Adapting and Testing the Care Partner Hospital Assessment Tool for Use in Dementia Care: Protocol for a 2 Sequential Phase Study

Background Research and policy demonstrate the value of and need for systematically identifying and preparing care partners for their caregiving responsibilities while their family member or friend living with dementia is hospitalized. The Care Partner Hospital Assessment Tool (CHAT) has undergone content and face validation and has been endorsed as appropriate by clinicians to facilitate the timely identification and preparation of care partners of older adult patients during their hospitalization. However, the CHAT has not yet been adapted or prospectively evaluated for use with care partners of hospitalized people living with dementia. Adapting and testing the CHAT via a pilot study will provide the necessary evidence to optimize feasibility and enable future efficacy trials. Objective The purpose of this paper is to describe the study protocol for the adaptation and testing of the CHAT for use among care partners of hospitalized people living with dementia to better prepare them for their caregiving responsibilities after hospital discharge. Methods Our protocol is based on the National Institutes of Health Stage Model and consists of 2 sequential phases, including formative research and the main trial. In phase 1, we will use a participatory human-centered design process that incorporates people living with dementia and their care partners, health care administrators, and clinicians to adapt the CHAT for dementia care (ie, the Dementia CHAT [D-CHAT]; stage IA). In phase 2, we will partner with a large academic medical system to complete a pilot randomized controlled trial to examine the feasibility and estimate the size of the effect of the D-CHAT on care partners’ preparedness for caregiving (stage IB). We anticipate this study to take approximately 60 months to complete, from study start-up procedures to dissemination. The 2 phases will take place between December 1, 2022, and November 30, 2027. Results The study protocol will yield (1) a converged-upon, ready-for-feasibility testing D-CHAT; (2) descriptive and feasibility characteristics of delivering the D-CHAT; and (3) effect size estimates of the D-CHAT on care partner preparedness. We anticipate that the resultant D-CHAT will provide clinicians with guidance on how to identify and better prepare care partners for hospitalized people living with dementia. In turn, care partners will feel equipped to fulfill caregiving roles for their family members or friends living with dementia. Conclusions The expected results of this study are to favorably impact hospital-based care processes and outcomes for people living with dementia and their care partners and to elucidate the essential caregiving role that so many care partners of people living with dementia assume. Trial Registration ClinicalTrials.gov NCT05592366; https://clinicaltrials.gov/ct2/show/NCT05592366 International Registered Report Identifier (IRRID) PRR1-10.2196/46808

AGCD-3 FIELDS, B mentors, Drs. Farrar-Edwards, Werner, and Shah, and Mr. Hetzel, all of whom have experience mentoring trainees. This will be complemented by content and mentoring expertise from Drs. Schulz and Gilmore-Bykovskyi. Collectively, this team will provide an outstanding training environment that will allow Dr. Fields to fill critical gaps in her knowledge and skill set relating to the study of hospital-based care processes and outcomes for patients living with ADRD and their care partners. Her training goals are to develop skills in (1) participatory human-centered design principles, (2) hospital-based ADRD care delivery, (3) clinical trial design and statistical analysis, (4) ethical and regulatory standards in ADRD research,and (5) professional skills in team science and scientific leadership. Achieving these goals will strengthen her scholarly activities, establish important collaborations, and acquire critical data that will ensure her successful transition to independence. To this end, Dr. Fields' proposed research plan builds directly on her prior work developing and validating the Care Partner Hospital Assessment Tool (CHAT). Guided by the widely used and effective decision-support model of Screening, Brief Intervention and Referral to Treatment (SBIRT), the CHAT applies a sequential screening and referral pathway that 1) identifies care partners and their preferences for inclusion in the patients' hospital care and 2) tailors referrals to address their stated preferences and unmet needs for post-discharge preparedness. The SBIRT model was designed to adapt flexibly to different health conditions and contexts, thus enabling the adaptation of the CHAT to facilitate the inclusion and preparation of care partners of patients living with ADRD. Therefore, the purpose of this proposal is to adapt CHAT for care partners of hospitalized patients living with ADRD (CHAT-AD) and evaluate its feasibility and potential efficacy in a pilot randomized clinical trial. Findings from this study, in combination with the career development plan, will enable Dr. Fields to launch an independent program of research that aims to (1) improve hospital-based care processes and outcomes for patients living with ADRD and their care partners, and (2) elucidate the essential caregiving role that so many care partners of patients living with ADRD assume.

PUBLIC HEALTH RELEVANCE:
Lack of caregiving preparedness is prominent and persistent among care partners of patients living with Alzheimer's disease and related dementias (ADRD) and associated with increased risk for adverse clinical outcomes for patients living with ADRD, and increased levels of burden, depression, and morbidity for care partners. Engaging key stakeholders to adapt the standardized Care Partner Hospital Assessment Tool for hospital-based dementia care will expand its potential reach. Further, findings from this pilot randomized controlled trial will enable future efficacy trials to advance the refinement and implementation of the decision-support tool that can enhance caregiving preparedness to improve health outcomes after hospital discharge.
DISCLAIMER: Please note that the following critiques were prepared by the reviewers prior to the Study Section meeting and are provided in an essentially unedited form. Although there is opportunity for the reviewers to update or revise their written evaluation, based upon the group's discussion, there is no guarantee that individual critiques have been updated after the discussion at the meeting. Therefore, the critiques may not fully reflect the final opinions of the individual reviewers at the close of group discussion or the final majority opinion of the group. Thus, the Resume and Summary of Discussion is the final word on what the reviewers considered critical at the meeting. This is a new K23 application, submitted by Dr. Fields, Assistant Professor in the Occupational Therapy Program, Department of Kinesiology at UWM. The project is entitled, "Adapting and Testing the Care Partner Hospital Assessment Tool (CHAT) for Use in Dementia Care". The candidate has a PhD in Occupational Therapy and has completed a post-doctoral fellowships in Health Policy and Caregiving Research and Health Services Research. She is also an affiliate faculty member in the School of Nursing and Wisconsin Alzheimer's Disease Research Center (ADRC) and executive committee member of the Wisconsin Institute for Healthcare Systems Engineering. Briefly, the proposed research builds upon the candidate's prior work developing and validating the Care Partner Hospital Assessment Tool (CHAT), which applies a screening and referral pathway that 1) identifies care partners and their preferences for inclusion in the patients' hospital care and 2) tailors referrals to address their stated preferences and unmet needs for post-discharge preparedness. The work proposed adapts CHAT for care partners of hospitalized patients living with ADRD (CHAT-AD) and evaluates feasibility and potential efficacy in a pilot randomized clinical trial (RCT). The goal is to apply for R01 funding for a full scale RCT of the CHAT-AD. Her training goals are to develop skills in (1) participatory human-centered design principles, (2) hospital-based ADRD care delivery, (3) clinical trial design and statistical analysis, (4) ethical and regulatory standards in ADRD research, and (5) professional skills in team science and scientific leadership. The application includes an appropriate training plan to accomplish these goals. She is supported by an excellent, highly qualified and committed team of mentors and advisors. Excellent institutional environment and support for the candidate. Overall, there is high enthusiasm about the Candidate; the application includes a few minor concerns related to the RP that are likely addressable.

Candidate: Strengths
• Candidate has PhD in Occupational Therapy, Board Certified in Gerontology by the American Occupational Therapy Association (1 of only 79 in US). Therapists.

Career Development Plan/Career Goals and Objectives: Strengths
• Overarching career goal is to establish an independent and NIH-funded research program focused on improving hospital-based care processes and outcomes for patients living with ADRD and their care partners. • Strong educational and training background, yet clearly justifies additional training need to address identified gaps: including experience conducting studies that incorporate participatory • Plans for multi-site R01 level study to determine the efficacy of a standardized decision-support tool on caregiving preparedness of care partners and service utilization of patients living with ADRD. The R01 will be designed and powered to detect differences in adverse health and service utilization outcomes, such as urinary tract infections and 30-day hospital readmissions.

Weaknesses
• Unclear if intent is to attend and present at all 4 national organization meetings every year, which would likely be too much. • The amount of effort focused on career development, research, other clinical or teaching duties is not made explicit in the application.

Research Plan: Strengths
• Extremely important area of research; compelling background evidence and policy support for intervention development in this area. • Preliminary work, support by R03, developed and validated a standardized decision-support tool to facilitate the timely inclusion and preparation of care partners of cognitively unimpaired adult patients during their hospitalization. The Care Partner Hospital Assessment Tool (CHAT) was found to have strong content validity and is endorsed as feasible and appropriate by clinicians and care partners in the hospital setting. • The CHAT design follows the clinical decision-support model of screening, Brief Intervention and Referral to Treatment (SBIRT), and was built upon an assessment framework recommended by the National Center on Caregiving at the Family Caregiving Alliance. The tool uses 22 items all of which have a content validity index at or above the acceptable 78% cut point and a scale-content validity index of 85%, based upon surveys with experts in gerontology, caregiving, and health services. Feasibility of the CHAT was also supported by qualitative assessment with health care administrators, clinicians, and care partners. • The goal of this application is to adapt the CHAT for care partners of patients with ADRD.
• The work proposed involves 2 Aims and is guided by the System Engineering Initiative for Patient Safety (SEIPS) 2.0 conceptual model. • Aim 1 Employs an iterative human-centered design process to adapt CHAT for care partners of hospitalized patients living with ADRD (CHAT-AD). By forming two stakeholder design teams, one team comprised of previously hospitalized patients with ADRD and their care partners (N=7 dyads) and the second healthcare system administrators and clinicians (N=7). Each will complete 5 co-design videoconferences, 90 minutes, audio recorded for transcription. • Through iterative steps, the CHAT will be adapted becoming the CHAT-AD, which will include caregiving domains unique to ADRD care partners and discipline-specific. • Treatment to meet the preparation needs of care partners.
• Aim 2 will conduct a pilot RCT to evaluate the feasibility and estimate the size of the effect of the CHAT-AD compared to usual care. Primary outcome caregiving preparedness and secondary outcome satisfaction with care will be measured pre and post in comparison to the control group. Feasibility measures will include recruitment, attrition, safety, adherence, and implementation satisfaction. • Partnering with the Acute Care for Elders (ACE) program the study will recruit over 2.5 years 128 eligible care partners of hospitalized patients living with ADRD, who will be randomized into either the CHAT-AD plus usual care or usual care-only groups. • Sample size estimate appears to provide adequate power.

Weaknesses
• Very little race/ethnic diversity in the study sample. While the sample is local and thus feasible, it is strongly recommended increasing efforts to add diversity, especially in preparation for the R01 application. • While the ACE team is advised not to use the CHAT-AD with control group patients, bias may be created by training. Would consider the possibility of baseline/control measurement period prior to training and starting the intervention, or other ways to minimize this bias. This is also an important design issue to consider and prepare for considering the R01 submission. • The team may want to consider enrollment of eligible patients not cared for by the ACE team model as usual care. While achieving an effect in the setting of ACE care would be a robust finding, ACE team care is not available at many hospitals and the effect may be larger in settings without it. • Caregiving context characteristics are only measured at Time 1 and could change significantly post-discharge at Time 2. • The planned R01 will be designed and powered to detect differences in adverse health and service utilization outcomes, such as urinary tract infections and 30-day hospital readmissions but these outcomes are not being assessed in Aim 2. Could data from the electronic health record (HER) be leveraged for longer term follow-up? • A component of the background justification is that care partner who are in adequately prepared are at high risk of experiencing excess burden, chronic stress, and depression. The team could consider exploratory/secondary measures of these constructs as well.

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s): Strengths
• Excellent mentoring team with established relationship with the candidate and with each other.
• Strong and personalized letters of support from mentors.

Weaknesses
• Big team of mentors, collaborators and consultants will require careful management to be used effectively and efficiently. Some details of meetings with and managing input from this group are limited.

Environment: Strengths
• Strong letter of support from the Department Chair, assuring 75% time for the research and training proposed, support for her primary mentor's time, and start-up funds to support her research. • Start-up funds to establish candidate's Geriatric Health Services Research Laboratory, which support hiring a lab coordinator, graduate research assistant and student who will be assisting with subject recruitment, enrollment, and data management for this application. Overall Impact: Dr. Fields holds a PhD in OT and is a tenure-track Assistant Professor in the Department of Kinesiology. She has intramural and extramural grants, and over 28 publications with 12 first author and 4 senior authors. Her career training goals are appropriate for K23 award. Her focus is on caregivers of patients with ADRD. She has 2 Aims in her RPs. One to develop CHAT-AD, and to conduct a pilot study using CHAT-AD to prepare unpaid caregivers of ADRD patients for home care. The mentors and environment are outstanding and meets her needs. • She has 28 peer reviewed paper with 12 first author and 4 senior author.
• She has 6 intramural pilot grants, a foundation grant, National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) grant, and NIA R03 on aging and caregiving research. • She has existing relationships with her mentor, co-mentors, collaborators, and consultants. Weaknesses • None noted.

Career Development Plan/Career Goals and Objectives: Strengths
• She already has knowledge and skill set in caregiving, gerontology, methods of evaluating health services delivery, and clinical decision-support tool development. She Aims to develop geriatric health services with focuses on ADRD caregiving. • Funding for 5 years at 75% time.
• The training Plan via coursework/self-study/seminars involve areas of 1)Participatory humancentered design, 2) hospital-based ADRD care, 3) clinical trial design and statistical analysis, 4) ethical and regulatory issues, especially for ADRD research, 5) leadership, management, presentation, and mentoring skills. Weaknesses • None noted.

Research Plan: Strengths
• The goals include development of decision-support tools to facilitate the inclusion and preparation of unpaid family member or friend care partners in hospital-based care; and