Pianificazione anticipata dell'assistenza agli anziani precedentemente senza dimora che risiedono in alloggi di sostegno permanenti (ACP-PSH)
Consentire agli anziani, precedentemente senza dimora, di impegnarsi nella pianificazione anticipata dell'assistenza in alloggi di supporto permanenti (ACP-PSH): un studio randomizzato
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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Layan Kaileh, MSW
- Numero di telefono: 415-203-8350
- Email: Layan.kaileh@ucsf.edu
Luoghi di studio
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California
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Fremont, California, Stati Uniti, 94538
- Reclutamento
- Abode Services
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Contatto:
- Denah Nunes
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Oakland, California, Stati Uniti, 94612
- Reclutamento
- Lifelong Medical Care
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Contatto:
- Brenda Goldstein
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San Francisco, California, Stati Uniti, 94102
- Reclutamento
- Mercy Housing
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Contatto:
- Jennifer Fu
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San Francisco, California, Stati Uniti, 94103
- Reclutamento
- Delivering Innovation in Supportive Housing (DISH)
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Contatto:
- Lauren Hall
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San Francisco, California, Stati Uniti, 94103
- Reclutamento
- Episcopal Community Services
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Contatto:
- Beth Stokes
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San Francisco, California, Stati Uniti, 94104
- Reclutamento
- HomeRise
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Contatto:
- Kat Spiker
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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. |
|
Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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ACP Engagement Survey
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Individual ACP Behaviors
Lasso di tempo: Baseline, 3 months, and 6 months
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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
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Adverse Outcomes
Lasso di tempo: Baseline, 3 months, and 6 months
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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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Rebecca Sudore, MD, University of California, San Francisco
- Investigatore principale: Margot Kushel, MD, University of California, San Francisco
Pubblicazioni e link utili
Collegamenti utili
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 1R01AG081326-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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