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

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Disease

Intervention: PREPARE Intervention (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Rebecca Sudore, MD, Principal Investigator, Affiliation: University of California, San Francisco
Dean Schillinger, MD, Principal Investigator, Affiliation: University of California, San Francisco
Deborah E Barnes, PhD, Principal Investigator, Affiliation: University of California, San Francisco
John Boscardin, PhD, Principal Investigator, Affiliation: University of California, San Francisco
Janet Shim, PhD, Principal Investigator, Affiliation: University of California, San Francisco

Overall contact:
Rebecca Sudore, MD, Phone: 415-221-4810, Ext: 3475, Email: rebecca.sudore@ucsf.edu

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 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.

Clinical Details

Official title: Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome: Change in engagement in advance care planning behavior using validated surveys at 12 months from baseline

Secondary outcome: Change in advance care planning behavior at 12 months from baseline

Detailed description: 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.

Eligibility

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Rebecca Sudore, MD, Phone: 415-221-4810, Ext: 3475, Email: rebecca.sudore@ucsf.edu

San Francisco General Hospital and Trauma Center, San Francisco, California 94110, United States; Recruiting
Rebecca Sudore, MD, Phone: 415-221-4810, Ext: 3475, Email: rebecca.sudore@ucsf.edu
Ryan McMahan, BS, Phone: 415-221-4810, Ext: 3311, Email: ryan.mcmahan@ucsf.edu
Rebecca Sudore, MD, Principal Investigator
Additional Information

PREPARE

Starting date: September 2014
Last updated: May 29, 2015

Page last updated: August 23, 2015

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