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Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)

NCT02072941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 445

Last updated 2019-07-11

Study results available
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Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Rebecca Sudore, MD · University of California, San Francisco

  • Dean Schillinger, MD · University of California, San Francisco

  • Deborah E Barnes, PhD · University of California, San Francisco

  • John Boscardin, PhD · University of California, San Francisco

  • Janet Shim, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02072941 on ClinicalTrials.gov