Local research. Human connections. WCR Miami Lakes (786) 483-7856
Back to study searchNCT06239896
RecruitingNCT06239896ClinicalTrials.gov record

Advance Care Planning With Formerly Homeless Older Adults Residing in Permanent Supportive Housing

Advance Care Planning

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Interventional
Phase
Not applicable
Age range
50 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Accepted
Participants
650 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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).

Read the full 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, we will be sending out a survey via REDCap to PSH staff (N=60) to complete on their own time when we have finished our study activities in the building (6 months from baseline). Relevance to NIH and public health: PREPARE-PSH may reduce health disparities in ACP among formerly chronically homeless older adults.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
No masking
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

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

Facilitated Group ACP Session BEHAVIORAL

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 one-on-one ACP visits BEHAVIORAL

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

ACP Engagement Survey

Time frame: Baseline, 3 months, and 6 months

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).

Secondary measures

Individual ACP Behaviors

Time frame: Baseline, 3 months, and 6 months

Secondary outcomes include dichotomous versions of 6 key ACP behaviors (1. Surrogate Designation 2. Discuss surrogate with clinicians 3. Surrogate documentation 4. Discuss ACP wishes with surrogates 5. Discuss ACP wishes with clinicians 6. ACP documentation )

Other measures

Adverse Outcomes

Time frame: Baseline, 3 months, and 6 months

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (6)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

6 locations

Abode ServicesFremont, California, United StatesRecruiting
Denah NunesCONTACT
View location on map ↗
Lifelong Medical CareOakland, California, United StatesRecruiting
Brenda GoldsteinCONTACT
View location on map ↗
Mercy HousingSan Francisco, California, United StatesRecruiting
Jennifer FuCONTACT
View location on map ↗
Delivering Innovation in Supportive Housing (DISH)San Francisco, California, United StatesRecruiting
Lauren HallCONTACT
View location on map ↗
Episcopal Community ServicesSan Francisco, California, United StatesRecruiting
Beth StokesCONTACT
View location on map ↗
HomeRiseSan Francisco, California, United StatesRecruiting
Kat SpikerCONTACT
View location on map ↗

Study team and timeline

Lead sponsor
University of California, San Francisco
Study start
Mar 6, 2024 Actual
Primary completion
2027-03 Estimated
Study completion
2027-03 Estimated
First posted
Feb 2, 2024 Actual
Last updated
Nov 9, 2026 Actual

Official study contacts

Layan Kaileh, MSWCONTACTLayan.kaileh@ucsf.edu415-203-8350
Official study title

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

A HUMAN NEXT STEP

Ask Wellness Clinical Research

Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.

Please do not include medical records, diagnoses, medications, insurance numbers or other sensitive details. This form is for general questions, not urgent care.

Sending a question does not enroll you in a trial.

Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026