frequent interaction with the dia- betes care team. The patient treated with oral hypoglycemic agents or diet alone may temporarily require insulin. Ade- quate fluid and caloric intake mu5t be as- sured. InfeCtion or dehydration is more likely to necessitate hospitalization of the person with diabetes than the person without diabetes. The hospitalized paliem should be treated by a physician with ex- pertise in the management of diabetes. Diabetic ketoacidosis and hyperosmolar hyperglycemic nonketotic syndrome These conditions represent decompcnsa' tion in diabetic control and require im- mediate treatment. Careful evaluation 0 the patient for associated or precipttaunf events muSt be undertaken (e.g.. mlec- tion, medications, vascular events). an associated problems must be treated 3? Position Statement propriately. Depending on the severity of the illness and available resources, treat- ment can be initiated in the physician‘s office, but is best carried out in the emer- gency room, hospital room, or intensive- care unit. Because of the potential morbidity and mortality of diabetic keto- acidosis and the hyperosmolar hyper- glycemic nonketotic syndrome, prompt consultation with a diabetologist/endo- crinologist is recommended when the ini- tial clinical and/or biochemical state is markedly abnormal, when the initial re- sponse to Standard therapy is unsatisfac- tory, or when metabolic complications or cerebral edema occur. Recurrence of dia- betic ketoacidosis demands a detailed psychosocial and educational evaluation by a diabetes specialiSt. Severe or frequent hypoglycemia The occurrence of severe, frequent, or un- explained episodes of hypoglycemia may be due to a number of factors such as de- fective counterregulation, hypoglycemia unawareness, insulin dose errors, and ex- cess alcohol intake. This may also be a consequence of the therapeutic regimen and always requires evaluation of both the management plan and its execution by the patient. Family members and close assoc1ates of patients using insulin Should be taught to use glucagon. The successful accomplishment Of these goals requires more frequent pa- tient contacts during readjustment of the treatment program and patient/family rev education. PREGNANCY — To reduce the risk 0f fetal malformations and maternal and fetal complications, pregnant women and Women planning pregnancy require excel- lent blood glucose control. These women “96d to be seen by a physician frequently, "“15! be trained in self-monitoring of blood Ucose, and may require specialized labo- “100' and diagnOStic tests. Consultation ““h an Obstetrician, ophthalmologist, and mitd'ical specialist in diabetes is indicated lore and during pregnancy. Because of the need for prepreg- nancy planning and excellent glucose \ \ ¥ HICKE) (I‘D: unlltlll: ‘7 x-Inanrn ‘ I....- 1nna control, every pregnancy in a woman with diabetes should be planned in advance. Therefore any diabetic woman who is not currently attempting to conceive Should be informed of and Offered acceptable and effective methods of contraception. RETINOPATI'IY— EStablished dia- betic retinopathy and its complications and other eye diseases, such as cataracts and glaucoma, that may be associated with dia- betes require care by an ophthalmologist experienced in the management of people with diabetes. (see “Screening for Diabetic Retinopathy" position Statement.) NYPERTENSION— Hypertension contributes to the development and pro— gression of chronic complications of dia- betes. In patients with IDDM, perSIStent hypertension is often a manifeStation of diabetic nephropathy, as indicated by concomitant elevated levels Of urinary al- bumin and, in later Stages. by a decrease in the glomerular filtration rate. In pa- tients with NIDDM, hypertension often is part of a syndrome that also includes glu- cose intolerance, insulin resistance, obe- stty, dyslipidemia, and coronary artery disease. Isolated systolic hypertension may occur with long duration of either type of diabetes and is, in part, due to inelaSticity of atherosclerOtic large ves- sels. Control of hypertension has been demonstrated to reduce the rate of pro- gression of diabetic nephropathy and re- duce the complications of hypertensive nephropathy, cerebrovascular disease, and cardiovascular disease. General principles Lifestyle modifications should initially be employed to reduce blood pressure un- less hypertension is at an urgent level. Such methods include weight loss, exer- CIse, reducuon of dietary sodium. and limiting consumption of alcohol. If life- style modifications do nOt achieve Speci- fied goals, medications should be added in a Stepwise fashion until blood pressure goals are reached. Several medications in patients with albuminuria (e.g., angiotensin con- verting enzyme [ACE] inhibitors) appear to have selective benefit in patients with diabetes. Other cardiovascular risk faCtors, such as smoking. inactivity, and elevated LDL cholesterol levels, should also be treated concomitantly. Specific goals of treatment Hypertension traditionally has been de- fined as a syStolic blood pressure 2140 mmI-Ig and/or a diastolic blood pressure of 290 mmI-lg. Most epidemiological Studies have suggeSIed that risk due to elevated blood pressure is a continuous funCtion, so these cumff levels are arbi- trary. In the general population, the risks for end-organ damage are lowest when the syStolic blood pressure is <120 mmI-Ig and the diastolic is <80 mmI-Ig. The primary goal of therapy for adults should be to decrease blood pres- sure to <130/85 mmI-lg. In children, blood pressure should be decreased to the corresponding 90th percentile values. For patients with an isolated sys- tolic hypertension of 2180 mmI-lg. the goal is a blood pressure < 160 mmHg. For those with syStolic blood pressure of 160-179, the goal is a reduction of 20 mml-lg. If these goals are achieved and well-tolerated, further lowering to 140 mml-Ig may be appropriate. NEPI'IROPATI‘IY— The patient with abnormal renal funCtion is at in- creased risk for end Stage renal disease and cardiovascular disease and requires heightened attention and control of other risk factors (e. g., hypertension, smoking). General principles PerSIStent albuminuria in the 30-300 mg/24 h range, known as microalbumin- uria, has been shown to be the earliest stage of diabetic nephropathy. Patients with microalbuminuria will likely progress to clinical albuminuria (2300 mg/24 h) and decreasing glomerular fil- tration rate (GFR) over a period of years. Once clinical albuminuria occurs, the risk for end Stage renal disease (ESRD) is high in IDDM and significant in NIDDM. Hy- — Position Statement pertension usually develops during the Stages of micro— or clinical albuminuria and, if untreated, can hasten the progression of renal disease. Over the pan several years, a number of interventions have been demon- strated to retard the initial development or rate of progression of renal disease. Specific goals of treatment Intensive diabetes management with the goal of achieving near norrnoglycemia has been proven to delay the onset of micro- albuminuria and delay the progression of microalbuminuria to clinical albuminuria in patients with IDDM. Excellent meta- bolic control has been shown to reduce the development of microalbuminuria by 35% and of clinical albuminuria by 60%. (See SPECIFIC GOALS or TREATMENT: IDDM.) Lowering blood pressure in by- pertensive individuals to <130/85, by any effeCtive means, should be the goal in hypertensive individuals. A reduction in blood pressure will also decrease the rate of progression of diabetic nephropathy. Urinary albumin excretion should be lowered as much as possible in normo- tensive individuals with elevated excre- tion rates. The decline in GFR and rise in serum creatinine in individuals who have developed overt nephropathy Should be slowed or halted if possible. Treatment of hypertensive IDDM patients who have microalbuminuria or Clinical albuminuria with ACE inhibitors has been shown in clinical trials to delay progression from microalbuminuria to clinical albuminuria and to Slow the de- cline in GFR in patients with Clinical al- buminuria. Current data suggeSt that nor- motensive patients with albuminuria may also benefit from ACE inhibitors. Measurement of urine albumin should be done on a 24-h or Other timed urine collection. Altematively, the ratio of albumin to creatinine concentration can be measured in a random urine specimen. Elevation of urinary albumin excretion should be confirmed at leaSt once before initiating specific interventions. Assessment of the creatinine clearance Should be performed using the serum creatinine and formulas that take into account the patient's age, gender, and body size or by measuring creatinine in serum and in a timed urine specimen. The creatinine clearance overestimates GFR so that such methods do not detect an early decline in kidney function. Clear- ances of radionuclide-labeled filtration markers more accurately eStimate GFR but can usually be obtained only in spe- cialized laboratories. Repeat timed or overnight urine collections to document treatment effect on albumin excretion and to detect the rare case of a deleterious effect of drug therapy should be obtained periodically. If ACE inhibitors are used, serum potas- sium levels should also be monitored for the development of hyperkalemia, with an increased frequency of monitoring when there is a progressive decrease in GFR or in patients with hyporeninemic hypoaldosteronism. PTOIein restriction to 0.8 g - kg body at” - clay"l (~10% of daily calories), the current adult recommended daily allow- ance for protein, should be instituted with the onset of nephropathy. Pretein-restricted meal plans should be designed by a regis- tered dietitian familiar with all components of the dietary management of diabetes. Referral to a physician experienced in the care of diabetic renal disease should be considered when the GFR has fallen to either <70 ml ° min.l - 1.73 In"2 or when serum creatinine has increased above 2.0 mg/dl or when difficulties occur in manage-‘ ment of hypertenSIon or hyperkalemia. The rate of progression of renal disease is highly variable among individ- uals. The various factors outlined above have been documented primarily in pa- tients with IDDM and may not be equally applicable in NIDDM patients. CARDIOVASCULAR DISEASE — Evidence of cardiovascu- lar disease such as angina, Claudication, decreased pulses, carOtId bruits, and elec- trocardiogram abnormalities requires ef- forts aimed at correction of contributing risk factors (e.g., Obesity, smoking, hy- pertension, sedentary lifeSIyle, ClySllpi- demia, poorly regulated diabetes) in ad- dition to specific treatment of the cardiovascular problem. Daily intake of aspirin has been shown to reduce cardio- vascular events in patients with diabetes. OYSLIPIOEMIA General principles Diabetes increases the risk for atheroscle- rotic vascular disease. This risk is greateSI in persons who have Other known risk factors (such as dyslipidemia, hyperten- sion, smoking, and obesity). Further- more, in NIDDM there is an additional increased risk for obesity and lipid abnor— malities independent of the level of glyce- mic control. A common abnormal lipid pattern in such patients is an elevation of very-low-density lipoprotein (VLDL), a reduction in HDL, and an LDL fraction that contains a greater proportion of small, dense atherogenic LDL particles. Data about treatment of dyslipi- demia in people with diabetes, especially in children, are limited. However. cun'ent recommendations from the National Cholesterol Education Program ATPII re- port on the general management of ele- vated choleSterOl and triglycerides have set increasingly Stringent treatment tar- gets based on the number of cardiovascu- lar risk factors and the presence of coro- nary heart disease (CHD). These risk factors include premature menopause- without estrogen replacement therapy. diabetes mellitus, hypertension, HDI. CholeSterol <35 mg/dl, smoking, and a family history of premature CHD. BC' cause diabetes appears to eliminate the protective died of female gender agt‘lin-it CI-lD, all adults with diabetes are candl- dates for progressively aggressive therapy- The following recommendations are designed to achieve two major goals 15 a result of treatment of dyslipidemia: l) reducing the risk for developmem - CHD in people without documenlc .1 CH0 and 2) reducing the risk for Pf?! gression of CHD or to cause regress“)n mt people with known CI-lD. Oh... hm Position Statement A meal plan designed both to lower glucose levels and to alter lipid pat- terns and regular physical activity are the cornerstones in the management of lipid disorders. The goal of nutrition therapy should focus on three major Strategies: weight loss if indicated, increased physi- cal activity, and meal plan recommenda- tions individualized for the patient. Weight loss is achieved by reduc- ing tOtal caloric and fat intake and by in- creasing physical aCtiiity. Recommenda- tions for increased physical activity, however, need to be made in the context of the patient‘s hIStory and medical Status. The recommendations should detail a fre- quency. duration, and intensity of exer- cise. If there is an inadequate response to atrial of diet, exercise. and improved glu- cose control, lipid-lowering pharmaco- logical agents are indicated. See the American Diabetes Association consensus statement “DeteCtion and Management of Lipid Disorders in Diabetes" for a complete discussion of the treatment of lipid disorders. The primary emphasis in Children and adolescents with serum lipid abnor- malities should be on glucose control, diet, and exercise. Because there are im- ponant considerations regarding the effi- cacy and safety of drug therapy for dys- lipidemia in children and adolescents, dmg therapy in these individuals Should only be undertaken in consultation with a Physician experienced in the area of lipid dBorders in Children. sl’cdfic goals of treatment The primary goal of therapy for diabetic Patients is to lower LDL choleSterol to $130 mg/dl. The primary goal of therapy "l P€0ple with known CHD is to lower _ LDL cholesterol to $100 mg/dl and Inglycerides to $200 mg/dl. . People with diabetes who have tllgll'ceride levels 21,000 mg/dl are at I,“ 0f pancreatitis and Other manifeSta- “:5 0f the hyperchylomicronemic syn- . The. These individuals need special, bcédiate attention to lower triglyceride to <400 mg/dl. Further reduction ATP goals of < 200 may be beneficial. A secondary goal of therapy is to raise HDL cholesterol to >35 mg/dl in men and >45 mg/dl in women. The primary goalof therapy for children with risk factors in addition to diabetes is to lower LDL cholesterol to < 160 mg/dl. NEUROPATHY— Peripheral dia- betic neuropathy may result in pain, loss of sensation, and muscle weakness. Auto- nomic involvement can affect gastrointes- tinal, cardiovascular, and genitourinary function. Each condition may require special diagnostic teSting and consulta- tion with an appropriate medical special- iSt. Improvement in neuropathy should be sought by increased attention to blood glucose control. Relief can be provided by various medications. alterations in meal plans or dietary intake, or specialized procedures. FOOT CARE— Problems involving the feet may require care by a podiatrist, orthopedic surgeon, vascular surgeon, or rehabilitation SpeciaIiSt experienced in the management of people with diabetes. All patients, especially those with evi- dence of sensory neuropathy and/or pe- ripheral vascular disease. must be edu- cated about the risk and prevention of foot problems, and this education must be regularly reinforced. Patients with a history of previous fOOt lesions, especially those with prior amputations, require preventive fOOt care and lifelong surveillance preferably by a fOOt-care specialist. (See "Foot Care in Pa- tients With Diabetes Mellitus" position Statement.) Bibliography 1. The Diabetes Control and Complications Trial Research Group: The effect of inten- sive treatment of diabetes on the develop- ment and progression of long-term com- plications in insulin-dependent diabetes mellitus. N Engl} Med 329:977—986, 1993 2 Cryer PE. Fisher jN. Shamoon H: Hypo- glycemia (Technical review). Diabetes Care. In press 10. 11. 12. 13. 14. . American Diabetes Association: Nutrition recommendations and principles for peo- ple with diabetes mellitus (Position state- ment). 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Diabetes Care 16 (Suppl. 2):l9-20, 1993 FOOT ASSESSMENT 21 Interval Foot Assessment (Figure 5) Name: Chronic Diseases: DATE DATE DATE DATE History/Risk Factors Changes in : MEDS ADLS Substance Use Foot Care Diet Other Physical Exam Gait Skin Integrity Nails Color Hair Dryness Structure Temperature Pulses Reflexes Testing Temperature Cotton Wisp Monofilament Wear Pattern of Insole/Shoe Other Findings Education/Counseling Treatment/Referrals Signature Interval Foot Assessment Instructions for Documentation . History/Risk Factors - Document any changes in medications, ADLS, substance abuse, foot care and/or diet which have occurred between visits. . Physical Exam - Document any changes and/or abnormal findings - Document normal findings as within normal limits (WNL) for categories of gait, skin integrity, nails, color, hair, dryness, structure and temperature. - Document pulses and reflexes as: [++] = normal, [+] = diminished, [O] = absent . Testing - Document monofilament size used if other than the stande 5.07. - Document tests of temperature, cotton wisp and monofilament for each foot as: [++] = normal, [+] = diminished, [O] = absent . Wear Pattern of Insole/ Shoe - Document WNL if normal. Otherwise, document location of excessive or abnormal wear. . Other Findings - Document any other abnormal pertinent findings. . Education/Counseling - Document any teaching done during visit. . Treatment/Referrals - Document any new treatment or referrals. . Signature - Write date at top of form and signature at bottom of form in spaces provided. .-~d~'-‘-7 l llllilll ill/Ill Hill’llllllll' llllllll’ll'l'll ll 93 02374 9926