Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)
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|ClinicalTrials.gov Identifier: NCT02072941|
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : July 11, 2019
Last Update Posted : July 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Disease||Behavioral: PREPARE Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||445 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Experimental: 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.
Behavioral: PREPARE Intervention
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.
No Intervention: 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.
- New Advance Care Planning Documentation in the Medical Record at 15 Months [ Time Frame: 15 months after study enrollment ]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).
- Self-reported Engagement in Advance Care Planning Behaviors [ Time Frame: 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072941
|United States, California|
|San Francisco General Hospital and Trauma Center|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Rebecca Sudore, MD||University of California, San Francisco|
|Principal Investigator:||Dean Schillinger, MD||University of California, San Francisco|
|Principal Investigator:||Deborah E Barnes, PhD||University of California, San Francisco|
|Principal Investigator:||John Boscardin, PhD||University of California, San Francisco|
|Principal Investigator:||Janet Shim, PhD||University of California, San Francisco|