N/A N=445 Randomized Double-blind Supportive Care

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

Chronic Disease

Bottom Line

View on ClinicalTrials.gov: NCT02072941 ↗

Enrolled (actual)

445

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: New Advance Care Planning Documentation in the Medical Record at 15 Months — 83; 58 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PREPARE Intervention (Behavioral)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY New Advance Care Planning Documentation in the Medical Record at 15 Months	83; 58	—
SECONDARY Self-reported Engagement in Advance Care Planning Behaviors	3.2; 2.9; 12.4; 10.1	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02072941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.