Clinical trial NCT02072941: Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)
Official title: Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Advance care planning
Latino Health
Medical decision making
Health Literacy
Limited English proficiency
Aging
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-02-27
Enrollment: 445
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: New Advance Care Planning Documentation in the Medical Record at 15 Months
timeFrame: 15 months after study enrollment
Secondary outcomes:
measure: Self-reported Engagement in Advance Care Planning Behaviors
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital and Trauma Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Rebecca Sudore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Dean Schillinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Deborah E Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: John Boscardin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Janet Shim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.