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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease
• Intervention / Treatment: Behavioral: PREPARE Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 445
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • San Francisco General Hospital and Trauma Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	15 months after study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Dean Schillinger, MD, University of California, San Francisco; Principal Investigator: Rebecca Sudore, 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

Publications and helpful links

General Publications

• Freytag J, Street RL Jr, Barnes DE, Shi Y, Volow AM, Shim JK, Alexander SC, Sudore RL. Empowering Older Adults to Discuss Advance Care Planning During Clinical Visits: The PREPARE Randomized Trial. J Am Geriatr Soc. 2020 Jun;68(6):1210-1217. doi: 10.1111/jgs.16405. Epub 2020 Mar 10.
• Sudore RL, Schillinger D, Katen MT, Shi Y, Boscardin WJ, Osua S, Barnes DE. Engaging Diverse English- and Spanish-Speaking Older Adults in Advance Care Planning: The PREPARE Randomized Clinical Trial. JAMA Intern Med. 2018 Dec 1;178(12):1616-1625. doi: 10.1001/jamainternmed.2018.4657.
• Sudore RL, Barnes DE, Le GM, Ramos R, Osua SJ, Richardson SA, Boscardin J, Schillinger D. Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial. BMJ Open. 2016 Jul 11;6(7):e011705. doi: 10.1136/bmjopen-2016-011705.

Helpful Links

• PREPARE

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimate): February 27, 2014

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Health Literacy; Aging; Advance care planning; Medical decision making; Limited English proficiency; Latino Health
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: P0061026; R-1306-01500 (Other Grant/Funding Number: Patient-Centered Outcomes Research)