Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)
2019年4月22日 更新者：University of California, San Francisco
Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making
In partnership with patients, caregivers, advocacy groups and clinicians, the investigators plan to:
Aim 1: Adapt and refine PREPARE in Spanish through cognitive interviews with Spanish-speaking Latinos and stakeholders.
Aim 2: Conduct a randomized clinical trial (RCT) to compare the efficacy of PREPARE plus a previously-tested, easy-to-read- AD (intervention) versus the AD alone (control) to:
2a. Engage older Spanish-speaking Latinos in multiple ACP behaviors (i.e., identify and discuss wishes with surrogates and clinicians and complete ADs) measured by self-report, chart review, surrogate reports, and
2b. Direct observation.
2c. Improve self-efficacy and satisfaction with medical decision making.
2d. Determine whether PREPARE efficacy varies by literacy, decision control preferences, and clinician-patient language concordance.
Aim 3: Disseminate PREPARE with input from patients, surrogates, and stakeholders.
調査の概要
詳細な説明
PREPARE is a website (www.prepareforyourcare.org) that teaches patients how to identify what is most important in life, how to communicate their preferences to clinicians and loved ones, and how to make informed decisions.
It is written at a 5th grade level and includes voice-overs of text and closed captioning of videos that model advance care planning behaviors.
The goal of this proposal is to test the efficacy of PREPARE plus an easy-to-read advance directive, versus an advance directive alone, to improve patient engagement in multiple advance care planning behaviors including discussions with surrogate decision makers and clinicians in addition to advance directive completion.
The investigators will also determine whether PREPARE can empower and activate patients within clinical encounters with their clinicians and help to decrease health disparities in advance care planning.
研究の種類
介入
入学 (実際)
445
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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San Francisco、California、アメリカ、94110
- San Francisco General Hospital and Trauma Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
55年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Spanish-speaking adults ≥ 55 years of age
- ≥ 2 chronic illnesses determined by ICD-9 codes
- ≥ 2 visits with an outpatient primary care clinician at San Francisco General hospital in the past year
- ≥ 2 additional outpatient/inpatient visits to San Francisco General Hospital in the past year
Exclusion Criteria:
- Deaf, blind, demented or psychotic as determined by ICD-9 codes
- Too mentally or physically ill to participate as determined by their clinicians
- Moderate or severe cognitive impairment as determined by the Short Portable Mental Status Questionnaire (SPMSQ), and mild cognitive impairment by the SPMSQ plus an abnormal Mini-Cog (scores minimally affected by education/ethnicity)
- Self-reported poor vision and inability to see the words on a newspaper
- Lack of a telephone (for follow-up)
- Traveling or moving out of the area for ≥3 months during the study follow-up period.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：PREPARE intervention
The PREPARE arm will review the PREPARE website plus the easy-to-read advance directive (AD).
Participants will review PREPARE on their own for ≥20 minutes with staff present to answer questions.
During PREPARE, participants answer preference questions and make an action plan (i.e., commitment to engage in advance care planning).
To ensure home access to PREPARE content, participants will be given a website login and PREPARE content in digital video disc (DVD), booklet, and pamphlet format as well as the action plan and AD.
One to three days before a primary care visit, the PREPARE arm will receive a reminder to come to their appointment and to bring their action plan.
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At week 1, 3, 6, and 12 months, interviews (telephone or in person based on preference) by blinded staff will assess engagement in advance care planning (ACP), self-efficacy with ACP, and activation in and satisfaction with decision making.
Blinded telephone interviews will also assess surrogate reports of patient engagement in ACP.
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介入なし：Control
The control arm will review an easy-to-read AD.
Controls will review the AD for ≥15 minutes with study staff present to answer questions and will take the AD home to complete if desired.
One to three days before a primary care visit, controls will receive a reminder to come to their appointment.
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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 |
|---|---|---|
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New Advance Care Planning Documentation in the Medical Record at 15 Months
時間枠：15 months after study enrollment
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The primary outcome is documentation of advance care planning wishes in the medical record.
ACP documentation for the purposes of this study includes the easy-to-read advance directive or other valid advance directives or living wills, a durable power of attorney for healthcare document (DPOAHC), a physicians orders for life sustaining treatment (POLST) form, or other documentation of patients wishes for medical care (ie, documentation of oral directives by a physician, or code status, such as full code or do not resuscitate or do not intubate orders or notes by a physician).
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15 months after study enrollment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Self-reported Engagement in Advance Care Planning Behaviors
時間枠：12 months
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Secondary outcomes were chosen to measure the full process of Advance Care Planning (ACP) using validated questionnaires, such as the patient-reported ACP Engagement Survey.
This questionnaire includes both Behavior Change Process and ACP Action measures.
Behavior Change Process measures include knowledge, contemplation, self-efficacy, and readiness for several ACP actions.
The Process measures are assessed on an average 5-point Likert scale with a low of 1 and a high of 5, with high scores indicating more ACP engagement.
Action measures include ACP actions such as identifying a surrogate decision-maker, identifying values and goals for medical care, choosing the level of leeway in surrogate decision-making, discussing one's wishes with clinicians and surrogates, and documenting one's wishes in an advance directive.
Action measures use "yes" or "no" response options and are measured on a 0- to 25-point scale, where 0 is no action and 25 means they have engaged in more ACP actions.
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12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Dean Schillinger, MD、University of California, San Francisco
- 主任研究者：Rebecca Sudore, MD、University of California, San Francisco
- 主任研究者：Deborah E Barnes, PhD、University of California, San Francisco
- 主任研究者：John Boscardin, PhD、University of California, San Francisco
- 主任研究者：Janet Shim, PhD、University of California, San Francisco
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Freytag J, Street RL Jr, Barnes DE, Shi Y, Volow AM, Shim JK, Alexander SC, Sudore RL. Empowering Older Adults to Discuss Advance Care Planning During Clinical Visits: The PREPARE Randomized Trial. J Am Geriatr Soc. 2020 Jun;68(6):1210-1217. doi: 10.1111/jgs.16405. Epub 2020 Mar 10.
- Sudore RL, Schillinger D, Katen MT, Shi Y, Boscardin WJ, Osua S, Barnes DE. Engaging Diverse English- and Spanish-Speaking Older Adults in Advance Care Planning: The PREPARE Randomized Clinical Trial. JAMA Intern Med. 2018 Dec 1;178(12):1616-1625. doi: 10.1001/jamainternmed.2018.4657.
- Sudore RL, Barnes DE, Le GM, Ramos R, Osua SJ, Richardson SA, Boscardin J, Schillinger D. Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial. BMJ Open. 2016 Jul 11;6(7):e011705. doi: 10.1136/bmjopen-2016-011705.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年9月1日
一次修了 (実際)
2017年3月1日
研究の完了 (実際)
2017年3月1日
試験登録日
最初に提出
2014年2月24日
QC基準を満たした最初の提出物
2014年2月26日
最初の投稿 (見積もり)
2014年2月27日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月11日
QC基準を満たした最後の更新が送信されました
2019年4月22日
最終確認日
2019年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。