永続的支援住宅に住む元ホームレスの高齢者を対象とした事前ケア計画 (ACP-PSH)
元ホームレスの高齢者が永続的支援住宅での事前ケア計画に参加できるようにする (ACP-PSH): 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).
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Layan Kaileh, MSW
- 電話番号：415-203-8350
- メール：Layan.kaileh@ucsf.edu
研究場所
-
-
California
-
Fremont、California、アメリカ、94538
- 募集
- Abode Services
-
コンタクト：
- Denah Nunes
-
Oakland、California、アメリカ、94612
- 募集
- Lifelong Medical Care
-
コンタクト：
- Brenda Goldstein
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San Francisco、California、アメリカ、94102
- 募集
- Mercy Housing
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コンタクト：
- Jennifer Fu
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San Francisco、California、アメリカ、94103
- 募集
- Delivering Innovation in Supportive Housing (DISH)
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コンタクト：
- Lauren Hall
-
San Francisco、California、アメリカ、94103
- 募集
- Episcopal Community Services
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コンタクト：
- Beth Stokes
-
San Francisco、California、アメリカ、94104
- 募集
- HomeRise
-
コンタクト：
- Kat Spiker
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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. |
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ACP Engagement Survey
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Individual ACP Behaviors
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adverse Outcomes
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Rebecca Sudore, MD、University of California, San Francisco
- 主任研究者：Margot Kushel, MD、University of California, San Francisco
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1R01AG081326-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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