ABSTRACT
BACKGROUND: Approximately 7.5 million older adults are homebound, who have difficulty and/or need assistance to leave their homes. In this growing population, the prevalence of people living with dementia (PLWD) is approximately 50%. Current dementia care models in the USA were developed for traditional office-based primary care and have not been tailored to home-based primary care (HBPC) delivery models. Literature has shown that office-based collaborative interventions can improve caregiver outcomes including caregiver stress, well-being, and morbidity and patient outcomes including improved quality of life and reduced emergency department visits (Possin KL, Merrilees JJ, Dulaney S, Bonasera SJ, Chiong W, Lee K, JAMA Int Med 179:1658, 2019). To date, the evidence for HBPC dementia interventions is lacking. Though HBPC has demonstrated benefit in homebound older adults, there is limited literature on the effects of HBPC on persons living with dementia (Nguyen HQ, Vallejo JD, Macias M, Shiffman MG, Rosen R, Mowry V, J Am Geriatr Soc 70:1136-46, 2021). Our goal is to develop a HBPC-focused dementia care intervention that integrates the components of two previously developed dementia care models and test the feasibility of implementing it in HBPC practices to improve the quality of life and wellbeing of homebound PLWD and their caregivers. METHODS: We will first conduct qualitative focus groups at two HBPC practice sites, one in the Southeast and one in Hawaii in order to obtain preliminary feedback on the proposed intervention. At each site, there will be one focus group with caregivers of PLWD and another with HBPC clinicians and staff to help develop and refine our intervention. We will then conduct an open-pilot trial of the refined intervention at the two HBPC practices. A total of up to 25 patient/caregiver dyads will be recruited at each site (N = 50 total). Outcomes measured through pre-and-post assessments and exit interviews will include (a) feasibility for the caregiver to engage with and complete baseline assessments and access educational materials and community resources and (b) feasibility for the practice to identify potential caregivers/patients, assess eligible patient/caregiver dyads, use patient and caregiver assessments, recruit patient/caregiver dyads, recruit racial and ethnic minorities, use care modules, and engage with the tele-video case conference, (c) net promoter score, (d) acceptability of the intervention to caregivers and patients to participate in the intervention, (e) caregivers feeling heard and understood, and (f) caregiver well-being. DISCUSSION: Testing the feasibility and acceptability of the adapted intervention in these two HBPC practices will provide the basis for future testing and evaluation of a fully powered intervention for PLWD and their caregivers cared for in HBPC with the goal of disseminating high-quality and comprehensive dementia-care focused interventions into HBPC practices. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov NCT05849259 in May 2023.
ABSTRACT
Introduction: A growing number of patients with serious illness who would benefit from palliative care are part of ethnoracial minority groups. Nevertheless, large disparities in provision of palliative services exist for minoritized populations. Furthermore, there is a relative dearth of palliative care research focused on minority groups and how best to provide high-quality, culturally tailored palliative care. The aim of this narrative review is to summarize the existing literature regarding palliative care clinical trials in underrepresented minority populations, describe methodological approaches, and provide guidance on future palliative care-focused clinical trials. Methods: We used the Scale for the Assessment of Narrative Review Articles (SANRA) and Cochrane's guidelines on conducting reviews. We used PubMed and Clinicaltrials.gov to review published, full-text articles or protocols (1950-2022), and limited to palliative care interventions focused on ethnoracial minority populations. We included randomized clinical trials (RCTs), including pilot and feasibility trials, protocols of RCTs, and studies that report RCT methodology. Two reviewers independently assessed eligibility. Results: Our search yielded 585 publications; of these, 30 met the full-text review criteria and 16 studies met our criteria for inclusion. We deemed nine articles as having low risk of bias and four as having high risk of bias. Discussion: Commonly used methodologic approaches for clinical trials in underrepresented minority populations included the following: the use of written and visual materials that were no higher than a sixth-grade reading level, the use of patient and lay health navigators, bilingual and multicultural study staff and study materials, race-concordant staff, the option of in-person and virtual visits that accommodated the patient and family's schedule, recruitment from faith communities, and the use of community-engaged research principles. Future palliative care clinical trials should expand on the strategies described in this article, adopt effective strategies currently used in nonpalliative care interventions, and innovate around the principles of community-engaged research.
ABSTRACT
BACKGROUND: Alzheimer disease and related dementias are debilitating and incurable diseases. Persons with dementia and their informal caregivers (ie, dyads) experience high rates of emotional distress and negative health outcomes. Several barriers prevent dyads from engaging in psychosocial care including cost, transportation, and a lack of treatments that target later stages of dementia and target the dyad together. Technologically informed treatment and serious gaming have been shown to be feasible and effective among persons living with dementia and their care partners. To increase access, there is a need for technologically informed psychosocial interventions which target the dyad, together in the home. OBJECTIVE: This study aims to develop the toolkit for experiential well-being in dementia, a dyadic, "bio-experiential" intervention for persons with dementia and their caregivers. Per our conceptual model, the toolkit for experiential well-being in dementia platform aims to target sustained attention, positive emotions, and active engagement among dyads. In this paper, we outline the protocol and conceptual model for intervention development and partnership with design and development experts. METHODS: We followed the National Institutes of Health (NIH) stage model (stage 1A) and supplemented the model with principles of user-centered design. The first step includes understanding user needs, goals, and strengths. We met this step by engaging in methodology and definition synthesis and conducting focus groups with dementia care providers (N=10) and persons with dementia and caregivers (N=11). Step 2 includes developing and refining the prototype. We will meet this step by engaging dyads in up to 20 iterations of platform ß testing workshops. Step 3 includes observing user interactions with the prototype. We will meet this step by releasing the platform for feasibility testing. RESULTS: Key takeaways from the focus groups include balancing individualization and the dyadic relationship and avoiding confusing stimuli. As of September 2023, we have completed focus groups with providers, persons with dementia, and their caregivers. Additionally, we have conducted 4 iterations of ß testing workshops with dyads. Feedback from focus groups informed the ß testing workshops; data have not yet been formally analyzed and will be reported in future publications. CONCLUSIONS: Technological interventions, particularly "bio-experiential" technology, can be used in dementia care to support emotional health among persons with a diagnosis and caregivers. Here, we outline a collaborative intervention development process of bio-experiential technology through a research, design, and development partnership. Next, we are planning to test the platform's feasibility as well as its impact on clinical outcomes and mechanisms of action. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52799.
