Forudgående plejeplanlægning med tidligere hjemløse ældre voksne, der bor i permanent støttende bolig (ACP-PSH)
Bemyndigelse af tidligere hjemløse ældre voksne til at engagere sig i forudgående plejeplanlægning i permanent støttende bolig (ACP-PSH): En 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).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Layan Kaileh, MSW
- Telefonnummer: 415-203-8350
- E-mail: Layan.kaileh@ucsf.edu
Studiesteder
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California
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Fremont, California, Forenede Stater, 94538
- Rekruttering
- Abode Services
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Kontakt:
- Denah Nunes
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Oakland, California, Forenede Stater, 94612
- Rekruttering
- Lifelong Medical Care
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Kontakt:
- Brenda Goldstein
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San Francisco, California, Forenede Stater, 94102
- Rekruttering
- Mercy Housing
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Kontakt:
- Jennifer Fu
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San Francisco, California, Forenede Stater, 94103
- Rekruttering
- Delivering Innovation in Supportive Housing (DISH)
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Kontakt:
- Lauren Hall
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San Francisco, California, Forenede Stater, 94103
- Rekruttering
- Episcopal Community Services
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Kontakt:
- Beth Stokes
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San Francisco, California, Forenede Stater, 94104
- Rekruttering
- HomeRise
-
Kontakt:
- Kat Spiker
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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. |
|
Aktiv komparator: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
ACP Engagement Survey
Tidsramme: 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). |
Baseline, 3 months, and 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Individual ACP Behaviors
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse Outcomes
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Rebecca Sudore, MD, University of California, San Francisco
- Ledende efterforsker: Margot Kushel, MD, University of California, San Francisco
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 1R01AG081326-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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