1 Impact of Speech Amplification Devices on Quality of Life in Persons Living with Parkinson’s Disease and Hypophonia: A Quality Improvement Project Monica Buhr, AGPCNP, Doctor of Nursing Practice (DNP) Student Cailin McDaniel, AGPCNP, Doctor of Nursing Practice (DNP) Student Michigan State University, College of Nursing April 2024 Abstract 2 Parkinson’s disease (PD) is a progressive, neurodegenerative disorder caused by reduced dopaminergic neurons of the brain that frequently cause speech and voice disturbances (Mohseni et al., 2023). Of the motor and nonmotor symptoms that develop in PD, tremor, speech difficulties, and muscle rigidity are the most common (World Health Organization, 2023). The pathophysiology of PD is not well understood and there is no cure. However, quality of life is immensely impacted. Collectively, the speech disorder of PD is known as hypokinetic dysarthria, occurring in various stages in up to 90% of Persons Living with Parkinson’s Disease (PLwPD) (Mohseni et al., 2023). Hypophonia, or reduced speech intensity, is the most prevalent symptom of hypokinetic dysarthria that develops in about 70% of individuals with PD (Adams, 2020). Symptom management by implementing use of a speech amplification device with behavior management and referral to speech pathology, is key in reducing the impact that hypophonia has on individuals with PD and their carers. The goal of the quality improvement project was to use the available literature and personal interviews to determine whether speech amplification devices could be implemented, effectively utilized, and improve quality of life among this population and those of the population who may face social and economic challenges. Keywords: ‘Parkinson’s,’ ‘Hypophonia.’ ‘Social determinants’ or ‘health disparities.’ ‘Voice amplifier,’ ‘speech therapy.’ Table of Contents 3 I. Introduction………………………………………………………………………………..6 II. Literature Review………………………………………………………………………….7 A. Background……..…………………………………………………………………..……..7 B. Pathophysiology……………………………………………………………………...……8 C. Risk Factors……………………………………………………………………………….9 D. Symptoms…………………………………………………………………………………9 1. Table 1: Symptoms of PD: Motor and Nonmotor…………………..……………10 E. Assessment………………………………………………………………….……………11 F. Stages………………………………………………………………………...……..……12 1. Table 2: Stages of PD……………………………………………………………12 G. Hypophonia…………………………………………………………………………...….12 H. Management……………………………………………………………………….……..13 1. Behavior Therapy…………………………………………………………….…..13 2. Speech Amplification Devices…………………………………………….……..15 III. Quality Care………………………………………………………………………………….17 A. Quality of Life from the Person Perspective……………………………………………..17 B. Quality of Care in Primary Care…………………………………………………………17 C. Social Determinants of Health…………..………………………………………….……18 IV. Framework……………………………………………………………………………….…..19 A. Lewin’s Change Theory………………………………………………….....……………20 B. Plan, Do, Study, Act……………………………………………………….…………….21 1. Table 3: PDSA (Plan)...........................................................................................21 C. Storytelling………………………………………………………………………………23 V. Specific Aims…………………………………………………………………………..……..24 A. Practice Problem……………………………………………………………………...….24 VI. Methods……………………………………………………………………………...………25 4 A. Overview…………………………………………………………………..………….…25 B. Inclusion Criteria…………………………………………………………….……….….25 C. Exclusion Criteria…………………………………………………………….………….26 D. Screening……………………………………………………………………..………….26 E. Demographic Questions……………………………………………………..…………..27 F. Interview Script………………………………………………………………………….27 G. Interview of SLP…………………………………………………………………………27 VII. Ethical Considerations………………………………………………….……….…..………27 VIII. Results……………………………………………………………….….……….…………28 A. Table 4: Recruitment Results………………………………………….………….……….28 IX. Discussion……………………………………………………………………..….…………29 A. Summary…………………………………………………………………………………29 B. Limitations…………………………………………………………….………..………..30 C. Implications for Practice………………………………………………………...……….33 Reference List……………………………………………………………………………...…….35 Appendices……………………………………………………………………………………….41 A. Recruitment Letter……………………………………………………..………...………..41 B. Recruitment Flyer…………………………………………………….……………………42 C. Individual Characteristics: Demographics Questionnaire …………………….…………..43 D. Speech Amplification Device Use in PD & Impact on QoL Interview Questions………..46 E. MSU IRB Approval Document…………………………………………………..…….…..50 F. Community Liaison Support Letter…………………………………………………..….…52 G. SLP Questionnaire…………………………………………………………………………53 5 Parkinson’s disease (PD) is a chronic and progressive neurodegenerative disease in which 6 brain matter changes, causing dopamine loss leading to motor and nonmotor symptoms (Parkinson’s Foundation [PF], 2023). Parkinsonism is a generalized umbrella term that encompasses neurologic disorders that cause the same changes as PD but may include more than the three cardinal symptoms of bradykinesia, rigidity, and a tremor (PF, 2023). In PD, a resting tremor is often the first symptom, followed by muscle rigidity or stiffness, and slowness of movement, also known as bradykinesia (World Health Organization [WHO], 2023). Bradykinesia can cause impairments in ambulation, dressing, writing, and speaking, also known as hypophonia or dysarthria. PD is progressive and other symptoms are likely to develop over time. These early or suspected motor signs of PD need to be differentiated from pyramidal slowing which mimics bradykinesia, or depression that mimics hypokinesia (Bloem et al., 2021). These symptoms, especially those relating to speech and communication, are known to have an impact on quality of life (QoL). Collectively, the speech disorder of PD is known as hypokinetic dysarthria, with a variety of speech related symptoms and occurring in various stages in up to 90% of persons living with Parkinson's disease (PLwPD) (Mohseni et al., 2023). As part of the progressive nature of PD, it is the laryngeal dysfunction that contributes to hypophonia, or reduced speech intensity (Adams, 2020). Therefore, hypophonia is the most prevalent speech-related symptom of hypokinetic dysarthria that develops in about 70% of individuals with PD (Adams, 2020). Although there is no cure for PD, medication management of symptoms and targeted therapies like deep brain stimulation or devices may help to optimize health throughout the progression of the disease (Mohseni et al., 2023). Management of speech disturbances can consist of behavioral or speech therapy but can also be the use of assistive devices like speech amplifiers. For this project, interviews were going to be conducted with PLwPD and hypophonia to evaluate the use of speech amplification devices and the impact these 7 devices had on QoL. Literature Review The literature review was based on the proposed quality improvement (QI) question: How do speech amplification devices impact QoL in people living with PD or parkinsonism and hypophonia? The literature review was conducted using the Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, and EBSCO host databases. Boolean phrases and search terms used included “Parkinsonism” or ‘Parkinson’s,’ and “Hypophonia.” Additional terms used were “social determinants” or “health disparities.” Other included terms were “voice amplifier,” “speech therapy,” and “PD”. The time frame selected was 2018-2024. There were some articles included that are considered scholarly classics on the topics of interest. There is limited research on PD with hypophonia. When adding in demographics, there was even less information available regarding the impact that social and economic challenges have on the plan of care for PLwPD and hypophonia. Background Occurrence of PD is more common in males and most often occurs in adults over the age of 60 (Johns Hopkins University, 2023). In 2019, there were approximately eight and one half million individuals worldwide with a diagnosis of PD; that number is predicted to grow to 12 million by 2050 (Soilemezi et al., 2022; WHO, 2023). In 2022, approximately ninety thousand people were diagnosed with PD in the United States (US), with a previous incidence of forty to sixty thousand annually (Destro, 2022). Though research in PD continues to grow, the information on differences in race and ethnicity are still broad. One challenge lies in the different genetic disposition of races and ethnic groups. Disparities among vulnerable racial and ethnic groups impact PD diagnosis, 8 management, and outcomes. According to Thaler and Alcalay (2022), PD studies have primarily been conducted on individuals of European descent, thus limiting available data regarding minority populations. More recently, a variant linked to the gene B-glucocerebrosidase (GBA1), also correlated with likelihood of PD occurrence (Thomas, 2023). Individuals carrying one copy of the GBA1 gene are one- and one-half times more likely to have PD than individuals without any gene presentation, and three- and one-half times more likely with two copies of the gene. GBA1 is rarely found in those with European or Asian descent but has been found in a majority of individuals of African descent (Thomas, 2023). A lower risk of PD is associated with Asian descent, potentially related to neurological resilience due to lifestyle or diet, or decreased presence of associated genetic risk or mutations (Willis et al., 2022). Research among diverse populations is still needed to continue exploring genetic contributions to developing PD. Pathophysiology The cause and origin of PD has not been specified, leading most PD diagnoses to be labeled as idiopathic, or having an unknown cause (Johns Hopkins University, 2023). Simon et al. described the pathophysiology of PD in detail, but in a way that a lay-person could understand (2020). PD is essentially a loss of brain matter or atrophy that decreases dopamine levels. Dopamine is a neurotransmitter, or responsible for sending messages between nerve cells. Deterioration occurs at the basal ganglia, altering the chemistry of the brain with a decreased level of dopamine neurotransmitters. This decrease in dopamine neurotransmitters then prevents the brain neurons from communicating. The brain sends activation signals to the muscles and dopamine receptors fine tune the movement. Because of this mechanism, a decrease in dopamine is reflected in the slowed movements and tremor symptoms presented in PD. Deterioration continues and symptoms worsen as the disease progresses (Simon et al., 2020). 9 Risk Factors Advancing age is the greatest risk factor for developing PD, with an increased incidence after the age of 70 (Willis et al., 2022). Genetic mutations account for approximately 10% of PD cases, which means either one or both parents were carriers (Cleveland Clinic, 2022); this leaves the remaining 90% of cases idiopathic. Other risks include environmental factors such as pesticides or herbicides, Agent Orange exposure, or occupational exposure to heavy metals and solvents (Johns Hopkins University, 2023). The ‘Rust Belt’, historically consisting of heavy industrial manufacturing, is potentially associated with groupings of higher PD incidence among the midwestern and southern US as well as southern California, Texas, Pennsylvania and Florida (Destro, 2022; Willis et al., 2022). Head trauma is likely to increase the risk of PD but to date, no definitive correlation has been found. It is also likely that PD could be a combination of genetics and environmental exposures (Bloem et al., 2021). This information varies since some genes are more prevalent in certain ethnicities than others (Ben-Joseph et al., 2020). Symptoms PD symptoms can have motor or nonmotor presentations. Symptoms can also be displayed at different times of the day, with varying severity due to the differing presentations of disease progression. Common nonmotor prodromal symptoms, or signs before formal diagnosis, are depression, orthostatic hypotension, or constipation. Motor symptoms tend to be present in all stages and are most pronounced (Thaler & Alcalay, 2022). The cardinal symptoms of PD are remembered as TRAP; tremor, rigidity, akinesia, and posture (Parkinson’s Nebraska, 2016). These symptoms have both motor and nonmotor presentations exhibited through physical movement, speech, and cognitive impairments. Bradykinesia, tremor, and rigidity are the most common symptoms. A list of symptoms can be found in Table 1. Table 1 Symptoms of PD: Motor and Nonmotor PD Symptoms Motor Nonmotor 10 · Back rigidity · Bradykinesia (slowed movements) · Decreased arm swing · Decreased blinking cycles · Difficulty rising from chair · Difficulty turning in bed · Dysphagia (difficulty swallowing) · Flexed elbows, wrists, hips, knees · Forward tilt of body trunk · Freezing in place · Hypophonia (unusually soft & low speaking voice & volume) · Hypomimia (mask-like facial expression) · Micrographia (cramped or small, uphill handwriting) · Short-stepped gait · Shuffling gait · Stiffness (cog-wheel) · Stooped posture · Tremors (rhythmic shaking of muscles) · Anosmia (diminished/lost sense of smell) · Constipation · Depression · Dizziness · Drooling · Hallucinations · Hyperhidrosis (excessive or increased sweating not related to heat or exercise) · Orthostatic hypotension · Parkinson’s-related dementia (difficulty with decision-making, focusing, thinking) · Painful foot cramps · Periodic limb movement disorder (PLMD) · Rapid eye movement (REM) behavior disorder · Restless legs syndrome (RLS) · Sexual dysfunction · Sleep disturbance · Urinary frequency, urgency o Incontinence (UI) o Hands, even at rest o Persistent · Unstable balance/posture Hypophonia, or reduced speech intensity, is the most prevalent speech symptom and can be more severe in atypical Parkinson’s (Wang, 2010). Hypophonia often leads to significant difficulty communicating, especially in social situations (Yuan et al., 2020). Other common speech disturbances associated with PD include imprecise articulation, monoloud speech, a breathy-hoarse voice, variability in rate, or containing intermittent pauses (Mohseni et al., 2023). Collectively, the speech disorder of PD is known as hypokinetic dysarthria, occurring in various stages in up to 90% of PLwPD (Mohseni et al., 2023). 11 The initial presentation of PD may evolve into an atypical diagnosis as the disease progresses. Atypical PD causes PD-like symptoms that have little response, or complete lack of response, to PD medication, causing confusion in making a distinct diagnosis (American Parkinson Disease Association [APDA], 2018). Medication-induced parkinsonism is classified as a type of atypical PD. Medications commonly associated with management of psychological disorders, or nausea that block dopamine receptors in the brain, mimic the process of PD (APDA, 2018). Dementia with Lewy bodies, progressive supranuclear palsy, multiple system atrophy, and vascular parkinsonism are other diseases defined as atypical PD, as similar symptoms of gait abnormality and speech or motor impairments are present (APDA, 2018). Assessment The gold standard in diagnosing PD is pathology, which occurs postmortem (Thaler & Alcalay, 2022). Clinical diagnosis is based on symptom presentation using screening scales such as the Movement Disorder Society-Parkinson’s Disease (MDS-PD) or Unified Parkinson’s Disease Rating Scale (UPDRS) which measure severity and progression of PD (American Physical Therapy Association [APTA], n.d.). The UPDRS focuses on motor and nonmotor aspects of daily life such as sleep, tremor, bowel and bladder elimination, speech and swallowing, writing, and dressing. This scale also includes an assessment of motor function, whether or not pharmacological symptom management is included in the plan of care, and an evaluation of any functional impact of motor complications such as dystonia. The UPDRS is scored upon completion with a higher score correlating with increased severity of symptoms and anticipated disability (APTA, n.d.). Ultimately, a clinical response to pharmacological dopamine replacement confirms suspicion of a PD diagnosis (Thaler & Alcalay, 2022). Stages PD is defined in five stages and is a neurological, progressive, chronic disease that impacts movement, communication, activities of daily living (ADLs), and overall independence (Parkinson’s Nebraska, 2016). 12 Table 2 Stages of PD Stage One Mild symptoms that may be unnoticed and are often accompanied by slight tremors that are unilateral Stage Two Symptoms that affect both sides of the body worsen and cause difficulties in ambulation Stage Three A loss of balance and increase in akinesia, or impairment of voluntary limb movements, causes significant impairment in ADLs, independence, and an increasing number of falls Stage Four A transitional period in which living independently is no longer manageable; symptoms increase in severity leading to limited mobility which increases risk for injury; safety is a major concern Stage Five Complete immobility requiring the person to be wheelchair or bed bound with caregiving needed around the clock; nonmotor symptoms are common, especially hallucinations Hypophonia Hypophonia, or reduced speech intensity, is the most prevalent symptom of hypokinetic dysarthria. Hypophonia can lead to difficulties in communication and social interaction (Adams, 2020). Communication impairments related to alterations in motor speech control and cognitive dysfunction have physiological implications, both perceptually and acoustically, as well as a psychosocial impact (Yorkston et al., 2017). The impairment may present as inaudible or unintelligible speech, or deficits of speech control and voice-related muscular dysfunction. According to Wang (2010), the communication impairment of hypophonia is characterized by loudness variability, reduced pitch, and breathy or hoarse vocal quality. Speech-language pathologists (SLPs) are trained to diagnose hypophonia based on an extensive medical and voice history, conducting a Voice Handicap Index (VHI) 10-item questionnaire, an oral motor examination, an analysis of voice acoustics, and direct examination of laryngeal structure and 13 vocal fold movement during speech (Wang, 2010). Management PD does not have a cure, however, there are some options for pharmaceutical interventions alone or in combination with the use of therapies or assistive devices. One of the most common medications is Levodopa, a central nervous system agent. Levodopa is most used and seen as appropriate for use in the early stages of PD and aimed at the management of motor symptoms (De Bie et al., 2020). PD symptoms are caused by a decreased amount of dopamine. In combination with Carbidopa, Levodopa can be transported to the brain without being broken down, allowing Levodopa to be converted into dopamine (De Bie et al., 2020). For the purpose of this project, nonpharmacological management of hypophonia, specifically speech amplification devices, were to be explored. Behavior Therapy Behavioral treatments for hypophonia occur when an individual learns to make changes in the way they speak, compensating for the speech symptoms related to PD progression. These behavioral treatments can be temporarily effective, but many individuals fail to retain and transfer improvements beyond their experience with speech treatment in the clinic (Dykstra et al., 2015). These transfer difficulties may be related to cognitive or sensorimotor deficits associated with PD that inhibit the incorporation of new speech strategies into habitual speech. This transfer of treatment problem is a longstanding and major concern in the treatment of 14 speech in PD (Dykstra et al., 2015). Yorkston et al. (2017) interviewed 24 people with PD with mixed experiences regarding speech treatment. For example, some participants voiced satisfaction while others reported a negative experience with the drills and exercises involved in treatment related to the absence of focus on social communication. To improve speech and overall voice function, behavioral therapies can be initiated. The Lee Silverman Voice Treatment (LSVT) program works to improve vocal intensity and verbal communication by a series of behavioral interventions (Yuan et al., 2020). Alternative speech therapy programs such as SPEAK OUT! and The LOUD Crowd consist of weekly sessions for those with speech difficulty in a group setting (Behrman et al., 2020). The goal of speech directed therapies are to redirect the basal ganglia circuits to compensate for the speech control deficits that occur with PD progression. As a result of six weeks of 40-minute sessions (a total of 30), participants perceived their voice had significantly improved and was noted by higher Voice Related QoL scores (Behrman et al., 2020). In a study by Richardson et al. (2022), participants that underwent eight weeks of LSVT or Speechvive, noted a positive intervention effect as evidenced by an increase in post-treatment speech decibel, or loudness. Speechvive is a type of biofeedback device placed in the ear that vibrates when speech is under a certain decibel, triggering the user to speak louder (Richardson et al., 2022). The LSVT participants reported higher mental and physical demand during the treatment course which may help adherence and lead to improved outcomes (Richardson et al., 2022). In a four-week trial by Gustafsson et al. (2021), a biofeedback intervention with a portable voice accumulator was implemented. In this trial, a tactile vibration signal from the device was activated when the participant's voice was below a predetermined threshold. This intervention reminded the participant to increase the sound of their voice, therefore serving as an aid for hypophonia management. In participants without cognitive impairment, as determined by the Montreal Cognitive Assessment (MoCA), or a score greater than 26, a significant increase in 15 all noise ranges was noted (Gustafsson et al., 2021). Speech Amplification Devices Speech aids for hypophonia in PD also serve as an aid for symptom management. Speech amplification devices work to aid in improvement of communication and enhance QoL. An amplification device is an accommodation for an individual who has difficulty speaking loudly due to hypophonia or voice limitations, which may cause difficulty for them to be heard in noisy environments (Knowles et al., 2020). These devices consist of a microphone and a speaker, are portable or stationary, are temporarily or permanently serving as compensation for the speech deficit and counteract low speech intensity, therefore increasing audibility and speech intelligibility (Andreetta et al., 2016; Knowles et al., 2020). Speech amplification devices can serve as an effective option in hypophonia management due to voice improvement. This is noted by improved clarity and voice production working simultaneously to train respiratory muscles (Andreetta et al., 2016). These devices have been shown to improve self-awareness of speech volume, variable speech to noise ratio based on the device chosen, and improved speech intelligibility (Knowles et al., 2020). Some factors that PLwPD and hypophonia may choose against utilizing a speech amplification device may be length of time since diagnosis, age, and decline in cognitive function (Knowles et al., 2020). Although speech amplification devices have been available for decades, there are several different types that exist but have yet to be explored to their full extent by SLPs (Andreetta et al., 2016). Andreetta et al. (2016) performed a study on 11 individuals with PD and evaluated speech amplification device efficacy. The results of this study were varied due to evaluation of seven different types of amplification devices. Speech intensity, speech to noise ratio, and intelligibility were all evaluated. Those utilizing amplification devices had improved speech performance. It was noted that prescriptions based on device type were often based on patient preference, which was determined to be unrelated to adherence issues or unsuccessful use (Andreetta et al., 2016). Preference can be related to factors of portability, functional independence, and wearability discreteness (Knowles et al., 2020). Figure 1 includes four different types of amplification devices that may be utilized by those with PD and hypophonia. 16 Figure 1 Speech Amplification Devices Note. Spokeman, ChatterVox, MiniBuddy (2 versions) (left to right). (Andreetta et al., 2016). Quality of Life Perspective from PLwPD Quality Care Though this area of PD has not been researched in depth, there has been exploration focusing on health-related quality of life (HrQoL). According to Spencer et al. (2020), dysarthria and communicative participation varies due to life situations. Seeking the lived experiences of PLwPD and speech related side effect management is valuable, as it pertains to gathering information that will impact QoL and care. Education is key in PD management. Using a person- centered care model involves educating PLwPD and their carers on the disease progression and possible expectations. Early intervention for mild PD with a SLP would establish baseline 17 function before disease progression (Gilbert, 2023). Quality of Care in Primary Care Due to the speech deficits PLwPD and hypophonia encounter, an altered self-perception, difficulty compensating for long-term deficits, and a perceived reduction in communication ability can all lead to social isolation and disengagement (Andreetta et al., 2016). As the progressive nature of PD often results in a need for carers, evaluation of the physical, emotional, spiritual, and financial stressors of the PLwPD is just as important as supporting the carer or family members assisting in care provision (WHO, 2023). Therefore, a holistic person-centered approach in primary care is valuable in the management of PD. A major barrier in care for PLwPD is inadequate provider knowledge and understanding of PD along with its progression (WHO, 2023). Due to the subjectivity of PLwPD to discrimination and stigma, a conscious equal opportunity to participate in primary care, preventive services, along with expeditious diagnosis and management, should be a priority for providers (WHO, 2023). Communication and a therapeutic patient-provider relationship are keys to optimization of QoL and aid in adherence to the management plan. Healthcare providers (HCPs) for PLwPD, who also experience impacted speech, should incorporate collaboration with an interdisciplinary team of SLPs and speech therapists for management. Social Determinants of Health Social Determinants of Health (SDoH) have become a focal point for concepts to consider when providing care, especially for vulnerable populations. The United States Department of Health and Human Services (n.d.) has established five domains of SDoH and created a ten-year outlook initiative to properly address them. The domains are economic 18 stability, social and community context, education access and quality, health care access and quality, and neighborhood and built environment. Place of residence can influence neurological risks (Griffith et al., 2023), which is significant considering that PD may be caused by environmental exposures. SDoH are typically factors that are uncontrollable, but have a great impact on health care practices, access, interventions, and outcomes. Demographics influence the communicative experiences of PLwPD (McAuliffe et al., 2016), making SDoH pertinent to the plan of care. Collaborative Care While providing care in the primary care setting, HCPs need to have knowledge and understanding of PD, hypophonia, and ways to manage symptoms to improve QoL. It is valuable to know community resources such as support groups, available speech therapists or SLPs, or other treatment programs in order to connect patients experiencing such symptoms. The trajectory of PD progression is unpredictable, but it is still vital for HCPs to serve as support for pharmacological and nonpharmacological interventions (NPIs) when necessary. The goal of HCPs in the role of providing care for PLwPD and hypophonia is to implement early referrals, collaborate with an interdisciplinary team including speech specialists, and maintain a therapeutic relationship with patients to encourage open communication related to their current management plan, and discuss any barriers or negative experiences they may encounter. An additional member of the interdisciplinary team could be a neurologist (treating diseases of the brain and nervous system) or a Movement Disorders Specialist. This type of specialist is like a neurologist regarding their medical education but undergoes an additional one to two years of a movement disorders fellowship (APDA, 2020). Due to their extensive training specific to PD and related disorders, these specialists are knowledgeable on PD-specific medication and managing side effects, non-motor symptom management, and specialty 19 treatments such as deep brain stimulation or botulinum toxin injections for specific motor symptoms associated with PD (APDA, 2020). SLPs and speech therapists can collaborate as vital members of the interdisciplinary team to optimize PD management in people with hypophonia. In addition to performing the assessment and diagnosis of hypophonia, their role progresses into assisting people with dysarthria management (Wang, 2010). Their role in speech or behavioral therapies, as well as their involvement and assistance with speech amplification devices, is vital to PLwPD and hypophonia to aid in symptom management and optimization of QoL. Framework The information for this QI study was based on current available research. Personal interviews were to be the main modem of gathering data. Stakeholders included a diagnosed individual and their family, HCPs, nurses, SLPs, and social workers. A combination of services from at least two disciplines should be included in the plan for PD symptom management, which worsens as time goes on. By creating a standard process and protocol for symptom management, this assists in improving both quality of care and QoL. Dykstra et al. (2015) explains that an effective communication assessment is valuable to HCPs to aid in management of hypophonia and PD. Identifying barriers that may interfere with the management of hypophonia with speech amplification devices is vital in improving the quality of the process and initiation of care. Lewin’s Change Theory Lewin’s Change Theory consists of three stages incorporating concepts of both driving and restraining forces as well as equilibrium (Nursing Theory, n.d.). This change theory is most applicable to this QI study because of the importance of the second stage of movement, and incorporating the change as a HCP in caring for individuals with PD and hypophonia. 20 ● Unfreezing: The first stage is establishing a method in moving towards new habits or a new pattern of behavior by increasing driving forces away from the current practice or decreasing the restraining forces that affect the equilibrium. ● Change or movement: This stage is working toward a change or movement in thoughts, feelings, behavior, or practice to maximize productivity and effectiveness. ● Refreezing: The final stage is incorporating the change into practice and creating a new habit (Nursing Theory, n.d.). This stage is valuable in implementing evidence-based practice changes. Figure 2 depicts the chronological steps of Lewin’s Change Theory. Figure 2 Lewin’s Change Theory Stages Plan, Do, Study, Act (PDSA) Plan The first stage of the PDSA framework is the plan. There are three questions asked during this phase for proper project planning (see Table 3). For PLwPD and hypophonia, the appropriate questions were determined to lead to the information the team was hoping to learn. 21 Table 3 PDSA: Plan Stage as Applied to Persons Living with Parkinson’s Disease and Hypophonia Question Rationale What is the QI team trying to achieve? What will indicate an improvement in the care process? What changes could be made? • Identify burdens of voice and communication care with hypophonia • Effective and appropriate referral and follow-up (FU) with SLPs or other HCPs • Establishing an individualized nursing process to ensure quality care for PD side effect management and treatment • Creation of a cultural/race/ethnic/symptom algorithm, or step-by-step referral and FU process Do The second stage of PDSA is where implementation occurs. The information was to be gathered through interviews regarding the lived experiences of the identified population. The focus was on how SDoH impacts the unique health of individual experiences with PD, their carer’s experience, and HCPs roles in developing the optimal plan of care as it pertained to symptom management of hypophonia in PD. Through identifying barriers in device use for hypophonia, nursing and SLPs can develop processes in the greatest benefit to the PLwPD once barriers are identified. However, this was a challenge. Study The third stage was to be data analysis. Barriers were identified related to recruiting PLwPD and hypophonia meeting the inclusion criteria. According to the Agency for Healthcare Research and Quality (AHRQ), the goal is to determine whether the information gathered in the interviews will lead to improvement in the current care system for the patient population living with PD and hypophonia (2020). Since no interviews were conducted, no data was collected. At this point, returning to the plan to review and determine other strategies to recruit PLwPD and hypophonia was necessary. This occurred five times as the plan was altered to attempt to obtain 22 results with returning to revise the plan each time. Act The final stage would have been the compilation of discovered information, analysis, identification of results of the plan, and overview of each cycle (AHRQ, 2020). This stage would have allowed for data interpretation, dissemination, and further recommendations for practice change. By being able to complete a full cycle of PDSA, the themes identified, and data collected could have served as a foundation to incorporate into practice. Figure 3 demonstrates the overall framework of the continuous cycle of PDSA. Figure 3 PDSA 23 Storytelling Lived experiences are understood by storytelling as a way of thinking, dreaming, and living (Lewis & Hildebrandt, 2019). Storytelling in this project was to represent the narrative of individuals living with PD and hypophonia. Storytelling would have been valuable in this QI study because it would have provided the human perspective and allowed them to share their experiences (Lewis & Hildebrandt, 2019). These are invaluable as the individual perspectives of lived experiences are unique and can provide a foundation for the future of care provision in PLwPD. Specific Aims This project’s aim was to gather data regarding the lived experience of being diagnosed with PD and hypophonia and any use of (current, past, or present) speech amplification devices during the disease progression. If an individual used a device and stopped, the reason was going to be determined whether this was socially or economically driven, or if they thought using the device increased QoL. Barriers such as cost, transportation, and technology-related issues were also to be explored. The purpose of this project was to gather information related to the use of speech amplification devices and the impact on QoL in PLwPD and use that information to understand the experience and how HCPs might improve the experience. The data would have been used to develop a process and interventions to benefit PLwPD and the providers caring for them. The information could assist in facilitating a program to enhance provider understanding of hypophonia, the progression of PD, the role of hypophonia management, and the appropriate interventions of referral or collaboration with SLPs to aid in the holistic diagnosis and management of hypophonia. 24 Practice Problem The major problem that exists regarding lived experiences of individuals with PD and hypophonia is a gap in knowledge. There is little information on the impact on QoL in these individuals specific to speech changes, supportive therapy for symptoms of PD and hypophonia, and speech amplification device use. The QI team planned to assess these areas by asking open- ended questions in one-on-one interviews that would have allowed individuals to share their stories. Ultimately, this information would have led to discovering how advanced practice registered nurses (APRNs) and SLPs could fill gaps in care so more PLwPD and hypophonia can maintain their optimal vocal communication through disease progression. Quality Improvement (QI) Plan The QI project was initially constructed in the form of a demographic questionnaire which would have been preceded by a virtual interview with participants who had a diagnosis of PD and hypophonia. The interview questions were focused on the overall QI question: What are the lived experiences related to using a speech amplification device as a form of improved speech for people with PD/parkinsonism and hypophonia? Methods Overview This study was intended to consist of virtual one-on-one interviews of PLwPD that were also living with hypophonia. Attempts were made to recruit individuals with speech amplification device experience with assistance from volunteer SLPs associated with the SLP community liaison. Secondary recruitment consisted of reaching out to employees of speech therapy clinics, based on the recommendations and list created by the community liaison, throughout the US to distribute or display fliers. Recruitment was also attempted among support groups in several different states. Ultimately, reaching out to a willing SLP yielded some perspective on a participatory interdisciplinary team member. Refer to Appendix A for the recruitment letter for SLPs or employees of the recommended clinics. Appendix B is the 25 recruitment flyer for participants, or PLwPD. Inclusion Criteria Individuals were recruited to participate in sharing their lived experiences with PD and hypophonia based on the following criteria. ● Age 50 or older ● Able to speak, read, and write in English ● Having access to a computer, tablet, or telephone with internet access and Zoom platform ● A personal email address ● A diagnosis of PD with hypophonia ● Must have had current or past use of a speech amplification device Exclusion Criteria Individuals were excluded from project participation based on the following criteria. ● Less than 50 years of age ● Unable to speak, read, or write fluently in English ● No access to computer, tablet, or telephone with internet ● No email address ● No history of PD with hypophonia diagnosis ● No previous use of speech amplification devices Screening Screening of participants was to be conducted after they reached out from contact information provided in the recruitment flier. Individuals would have been included or excluded from the study based on the series of questions below. 26 ● Do you have a diagnosis of PD with hypophonia? ● What is your age? ● Have you ever used a speech amplification device? ● Do you have access to a telephone, computer or tablet with internet access? ● Do you speak, read, and write in English? If the individual answered no to any of the questions, or were outside the age range, they would have been thanked for their time and inclusion criteria would have been explained. If the individual was within the age range and answered yes to all of the questions, verbal consent would have been obtained for participation in the QI project. After consenting to taking 30 to 45 minutes to answer a set of interview questions regarding their lived experience with PD and hypophonia, a date and time for the in-depth interview would have been scheduled. Demographic Questions See Appendix C for a list of the demographic questions that were developed to be utilized in the project. The questionnaire would have been sent as a Qualtrics link through email for participants to fill out electronically prior to the one-on-one interview, if able. Interview Interview questions assessed disease trajectory and speech changes, speech therapy experiences, and experiences with the use of an amplification device or voice amplifier. Advisement on the development of the interview questions was performed by the community liaison to ensure completeness and accuracy of information being obtained. See Appendix D for the list of qualitative interview questions that were to be utilized to guide the one-on-one interviews. 27 Interview of SLP Interview questions assessed the SLP experiences of providing care for PLwPD, terminology used to address speech related symptoms of progressive PD, and their perspective on improving care provided by primary care and SLPs. See Appendix G for the list of qualitative interview questions that were utilized to guide the interview of participating SLPs. Ethical Considerations There were three standards of ethics included and upheld in this study: respect, beneficence, and justice. The proposal was submitted to Michigan State University’s (MSU) Institutional Review Board (IRB) for review and approved as non-research (Appendix E). Agency support from MSU’s Department of Communicative Sciences and Disorders was obtained from the community liaison (see Appendix F). Verbal consent was to be obtained to ensure that participants were aware of all aspects of the QI project. Participants would have volunteered to share their life experience with the team. Participants would have been appropriately informed of expectations and given the opportunity to remove themselves from the QI project at any point. The information to be gathered was to improve quality of care for individuals with hypophonia as a result of PD. Results The recruitment letter and flyer were sent out to a list provided by the community liaison: 1) SLPs employed by a large urban health system, 2) professional people who had previously participated in research completed by the community liaison. 3) contacts of previous conference attendees, or 4) contacts the community liaison had at PD support groups in New York (NY) and New Jersey (NJ). Additionally, a list of contacts for those conducting support groups in Michigan (MI) was obtained online from the Michigan Parkinson Foundation. See Table 4 for a breakdown of total recruitment emails sent, emails hypothetically received due to error messages returning to the sender regarding ‘invalid email addresses’, and responses received. 28 Table 4 Recruitment Results Total # Sent Total # Delivered Total # Responses Health System SLPs Previous Participants MI Support Groups NY & NJ Support Groups #: number 2 76 39 37 2 75 36 27 1 0 6 0 *Please note, all responses consisted of professionals or those conducting support groups expressing they would share the QI team’s recruitment letter and flyer with potential participants; overall yielding zero participants meeting the inclusion criteria. Summary Discussion Despite changing the plan within the PDSA cycle, no participants met inclusion criteria. The PDSA cycle was very suitable for this situation as it provided a formal structure to make multiple attempts to gather information for the project effort. The focus of the project was constantly evolving with each effort. The PDSA model was cycled 5 times in efforts to recruit participants from original criteria. After the initial cycle, attempts to recruit were sent to hospital- based SLPs with a patient base, previous connections with the community liaison, MI PD support groups, NY and NJ support groups who had previously worked with the community 29 liaison, and finally a set of questions directed toward SLPs specifically sent to a hospital system. Reflecting upon the experience, barriers that were identified were whether PLwPD knew their “soft speech” was medically termed hypophonia. Was the term ‘hypophonia’ being used by SLP? It is possible there were missed opportunities for participant recruiting based on the use of medical terminology versus layman terms? If so, this highlights the need for awareness and education of PD, symptom development, and hypophonia for PLwPD, HCPs, and SLPs. The fifth cycle of PDSA began with planning to reach out to the SLPs that the team had previously contacted to recruit PLwPD for interviews. There were no opportunities to obtain qualitative data from PLwPD and hypophonia. During the fourth PDSA cycle, one SLP reached out and provided the team the opportunity to discuss PD and hypophonia from their standpoint. The information provided to the team from the SLP explored their interaction with PLwPD and how they described hypophonia as ‘soft voice’ or ‘reduced volume’ instead of medical terminology. This SLP noted that they worked with approximately three to four patients or PLwPD per week and emphasized the importance and utilization of voice therapy more frequently than voice amplification devices. They noted that the referrals for their services typically came from ‘movement disorder specialized neurologists’ and was a rare occurrence to be referred by a primary HCP. When asked about a specific area for improvement, the SLP noted that PLwPD that are patients of speech therapy are often very involved in their exercises during therapy but don’t often practice their exercises as recommended upon discharge. This SLP noted that they would like HCPs to know the role of an SLP and the importance of a timely referral in the case of any voice, speech, or swallowing problems, especially with a diagnosis of PD. This conversation was vital regarding this QI project as it emphasized the importance of providers to be aware of the role that SLPs play in PLwPD as well as the importance of early referral for utilization of their services to maximize 30 QoL in PLwPD. Limitations There were many limitations identified throughout the process. Efforts made to minimize and adjust to the limitations were expanding to recruitment of PD support groups in NY and NJ, and contacting support groups conducted in MI. An ultimate transition to obtaining the perspective of a willing SLP regarding caring for PLwPD was explored. Due to the inability to successfully recruit participants, it could be considered that this was due to lack of diagnoses or hypophonia being referred to as “soft speech.” The recruitment flier specifically stated “hypophonia” as suggested by the community liaison SLP. This language may have deterred possible participants due to the difference in terminology used in this population (i.e. soft speech, quiet voice, reduced volume, etc.). The team also included the niche of use of a speech amplification device in which several support group leaders informed the team no PLwPD within their groups used them. Studies have shown that many people with PD and speech and voice disorders have limited access to face-to-face interventions due to factors such as mobility problems, financial issues, lack of time, distance barriers and social distancing during outbreaks of pandemics (such as COVID-19)(Mohseni et. al., 2023). Despite being provided with a list of potential participants and SLPs or support group contacts potentially willing to aid in recruitment, a significant barrier was the lack of overall response. The recruitment letter and flier were sent via email and although it was sent from an MSU email address, the email may have inadvertently been sent to ‘junk’ or ‘spam’ due to the sender being from an external organization. Also, 14 of the 154 total email addresses were invalid. After yielding only 7 responses despite various recruitment efforts over the span of three months, one being from an SLP noting they had no current patients meeting the inclusion criteria, six from PD support group leaders noting they would pass on the recruitment materials, 31 the team concluded the attempted recruitment for participants. Population Identification and Diagnosis Limitations A barrier to note was the terminology utilization mentioned above, but also the potentially the following: ● limited diagnosis of hypophonia, ● further exploration regarding the diagnosis of hypophonia may be of interest, ● the diagnosis may be overlooked or underdiagnosed, ● SLPs or speech therapy referrals are underutilized in PLwPD (to explore speech related symptoms), ● are members of the interdisciplinary team aware of the importance of their role in the diagnosis of hypophonia and consequential management of associated symptoms, ● referral to speech therapy, community resources or support groups, or use of assistive devices such as voice amplifiers, ● a lack of understanding or education to PLwPD, providers, and SLPs. PLwPD are typically followed in primary care due to the progressive nature of the disease and increased need for care coordination, especially in the later stages. Frequency of necessary follow-up may serve as a barrier in utilizing additional therapies or activities due to mobility limitations, transportation issues, fatigue, or carer availability. Inclusion Criteria Limitations Regarding the inclusion criteria, the population of PLwPD, utilizing a speech amplification device presently or in the past, and having the diagnosis of hypophonia seemed to be a niche population that the team could not reach in order to recruit participants. Potentially, the population meeting this criteria may be ‘snowbirds’ and aren’t in the areas of MI, NY, and 32 NJ during the winter months where recruitment was attempted. The winter months may have served as an additional barrier due to limitations in travel due to weather, access to care, and overall transportation. The focused population of age 50 or older may have been limited due to the barrier or a lack of understanding or altered perception of the diagnosis of PD and hypophonia, stage-specific symptoms, and management of symptoms. An additional barrier may have been the utilization of recruitment via email, the required use of Zoom for interview conduction, or limited access to technology. Implications for Practice This QI project noted several opportunities for improvement as well as usefulness in practice. Due to the lack of participants, despite extensive recruitment efforts, direction for further exploration would be to have contacts expressing interest and potential participants prior to the creation of questionnaires and project development. Further studies could be conducted regarding improvement to quality of care, coordination of care, and overall QoL for PLwPD. Many questions arose for further opportunity to explore: ● Are PLwPD being diagnosed with hypophonia or is this diagnosis overlooked? ● Are PLwPD and SLPs aware of this diagnosis as part of PD pathophysiology? ● What healthcare personnel are diagnosing PD? It is valuable for providers to be aware of the impact that hypophonia has on PLwPD to adjust the trajectory of their care, as well as initiation and involvement of an interdisciplinary team. The responsibility of the provider managing care for PLwPD should consist of a thorough explanation of the progressive nature of PD and how symptoms may cause an impact on QoL, specifically hypophonia. To ensure patient understanding of their diagnosis, multiple terms describing hypophonia, or collectively hypokinetic dysarthria, should be used such as muffled speech, low intensity speech, quiet speech, etc. A teach back method could be utilized as a 33 measurable way to ensure patient understanding. Although medical terminology is utilized in professional practice when talking amongst other providers, this verbiage should be introduced to PLwPD as their condition may consist of any or all of these speech descriptors. An additional responsibility includes an early referral to speech therapy or an SLP whose role is to aid in diagnosis of hypophonia as well as provide strategies and interventions to overcome or combat the speech-specific symptoms of PD. Education regarding available community resources should also be included in the plan of care to provide PLwPD knowledge of and access to local support groups or programs such as SPEAK OUT! or The LOUD Crowd. Frequent monitoring of this progressive condition is imperative to the QoL of PLwPD. Recommendations for next steps would consist of further QI projects exploring the lived experiences of PLwPD, how speech symptoms impact QoL, and their perspective on what they value in a HCP and person-centered management of PD. 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European Journal of Neurology, 27(10), 1957–1970. https://doi.org/10.1111/ene.14399 Appendix A 40 Recruitment Letter Appendix B 41 Recruitment Flyer Appendix C 42 Individual Characteristics: Demographics Questionnaire/Qualtrics Survey What is your current age? ● 50 to 64 years of age ● 65 to 84 years of age ● 85 to 99 years of age ● 100 years of age and older What was your sex assigned at birth? ● Male ● Female What category below do you consider best describes yourself? ● Straight or heterosexual ● Gay ● Lesbian ● Bisexual ● Transgender ● I use a different term: _______________________ ● I don’t know ● I prefer not to answer What is your ethnicity? ● American Indian or Alaska Native ● Asian ● Black or African American ● Hispanic or Latinx ● Native Hawaiian or Other Pacific Islander ● White ● Other: _______________________ What is your highest level of education obtained? ● Some elementary school ● Some high school ● High school graduate/GED ● Trade school ● Some college (community or 4 year) ● Associates degree ● Bachelor’s degree ● Master’s degree ● Doctorate degree ● Other: _______________________ Which of the following describes your personal relationship? ● Single ● Married 43 ● Separated ● Divorced ● Widowed ● Partner ● Other: _______________________ Who do you currently live with? ● Alone ● Spouse ● Partner ● Friend ● Children ● Parent ● Other family member: ● Other: _______________________ What is your current living environment? ● Single house ● Apartment ● Condominium ● Senior housing ● Continuing Care Retirement Community ● Assisted living facility ● Adult foster care ● Nursing home ● Hospice facility ● Other: _______________________ How many years ago were you diagnosed with Parkinson’s disease? ● 1 to 2 years ● 3 to 5 years ● 6 to 8 years ● 9 years or more ● Do not recall Have you been diagnosed with a speech or language impairment? ● Yes ● No Have you been diagnosed with a hearing impairment? ● Yes ● No When did you first notice your voice changing? ● Less than 1 year ● 1 to 2 years ● 3 to 5 years ● 6 to 8 years ● 9 years or more ● Do not recall If you currently use a speech amplification device, how many years have you been using it? 44 ● Less than 1 year ● 1 to 2 years ● 2 to 3 years ● 4 to 5 years ● 5 or more years ● Do not recall ● N/A (I am not a current user, see next question) If you do not currently use a speech amplification device, how long has it been since you used a device? ● Less than 1 year ● 1 to 2 years ● 2 to 3 years ● 4 to 5 years ● 5 or more years ● Do not recall ● N/A (I currently use a speech amplification device) How many types of speech amplification devices have you tried to use? ● 1 ● 2 ● 3 ● 4 or more ● Do not recall If there is other information you would like us to know about you, please write it out in the box below. You can write up to 250 characters in the box. Thank you for participating! Appendix D 45 Speech Amplification Device Use in PD and Impact on Quality of Life Interview Questions In this interview, I will ask you questions about your experience with Parkinson’s, speech changes, and your amplification device. But first, tell me a little about your journey with your speech since your PD began. Probe 1: Disease trajectory and speech changes 1. Can you describe how your speech has changed since your PD diagnosis? 2. Could you tell me about any challenges you’ve experienced with your speech since your PD symptoms first appeared? 3. How, if at all, have your speech changes affected your ability to participate in your day-to-day work or hobbies? Potential follow up: Tell me what kinds of situations you found your speech changes affecting your conversations and interactions the most (home, work, social gatherings, supermarkets, restaurants). 4. Please describe any feelings you can recall, if any, that you experienced upon first noticing voice changes. Potential follow up: …did you ever feel socially isolated or left out? …did you ever feel depressed? …did you ever feel distressed religiously or spiritually? Probe 2: Speech therapy experiences 5. We’ll talk about your amplification device in a moment, but first, tell me about your overall experiences with speech therapy. 6. When & why did you first decide speech therapy was something you were going to pursue? Potential follow-ups to probe if not apparent: Do you recall if your speech therapist had you in a program like LSVT-LOUD or SPEAK- 46 OUT? Did you participate in any group therapy? How long did you see a speech therapist? Did you ever take any medications for PD? What other kinds of treatment or management have you tried for your PD symptoms in addition to speech therapy (such as physical therapy, occupational therapy, exercise groups, boxing, singing groups, etc.)? Probe 3: Speech amplification device experiences 7. Tell me a little about your amplification device: what kind of device is it, and how do you use it? 8. Please describe your overall experience with your speech amplification device. 9. What has it been like for you? Potential follow ups: ● What are some things that you like about using your device, if any? ● What are some things you don’t like about using your device, if any? ● Tell me about any challenges you have faced that made the device difficult to use. ● Do you still use your device? ○ If yes: ■ Tell me about when you use your device? ■ What kinds of situations and contexts? ○ If no: ■ How long did you use the speech amplification device? ■ Could you tell me more about what stopped you from using the device altogether? ■ Please describe any feelings you can recall, if any, prior to trialing a speech amplification device. 47 Potential follow up: What kinds of changes, if any, did you notice in how you felt or your mood after using the speech amplification device? …did you ever feel socially isolated or left out? …did you ever feel depressed? …did you ever feel distressed religiously or spiritually? 10. When did you first hear about amplification devices as an option for treating your speech? Tell me about what that was like for you. Potential follow ups: ● Who first told you about these kinds of devices? ● How long after you had noticed changes to your speech was it offered? ● Did you try more than one device? ● What were your first thoughts when you heard about this option? ● What were your first thoughts when you tried a device for the first time? ● Tell me about any difficulties, if any, that you had with accessing care/resources in terms of a provider, neurologist, medications, or therapies. (Getting to appointments, availability of specialists, transportation to the pharmacy or therapy) 11. Tell me about the education or information you were provided with on using the speech amplification device, if any. 12. Could you tell me more about any concerns you had in regard to obtaining or paying for the speech amplification device, if any? 13. Could you tell me more about the people that provided you with the most support during the time you were using the speech amplification device? 14. What kinds of changes, if any, did you notice in your communication when using an 48 amplification device? Potential follow up: ● Tell me about how it impacted your life (positives/negatives/quality of life/communication/interpersonal relationships/maximize social outings)? 15. What is one thing, if anything, you wish your speech therapist could have done differently for you relating to your speech management (earlier referral, connection to resources, etc.)? Final question: 16. Is there anything we have not discussed about your communication or your device that you think is important for me to know? Appendix E MSU IRB Approval Document 49 50 Community Liaison Support Letter Appendix F 51 Appendix G 52 SLP Questionnaire 1. Have you worked with patients, with Parkinson's disease (PD) or not, that are experiencing hypophonia? Describe your level of involvement and process of diagnosing hypophonia/hypokinetic dysarthria. 2. Are speech amplification devices common in your practice as a treatment modality? 3. Do you receive referrals for speech pathology secondary to PD? If so, who do these referrals come from? (i.e. Primary Care Provider/Neurology) 4. What would you identify as an area of improvement for the care of persons living with Parkinson's disease (PLwPD) & hypophonia patients? Do you have a large population of these patients? 5. Are PLwPD adherent to SLP services? 6. Do you use the term hypophonia or do you explain it as “soft speech?” 7. What would you want NPs working in primary care with PD patients to know about why/when they should refer patients to you?