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

NCT02072941 | Completed Results DMC

• 2 other identifiers: P0061026R-1306-01500
• Study Type: interventional
• Target: 445
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Disease

Keywords

Advance care planning; Latino Health; Medical decision making; Health Literacy; Limited English proficiency; Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Self-reported Engagement in Advance Care Planning Behaviors

  12 months

Study Arms (2)

PREPARE intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

PREPARE Intervention BEHAVIORAL

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.

PREPARE intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

Location

Related Publications (4)

• Gelfman LP, Barnes DE, Goldstein N, Volow AM, Shi Y, Li B, Sudore RL. Quality and Satisfaction With Advance Care Planning Conversations Among English- and Spanish-Speaking Older Adults. J Palliat Med. 2023 Oct;26(10):1380-1385. doi: 10.1089/jpm.2022.0565. Epub 2023 Jun 19.

  PMID: 37335910 DERIVED

• 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.

  PMID: 32157684 DERIVED

• 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.

  PMID: 30383086 DERIVED

• 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.

  PMID: 27401363 DERIVED

Related Links

• PREPARE

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Participants could not be blinded. In addition, this study took place in one area of the country among Spanish-speaking, older patients who obtain care from safety-net settings. This may affect the generalizability of our findings.

Results Point of Contact

• Title: Dr. Rebecca Sudore
• Organization: University of California San Francisco

rebecca.sudore@ucsf.edu

(415) 221-4810

Study Officials

• Rebecca Sudore, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Dean Schillinger, 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: February 27, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 11, 2019
• Results First Posted: July 11, 2019

Record last verified: 2019-04

Locations

US (1)