The main purpose of this intervention study is to test if the community health worker (CHW)-led care transition support intervention is feasible and acceptable to the persons living with dementia (PLWD)'s caregivers, and other healthcare providers. Main hypotheses of the study are: 1. the CHW interventionist will adhere to the intervention protocol with the score of 80% or higher on the intervention fidelity checklist throughout the intervention delivery period; 2. caregiver participants in the intervention group will rate the intervention, and the CHW interventionist to be helpful and satisfactory at the end of the intervention; 3. intervention feasibility (as measured by intervention completion rate, i.e., number of participants completing the telephone sessions with the CHW coach, and participant assessment completion rate, i.e., number of participants completing each study assessment at baseline, 6, 12 weeks) will be at equal to or higher than 80%; and 4. intervention participants - patient and caregiver - outcomes will improve at post-discharge Week 12 follow up from baseline and Week 6.
This study is a single-site, single-arm feasibility study with hospitalized person living with dementia (PLWD) and their family caregiver dyads receiving the community health worker (CHW)-led Care Transition Intervention to obtain preliminary data on the intervention's acceptability, feasibility, and potential efficacy. In addition to evaluation PLWD and caregiver outcomes, multiple stakeholders from two hospitals (Dell Seton Medical Center and Ascension Seton Medical Center Austin) will be interviewed focusing on intervention relevance for healthcare system and provider stakeholder priorities and feasibility and acceptability of integration into everyday workflows. Mixed methods (individual interviews, chart reviews) study will be conducted to gather views of various stakeholders at two hospital sites including PLWD and family caregivers, frontline providers and care staff, administrators, and information technology staff. Of the two hospitals, Dell Seton Medical Center and Ascension Seton Medical Center Austin, Dell Seton Medical Center (DSMC) will be the main study site where the intervention and recruitment of dyads will take place. At Ascension Seton Medical Center Austin (ASMCA), staff will be interviewed to assess the feasibility and acceptability of the intervention to determine if future implementation at ASMCA is possible. PLWD and caregiver target enrollment for this study is 80 English- or Spanish-speaking family caregivers and 80 of their care recipients who meet the eligibility criteria. The intervention will be led by a bilingual (English and Spanish speaking) CHW who is trained in the intervention. The intervention process starts with the family assessment by the CHW, which identifies primary and secondary caregiving stressors, resources and social support availability, and needs for support as related to social determinants of health, dementia education, care navigation, caregiver health and burden. Closer to discharge, the CHW will again make contact with the family caregiver to review the post-discharge care plan and to help the family caregiver develop a plan for post-discharge care. Dyads will receive a curated individualized dementia caregiving toolkit. All meetings with the caregiver during patient's hospitalization will be done in person, via telephone or via zoom, whichever the caregiver prefers. Within the first week of discharge, the CHW will meet via telephone or Zoom with the dyad to review the goals, additional support needs such as care navigation, access to social services, and any other concerns. During the first month after discharge, the CHW will continue to provide weekly or bi-weekly telephone/zoom check-ins as needed for coaching, focused dementia and caregiving education, or navigation support, and provide approximately four additional bi-weekly check-in sessions with the caregiver for the following two months. Each telephone check-in session will last approximately 30-45 minutes and will include a brief review of the goals, a check in regarding the well-being of caregiver and PLWD and will address any questions or needs regarding post-discharge care navigation. Caregiver study participant assessments will be conducted by telephone at baseline, at around 6 weeks (4-6 weeks depending on the availability of the caregiver), and at around 12 weeks (12-14 weeks depending on the availability of the caregiver) post-discharge. The GRA will also conduct chart reviews to gather additional patient outcome data. The primary outcomes of this pilot trial are acceptability, feasibility, and fidelity. Interviews will be conducted with the CHW interventionist, palliative care team members, other primary care team members, information technology (IT) staff and/or other relevant staff at both study sites (DSMC and ASMCA) using in-depth interviews to explore acceptability and feasibility of the intervention. In addition, interviews will be conducted with key stakeholders and informants before and after the intervention is implemented. The goal of these interviews is to identify any additional challenges or priorities stakeholders experience during transitions of care that our intervention needs to consider. Stakeholders will include hospital staff from two sites (DSMC and ASMCA), content experts on dementia and caregiving (e.g., clinicians, service providers, scholars on this topic area), community organization providers for older adults and people living with dementia or their families, and formal or current dementia caregivers. Participants may be asked to participate in in-depth interviews multiple times, before the intervention is implemented, during the implementation period, and after the intervention has been implemented. Using a semi-structured interview (in person, phone, or zoom, whichever the participant prefers) which will take approximately 30-60 minutes. To analyze the acceptability and feasibility of the protocol and barriers to recruitment and retention as well as systemwide implementation, analytic techniques for mixed methods study will be used such as content analyses and descriptive methods. All quantitative data analyses (e.g., descriptive, correlation,) will be conducted with SPSS v24 and R software. All qualitative interviews will be digitally-recorded and will be transcribed verbatim by a professional transcription service, and uploaded into Dedoose qualitative analysis software. A coding scheme and a codebook will be developed; codes will consist of externally-generated codes based on a predetermined conceptual framework, and internally-generated codes that emerge from the analysis with focus on codes reflecting potential difficulties with the intervention; opinions about the length and number of sessions; the delivery method; stakeholder priorities; implementation challenges and barriers; etc. Member checking will be ongoing from interview to interview. To corroborate findings and establish trustworthiness, an audit trail will be kept and co-investigators will be convened to provide critical feedback on the emerging codes. Data will be reviewed within and across coded texts in order to extract converging themes and reach consensus on principal themes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
34
The CHW conducts a family assessment, which identifies caregiving stressors, social support, and needs as related to social determinants of health, dementia education, care navigation, caregiver health and burden. Closer to discharge, dyads receive an individualized dementia caregiving toolkit including the post-discharge care planning checklist, tracking sheets for patient medications, tests, and procedures, and info on local resources. All meetings will be done in person, telephone, or zoom. Within one week of discharge, the CHW meets the dyad via phone or Zoom to review their goals and to identify any additional needs for coaching, education, or navigation support. In the first month after discharge, the CHW provides weekly or bi-weekly check-ins. For the next two months, the CHW provides about four additional bi-weekly check-in sessions. Each check-in session will last approximately 30-45 minutes. The exact number of meetings will be determined by need and caregiver availability
Dell Seton Medical Center
Austin, Texas, United States
Caregiver Acceptability
Participants will be asked about acceptability using 7 items with Likert type scales which were developed by the research team to assess: (1) if the caregiver liked meetings with CHW (1=strongly dislike, 5=strongly like); (2) how much efforts the caregiver had to put in meeting with CHW (1=no effort at all, 5=huge effort); (3), if the CHW support was fair (1=very unfair, 5=very fair); (4) if the CHW support improved the patient experience (1=strongly disagree, 5=strongly agree); (5) if it was clear to the caregiver how the CHW support will improve the caregiver's ability to care for the patient (1=strongly disagree, 5=strongly agree); (6) how confident the caregiver was in participating meetings with the CHW (1=very unconfident, 5=very confident); and (7) overall rating of the acceptability of the intervention in support the caregiver (1=completely unacceptable, 5=completely acceptable).
Time frame: At post-discharge Week 12 follow up.
Study Feasibility
Feasibility will be assessed by study enrollment rate (percentage of eligible persons enrolled in the study), and participant assessment completion rate (number of participants completing each study assessment at baseline, Post-discharge Week 6 and Post-discharge Week 12 follow-up). Consistent with other pilot intervention studies, 25% rate of enrollment, equal or higher than 70% completion rates for study assessments will be considered as evidence of feasibility.
Time frame: Assessing feasibility begins with their enrollment (at Baseline) and ends with their final scheduled visit with the CHW (at Post-discharge Week 12 follow-up).
Fidelity
We will select approximately 20% of participants' interview recordings (at least one initial assessment and at least one follow-up CHW sessions), review and apply the fidelity checklist. The fidelity assessment was developed by the research team to evaluate CHW performance across key competencies using a structured scale. Nine items assess the CHW's skills and action including ability to accurately explain their role, convey a positive, non-judgmental attitude, active listening skills (e.g., reflection, validation, summarizing) and supportive responses to emotions are measured (scored 3 if consistent/always, 2 if inconsistent/sometimes, and 1 if absent/rarely). Four items assess presence of CHW following the crisis intervention model elements, e.g., facilitating the patient's immediate needs (scored 3 if present, 0 if absent). Assessment and follow-up form completeness is scored with 4 if 80% or higher, and 0 if less than 80%.
Time frame: CHW Initial Assessment Meeting (within the first week of enrollment), 1st CHW Follow-Up Meeting (within 4 weeks of the initial assessment meeting) and 2nd CHW Follow-Up Meeting (within 4 weeks of the 1st follow-up meeting)
Intervention Feasibility
Feasibility will be assessed by intervention completion rate (number of participants completing the telephone sessions with the CHW ) Consistent with other pilot intervention studies, ≥70% completion rates for intervention session.
Time frame: Baseline, Post-Discharge Week 6 Follow-up, Post-Discharge Week 12 Follow-up
PWLD quality of life
PWLD quality of life is measured by Quality of Life in Alzheimer's Disease (QoL-AD) scale (Reference: Torisson G, Stavenow L, Minthon L, Londos E. Reliability, validity and clinical correlates of the Quality of Life in Alzheimer's Disease (QoL-AD) scale in medical inpatients. Health Qual Life Outcomes. 2016;14:90.)
Time frame: Post-Discharge Week 6 Follow-up, Post-Discharge Week 12 Follow-up
PLWD 30- and 90- day hospital and ED readmissions
PLWD's 30- and 90- day hospital and ED readmission rate will be assessed by asking the caregiver to report during the interview. They will be asked: how many times the PLWD was admitted to a hospital for any reason in the last 30 days and last 90 days and how many times the PLWD was admitted to an ER for any reason in the last 30 days and last 90 days.
Time frame: Post-Discharge Week 6 Follow-up, Post-Discharge Week 12 Follow-up
Caregiver burden
Caregiver burden will be measured by the Zarit Burden Short Interview (Reference: Michel Bédard, D. William Molloy, Larry Squire, Sacha Dubois, Judith A. Lever, Martin O'Donnell, The Zarit Burden Interview: A New Short Version and Screening Version, The Gerontologist, Volume 41, Issue 5, 1 October 2001, Pages 652-657, https://doi.org/10.1093/geront/41.5.652)
Time frame: Post-discharge Week 6 Follow-up, Post-discharge Week 12 Follow-up
Caregiver well-being
Caregiver well-being will be measured by COPE scale (Reference: Aguirre, A., Benge, J.F., Finger, A., Ambiee, J., Runnels, I., Hilsabeck, R. (2024) The Caregiver Outcomes of Psychotherapy Evaluation (COPE): Development of a Social Work Assessment Tool. Clinical Social Work Journal. https://doi.org/10.1007/s10615-024-00925-2)
Time frame: Post-discharge Week 6 Follow-up and Post-discharge Week 12 Follow-up
Care transition quality
Care transition quality will be measured by the Family Caregiver Activation in Transitions (FCAT) Tool (Reference: Coleman EA, Ground KL, Maul A. The Family Caregiver Activation in Transitions (FCAT) Tool: A New Measure of Family Caregiver Self-Efficacy. Jt Comm J Qual Patient Saf. 2015;41(11):502-507.)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Post-discharge Week 6 Follow-up, Post-discharge Week 12 Follow-up
Post-discharge compliance
Post-discharge compliance will be measured by items adapted from Albrecht et al's discharge instruction comprehension measure about medications, follow-up appointments, diet, and exercise (Reference: Albrecht JS, Gruber-Baldini AL, Hirshon JM, et al. Hospital Discharge Instructions: Comprehension and Compliance Among Older Adults. J Gen Intern Med. 2014;29(11):1491-1498.)
Time frame: Post-discharge Week 6 Follow-up, Post-discharge Week 12 Follow-up