Clinical trial NCT06239896: Advance Care Planning With Formerly Homeless Older Adults Residing in Permanent Supportive Housing
Official title: Empowering Formerly Homeless Older Adults to Engage in Advance Care Planning in Permanent Supportive Housing (ACP-PSH): An RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advance Care Planning
Keywords: Advance Care Planning
Formerly Chronically Homeless
Older Adult
Permanent Supportive Housing
Homelessness
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-02-02
Enrollment: 650
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, cluster randomized trial to compare the effectiveness of delivering PREPARE-PSH via facilitated groups versus one-on-one visits
Primary purpose: SUPPORTIVE_CARE

Brief summary: The homeless population is aging, with an increasing proportion of individuals over age 50 who experience accelerated aging, high rates of mortality, and a high risk of not having their wishes honored at the end of life. The goal of this randomized control trial (RCT) is to test the effectiveness of adapted evidence-based advance care planning (ACP) interventions for formerly chronically homeless older adults living in permanent supportive housing (PSH).

Detailed description: Advance care planning (ACP) aims to elicit patients' medical preferences; yet older adults experiencing chronic homeless have low rates of ACP. Significant policy attention has focused on rehousing chronically homeless people into Permanent Supportive Housing (PSH), subsidized permanent housing with voluntary supportive services. Our team will use PREPARE for Your Care (PREPARE) - an easy-to-use, evidence-based, online ACP program with video stories. This program includes easy-to-read advance directives, an ACP group visit guide, and an ACP one-on-one facilitation guide. Our team developed a Community Advisory Board (CAB) and together identified preliminary adaptations to the PREPARE materials for the PSH setting.

The objective of this proposal is to co-develop PREPARE-PSH and compare the effectiveness of facilitated group versus one-on-one visits among formerly chronically homeless older adults in PSH. In Aim 1 the investigators will engage in a rigorous co-development process through in-depth interviews and focus groups with 20 PSH residents and the CAB. The investigators will use a theory-informed framework and qualitative content analysis to co-create a PREPARE-PSH program. For Aim 2, the investigators will conduct a Hybrid (NIH Stage III efficacy/effectiveness), Type 1 cluster randomized trial to compare the delivery of PREPARE-PSH through facilitated groups vs. one-on-one visits using mixed effects models. Randomization will be at the site level, balanced by site size. In Aim 3, the investigators will purposively sample Aim 2 participants for in-depth interviews (n=30-40), conduct focus groups with PSH staff (n=30-40), and obtain input from CAB members (total n=10-15). The investigators will explore implementation-relevant factors associated with: (a) high and low ACP engagement and sustainability of PREPARE-PSH using the Behavior Change Wheel (BCW and the Consolidated Framework for Implementation Research (CFIR) model. Relevance to NIH and public health: PREPARE-PSH may reduce health disparities in ACP among formerly chronically homeless older adults.

Eligibility criteria: Inclusion Criteria:

* Formerly chronically homeless adults living in permanent supportive housing
* English speaking

Exclusion Criteria:

* Non-English Speaking
* Screen positive for moderate-to-severe cognitive impairment
* Self-report being deaf or blind
* Cannot provide informed consent based on the teach back method

Primary outcomes:
measure: ACP Engagement Survey
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
measure: Individual ACP Behaviors
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
measure: Meeting Goals of Care (exploratory)
timeFrame: Baseline, 3 months, 6 months
measure: Adverse Outcomes
timeFrame: Baseline, 3 months, and 6 months
Locations:
city: Fremont
country: United States
facility: Abode Services
state: California
city: Oakland
country: United States
facility: Lifelong Medical Care
state: California
city: San Francisco
country: United States
facility: Mercy Housing
state: California
city: San Francisco
country: United States
facility: Delivering Innovation in Supportive Housing (DISH)
state: California
city: San Francisco
country: United States
facility: Episcopal Community Services
state: California
city: San Francisco
country: United States
facility: HomeRise
state: California
Study officials:
affiliation: University of California, San Francisco
name: Margot Kushel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Rebecca Sudore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi Y, Barnes DE, Boscardin J, You JJ, Heyland DK, Volow AM, Howard M, Sudore RL. Brief English and Spanish Survey Detects Change in Response to Advance Care Planning Interventions. J Pain Symptom Manage. 2019 Dec;58(6):1068-1074.e5. doi: 10.1016/j.jpainsymman.2019.09.004. Epub 2019 Sep 18.