Advance Care Planning With Formerly Homeless Older Adults Residing in Permanent Supportive Housing (ACP-PSH)

Empowering Formerly Homeless Older Adults to Engage in Advance Care Planning in Permanent Supportive Housing (ACP-PSH): An RCT

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).

Study Overview

• Status: Recruiting
• Conditions: Advance Care Planning
• Intervention / Treatment: Behavioral: Facilitated Group ACP Session; Behavioral: Facilitated one-on-one ACP visits

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.

• Study Type: Interventional
• Enrollment (Estimated): 650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Layan Kaileh, MSW; Phone Number: 415-203-8350; Email: Layan.kaileh@ucsf.edu

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Recruiting
      • Abode Services
      • Contact: Denah Nunes
    • Oakland, California, United States, 94612
      • Recruiting
      • Lifelong Medical Care
      • Contact: Brenda Goldstein
    • San Francisco, California, United States, 94102
      • Recruiting
      • Mercy Housing
      • Contact: Jennifer Fu
    • San Francisco, California, United States, 94103
      • Recruiting
      • Delivering Innovation in Supportive Housing (DISH)
      • Contact: Lauren Hall
    • San Francisco, California, United States, 94103
      • Recruiting
      • Episcopal Community Services
      • Contact: Beth Stokes
    • San Francisco, California, United States, 94104
      • Recruiting
      • HomeRise
      • Contact: Kat Spiker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Facilitated Group ACP Session; Participants in the group ACP visit arm will attend a one-time 90-minute facilitated group ACP session where they will review the movie version of the PREPARE program (about how to choose a medical decision maker and how to decide what matters most in life), including a new PSH-specific video and PREPARE easy-to-read ADs with the new PSH-specific content and cover letters.	Behavioral: Facilitated Group ACP Session; Group Facilitators will adhere to the standardized scripts and protocols to engage participants in ACP through group sessions. Participants will view the movie version of the PREPARE program (about how to choose a medical decision maker and how to decide what matters most in life), including a new PSH-specific video. Participants are provided with a workbook to follow along with the movies. They are also provide the PREPARE easy-to-read advance directive legal forms that they can fill out when they are ready. These forms include new PSH-specific content and a PSH-specific cover letter.
Active Comparator: Facilitated one-on-one ACP visits; Participants in the one-on-one ACP visit arm will attend a one-time 90-minute ACP session with a facilitator where they will review the movie version of the PREPARE program (about how to choose a medical decision maker and how to decide what matters most in life), including a new PSH-specific video and PREPARE easy-to-read ADs with the new PSH-specific content and cover letters.	Behavioral: Facilitated one-on-one ACP visits; Facilitator adheres to the scripts and protocols to engage participants in advance care planning through one-on-one ACP sessions. Participants will view the movie version of the PREPARE program (about how to choose a medical decision maker and how to decide what matters most in life), including a new PSH-specific video. Participants are provided with a workbook that they can use to follow along with the movies. They are also provide the PREPARE easy-to-read advance directive legal forms that they can fill out when they are ready. These forms include new PSH-specific content and a PSH-specific cover letter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACP Engagement Survey	Our primary analyses will compare change in engagement using the 9-item ACP Engagement Survey average 5-point Likert scores from baseline to 3 and 6 months between study arms (groups vs. one-on-one sessions).	Baseline, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual ACP Behaviors	Secondary outcomes include dichotomous versions of 5 key ACP behaviors (e.g., surrogate designation and AD completion)	Baseline, 3 months, and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meeting Goals of Care (exploratory)	The field of ACP is evolving, including its recommendations on appropriate and feasible ACP measures. There are no validated self reported or chart abstraction measures for goal concordant care, and there is debate about whether this outcome can be measured effectively. One recommendation is to measure whether the interventions met individuals' needs. Our team will assess if the materials and interventions met a participant's needs for ACP information.	Baseline, 3 months, 6 months
Adverse Outcomes	In several prior randomized trials of the PREPARE program in other marginalized populations, our team have not detected any adverse outcomes. However, to monitor for trends, our team will screen for the presence of anxiety and depression using the PHQ-4 and will collect open-ended reports of any PSH residents who report feeling uncomfortable.	Baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Rebecca Sudore, MD, University of California, San Francisco; Principal Investigator: Margot Kushel, MD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Decision Making; Homelessness; Advance Care Planning; End of Life Care; Older Adult; Medical Decisions; Aging Population; Formerly Chronically Homeless; Permanent Supportive Housing
• Other Study ID Numbers: 1R01AG081326-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No