Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)
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 an 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making|
- Change in engagement in advance care planning behavior using validated surveys at 12 months from baseline [ Time Frame: 12 months from baseline ] [ Designated as safety issue: No ]
Engagement in 5 behaviors that is a composite outcome of ACP engagement.
- Advance Directive completion - An advance directive form, a living will, a durable power of attorney for health care, Physicians Orders of Life Sustaining Treatment, or other documentation, such as code status.
- Advance care planning discussions with surrogates - Asking someone to be a surrogate, talking about goals for medical care, whether to grant leeway, or discussions relating to medical decision making or prognosis.
- Advance care planning discussions with clinicians - Discussions concerning a surrogate, goals for medical care, whether to grant surrogates leeway, or discussions relating to medical decision making or prognosis.
- Inform others (friends/family member identified as important) - Discussions about advance care planning-related topics
- Ask doctors questions - risks, benefits, options.
These behaviors will be measured using validated surveys on a 1 to 5 scale.
- Change in advance care planning behavior at 12 months from baseline [ Time Frame: 12 months from baseline ] [ Designated as safety issue: No ]
- Advance care planning behavior change
- Self-efficacy with advance care planning behaviors
- Engagement in medical decision making
- Satisfaction with medical decision making
- Surrogate-reports of patient engagement in advance care planning
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02072941
|Contact: Rebecca Sudore, MD||415-221-4810 ext email@example.com|
|Contact: Ryan McMahan, BS||415-221-4810 ext firstname.lastname@example.org|
|United States, California|
|San Francisco General Hospital and Trauma Center||Recruiting|
|San Francisco, California, United States, 94110|
|Contact: Rebecca Sudore, MD 415-221-4810 ext 3475 email@example.com|
|Contact: Ryan McMahan, BS 415-221-4810 ext 3311 firstname.lastname@example.org|
|Principal Investigator: Rebecca Sudore, MD|
|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|