Advance Care PlanningACP-PSHNCT06239896
Advance Care Planning With Formerly Homeless Older Adults Residing in Permanent Supportive Housing
A study testing Facilitated Group ACP Session and Facilitated one-on-one ACP visits in people with Advance Care Planning, run by University of California, San Francisco at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advance Care Planning
- What is being tested?
- Facilitated Group ACP Session and Facilitated one-on-one ACP visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 6 sitesUnited States
- Study dates
- 6 Mar 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Formerly chronically homeless adults living in permanent supportive housing
- English speaking
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Abode Services
Fremont, California, 94538
Denah Nunes
- Recruiting
Lifelong Medical Care
Oakland, California, 94612
Brenda Goldstein
- Recruiting
Mercy Housing
San Francisco, California, 94102
Jennifer Fu
- Recruiting
Delivering Innovation in Supportive Housing (DISH)
San Francisco, California, 94103
Lauren Hall
- Recruiting
Episcopal Community Services
San Francisco, California, 94103
Beth Stokes
- Recruiting
HomeRise
San Francisco, California, 94104
Kat Spiker
About this study
Official title: 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).
Read the 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.
- Conditions
- Advance Care Planning
- Being tested
- Facilitated Group ACP Session, Facilitated one-on-one ACP visits
- Keywords
- Advance Care Planning, Formerly Chronically Homeless, Older Adult, Permanent Supportive Housing, Homelessness, Aging Population, Decision Making, End of Life Care, Medical Decisions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated Group ACP SessionBehavioural
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 visitsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Facilitated one-on-one ACP visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (1)
Individual ACP Behaviors
Secondary outcomes include dichotomous versions of 5 key ACP behaviors (e.g., surrogate designation and AD completion)
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start6 Mar 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, cluster randomized trial to compare the effectiveness of delivering PREPARE-PSH via facilitated groups versus one-on-one visits
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Margot Kushel, MD, Principal investigator, University of California, San FranciscoRebecca Sudore, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239896
- Sponsor's protocol ID
- 1R01AG081326-01
- Other IDs
- 1R01AG081326-01
- Acronym
- ACP-PSH
- Status last verified
- Nov 2025
- First submitted
- 25 Jan 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31539605
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Formerly Homeless Older Adults to Engage in Advance Care Planning in Permanent Supportive Housing (ACP-PSH): An RCT
- ClinicalTrials.gov ID
- NCT06239896
- Acronym / sponsor ID
- ACP-PSH / 1R01AG081326-01
- Conditions
- Advance Care Planning
- Keywords
- Advance Care Planning, Formerly Chronically Homeless, Older Adult, Permanent Supportive Housing, Homelessness, Aging Population, Decision Making, End of Life Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, cluster randomized trial to compare the effectiveness of delivering PREPARE-PSH via facilitated groups versus one-on-one visits
| Arm | Type | Receives |
|---|---|---|
| Facilitated Group ACP Session | Active comparator | Behavioral: Facilitated Group ACP SessionParticipants 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. |
| Facilitated one-on-one ACP visits | Active comparator | Behavioral: Facilitated one-on-one ACP visitsParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Formerly chronically homeless adults living in permanent supportive housing
- English speaking
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facilitated Group ACP SessionGroup 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. | Behavioural | Facilitated Group ACP Session |
| Facilitated one-on-one ACP visitsFacilitator 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. | Behavioural | Facilitated one-on-one ACP visits |
Primary outcome
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).
1 secondary outcome
Individual ACP Behaviors
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 31539605Shi 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.
- Individual participant dataSharing planned: No
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Development and Evaluation of a Disease-oriented Scenario Game to Promote ACP Among Older Adults and Family Caregivers
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Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
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Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margot Kushel, MD principal investigator
University of California, San Francisco
Rebecca Sudore, MD principal investigator
University of California, San Francisco
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated Group ACP Session and Facilitated one-on-one ACP visits in people with Advance Care Planning, run by University of California, San Francisco at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Layan Kaileh, MSW (415-203-8350, Layan.kaileh@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACP Engagement Survey (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06239896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.