Primary Care-based Study of an Online Workshop for Family Caregivers of PLWD

The overarching goal of this project is to improve education and support for family caregivers of persons living with dementia so that they can take better care of themselves and also their person living with dementia.

Objectives

The goals of this project are to perform a pilot embedded pragmatic clinical trial (ePCT) of the Building Better Caregivers (BBC) workshop among 108 family caregivers of persons living with dementia (PLWD) receiving care at the University of California San Francisco (UCSF) or Bassett Healthcare Network (Bassett) of New York and, in doing so, pilot test all clinical trial components necessary to the success of a future larger trial. To accomplish these goals, investigators will:

1. Evaluate the feasibility of using pragmatic methods to identify, enroll, and randomize caregivers (N=108) of PLWD who receive healthcare at UCSF or Bassett Healthcare Network to intervention (BBC workshop) or wait-list control group.
2. Determine the feasibility, acceptability, and fidelity of implementing the online 6-week workshop in USCF and Bassett primary care clinics.
3. Assess the feasibility of using pragmatic methods for clinical outcomes ascertainment including caregiver depressive symptoms (primary clinical outcome, collected through usual clinical care approaches) and ER visits and hospitalizations of PLWD (secondary outcomes)

Trial design

The study will use a randomized pilot ePCT design involving 108 family caregivers of PLWD who both receive care within the UCSF or Bassett healthcare systems. Caregivers will be randomized to BBC workshop group or wait-list control group. Outcomes assessors will be blinded to group assignment.

Outcomes

This is a pilot pragmatic randomized controlled trial designed the outcomes focus on feasibility, acceptability and fidelity end points organized by project goals as outlined below:

1. Outcomes to evaluate feasibility of pragmatic methods to identify, enroll, and randomize caregivers
2. % of invitation letters that are unopened or returned
3. % of eligible caregivers for whom contact is attempted who enroll
4. Outcomes to determine feasibility, acceptability, and fidelity of implementing workshop
5. % of caregivers assigned to workshop who complete workshop
6. % of caregivers assigned to workshop who report the workshop to be acceptable
7. % of workshop delivered with fidelity (by checklist)
8. Outcomes to assess feasibility of pragmatic methods for clinical outcomes ascertainment
9. % of enrolled caregivers who complete caregiver depressive symptoms (PHQ-8) survey questions (primary outcome)
10. emergency room visits and hospitalizations of PLWD (secondary outcomes) Study population The study population will include 108 family caregivers of PLWD. Caregivers will be patients within the UCSF or Bassett healthcare systems and will be providing support to PLWD receiving primary care at participating UCSF or Bassett clinics. PLWDs partnered with enrolled caregivers will not receive any intervention but their episodes of emergency room (ER) visits or hospitalizations will be extracted from the electronic health record (EHR). The study sites are the UCSF or Bassett healthcare systems and their respective clinics Study locations The two participating healthcare systems are UCSF and Basset and their respective outpatient clinics. Data collection and follow-up Baseline data collection occurs in the month prior to cohort launch. Follow-up data collection initiates 3 months after cohort launch and has a 4-week window. Intervention The BBC workshop is a 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia or other form of cognitive impairment. It is an evidence-based workshop of the Self-Management Resource Center originally developed at Stanford University for the Veterans Administration. The intervention is based on Self-Efficacy Theory and has a well-documented protocol that has been applied across multiple preliminary studies. Content focuses on increasing participant self-management behaviors, dementia caregiving skills, and peer social support. The workshop has been demonstrated to improve caregiver depressive symptoms, stress, self-efficacy, and well-being and reduce emergency department visits and hospitalizations of their PLWDs. The workshop uses a peer-facilitated small group format with frequent online interactions between approximately 27 participants on threaded discussion boards. Activities are guided by two trained peer co-facilitators (caregivers themselves). Participants use screen names to protect their anonymity, if desired. Each week, participants are asked to log on at least 2-3 times a week for about 10 to 30 minutes at a time. The workshop can be accessed with lower speed internet (e.g., no need for broadband) and at any time of day or night. Participation does not require "real time" attendance or video (e.g., Zoom). Instead, caregivers interact in group conversations by posting on discussion boards. Each week focuses on 2-3 new topics and tools for participants to learn and use. Participants answer questions about their caregiving challenges and their responses are posted for everyone to see. In threaded discussion board conversations participants interact, help each other, and provide peer social support. Canary Health is the digital health company that holds the license from the Self-Management Resource Center to deliver the online version of the workshop on its online platform. Randomization and blinding The study requires approximately 36 caregivers per study cohort and 3 cohorts (108 total caregiver participants). The study will use a randomization ratio of 3:1 to assign approximately 27 to workshop and 9 to wait-list control. This randomization approach enables faster accrual for each cohort. Interested wait-list control group caregivers also will be offered the workshop after their 3-month trial participation is completed. Inclusion and exclusion criteria These criteria are described elsewhere on clinicaltrials.gov. Data analysis and statistical considerations This pilot study is not powered to determine effectiveness of the workshop. Instead, we use statistical assessment and a CI-based approach to establish progression criteria for proceeding to a future large ePCT the following endpoints: feasibility of workshop completion by caregivers, workshop acceptability to caregivers, and feasibility of clinical outcome ascertainment of PHQ-8 depression symptoms score (primary clinical outcome). The Table indicates the possible scenarios we will use to decide whether a full ePCT is warranted. For each feasibility endpoint we identify possible observed outcomes and a CI approach that identifies a lower bound for the criteria (green, yellow, red) for proceeding to a future larger ePCT. Meeting the "green" criteria indicates to move forward to a future larger ePCT (based on that criterion); "yellow" indicates possibly move forward (but consider necessary modifications, e.g., intervention tailoring to particular sub-groups/settings); and " red" indicates do not move forward.
11. Feasibility of workshop completion Green: Completion rate 75%, 95% CI between (65%, 85%) with a probability of 0.942, Lower bound is 65% Yellow: Completion rate 65%, 95% CI between (54.4%, 75.6%) with a probability of 0.970, Lower bound is 54% Red: Completion rate <54%
12. Acceptability of workshop Green: Completion rate 75%, 95% CI between (65%, 85%) with a probability of 0.942, Lower bound is 65% Yellow: Completion rate 65%, 95% CI between (54.4%, 75.6%) with a probability of 0.970, Lower bound is 54% Red: Completion rate <54%
13. Feasibility of outcome ascertainment (PHQ-8) Green: Outcome ascertainment 74%, 95% CI between (65%, 83%) with a probability of 0.996, Lower bound is 65% Yellow: Outcome ascertainment 65%, 95% CI between (55.8%, 74.2%) with a probability of 0.973, Lower bound is 56% Red: Outcome ascertainment <56%