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Recruiting NCT06239896

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

No phase Interventional Advance Care Planning

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Facilitated Group ACP Session, Facilitated one-on-one ACP visits.
Who it may be relevant to
Registry conditions: Advance Care Planning. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 t
  • 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 the

Primary outcome measures

  • ACP Engagement Survey [Time frame: Baseline, 3 months, and 6 months]
Secondary outcome measures (1)
  • Individual ACP Behaviors [Time frame: Baseline, 3 months, and 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 6 centers
  • Abode Services — Fremont
  • Lifelong Medical Care — Oakland
  • Mercy Housing — San Francisco
  • Delivering Innovation in Supportive Housing (DISH) — San Francisco
  • Episcopal Community Services — San Francisco
  • HomeRise — San Francisco

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. PMID 31539605

Identifiers

NCT: NCT06239896 · 1R01AG081326-01 · 1R01AG081326-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗