NCT06239896

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Mar 2024Mar 2027

First Submitted

Initial submission to the registry

January 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 6, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

January 25, 2024

Last Update Submit

November 17, 2025

Conditions

Keywords

Advance Care PlanningFormerly Chronically HomelessOlder AdultPermanent Supportive HousingHomelessnessAging PopulationDecision MakingEnd of Life CareMedical Decisions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Individual ACP Behaviors

    Baseline, 3 months, and 6 months

Other Outcomes (2)

  • Meeting Goals of Care (exploratory)

    Baseline, 3 months, 6 months

  • Adverse Outcomes

    Baseline, 3 months, and 6 months

Study Arms (2)

Facilitated Group ACP Session

ACTIVE COMPARATOR

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

Facilitated one-on-one ACP visits

ACTIVE COMPARATOR

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

Interventions

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.

Facilitated Group ACP Session

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.

Facilitated one-on-one ACP visits

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Abode Services

Fremont, California, 94538, United States

RECRUITING

Lifelong Medical Care

Oakland, California, 94612, United States

RECRUITING

Mercy Housing

San Francisco, California, 94102, United States

RECRUITING

Delivering Innovation in Supportive Housing (DISH)

San Francisco, California, 94103, United States

RECRUITING

Episcopal Community Services

San Francisco, California, 94103, United States

RECRUITING

HomeRise

San Francisco, California, 94104, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31539605BACKGROUND

Study Officials

  • Margot Kushel, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Rebecca Sudore, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Layan Kaileh, MSW

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two-arm, cluster randomized trial to compare the effectiveness of delivering PREPARE-PSH via facilitated groups versus one-on-one visits
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 2, 2024

Study Start

March 6, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations