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

Advance Care Planning Clinical Trial

— ACP-PSH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239896
• Other study ID #: 1R01AG081326-01
• Secondary ID: 1R01AG081326-01
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2024
• Est. completion date: March 2027

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Layan Kaileh, MSW
• Phone: 415-203-8350
• Email: Layan.kaileh[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advance Care Planning

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Lifelong Medical Care	Oakland	California
United States	Delivering Innovation in Supportive Housing (DISH)	San Francisco	California
United States	Episcopal Community Services	San Francisco	California
United States	HomeRise	San Francisco	California
United States	Mercy Housing	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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