Vroegtijdige zorgplanning voor voorheen dakloze ouderen die in permanente ondersteunende huisvesting verblijven (ACP-PSH)
Voormalig dakloze ouderen in staat stellen deel te nemen aan vroegtijdige zorgplanning in permanente ondersteunende huisvesting (ACP-PSH): een 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).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Layan Kaileh, MSW
- Telefoonnummer: 415-203-8350
- E-mail: Layan.kaileh@ucsf.edu
Studie Locaties
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California
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Fremont, California, Verenigde Staten, 94538
- Werving
- Abode Services
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Contact:
- Denah Nunes
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Oakland, California, Verenigde Staten, 94612
- Werving
- Lifelong Medical Care
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Contact:
- Brenda Goldstein
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San Francisco, California, Verenigde Staten, 94102
- Werving
- Mercy Housing
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Contact:
- Jennifer Fu
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San Francisco, California, Verenigde Staten, 94103
- Werving
- Delivering Innovation in Supportive Housing (DISH)
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Contact:
- Lauren Hall
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San Francisco, California, Verenigde Staten, 94103
- Werving
- Episcopal Community Services
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Contact:
- Beth Stokes
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San Francisco, California, Verenigde Staten, 94104
- Werving
- HomeRise
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Contact:
- Kat Spiker
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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. |
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. |
|
Actieve vergelijker: 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. |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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ACP Engagement Survey
Tijdsspanne: Baseline, 3 months, and 6 months
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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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Individual ACP Behaviors
Tijdsspanne: 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 ) |
Baseline, 3 months, and 6 months
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Adverse Outcomes
Tijdsspanne: 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. |
Baseline, 3 months, and 6 months
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Rebecca Sudore, MD, University of California, San Francisco
- Hoofdonderzoeker: Margot Kushel, MD, University of California, San Francisco
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 1R01AG081326-01 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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