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

N/ACompletedNCT02072941

University of California, San Francisco445 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

New Advance Care Planning Documentation in the Medical Record at 15 Months

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).

Time frame: 15 months after study enrollment

Secondary Outcomes

Self-reported Engagement in Advance Care Planning Behaviors

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.

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes