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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02072941
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Disease Behavioral: PREPARE Intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 445 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making
Study Start Date : September 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. New Advance Care Planning Documentation in the Medical Record at 15 Months [ Time Frame: 15 months after study enrollment ]
    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).


Secondary Outcome Measures :
  1. Self-reported Engagement in Advance Care Planning Behaviors [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072941


Locations
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United States, California
San Francisco General Hospital and Trauma Center
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Study Protocol and Statistical Analysis Plan  [PDF] September 1, 2017

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02072941    
Other Study ID Numbers: P0061026
R-1306-01500 ( Other Grant/Funding Number: Patient-Centered Outcomes Research )
First Posted: February 27, 2014    Key Record Dates
Results First Posted: July 11, 2019
Last Update Posted: July 11, 2019
Last Verified: April 2019
Keywords provided by University of California, San Francisco:
Advance care planning
Latino Health
Medical decision making
 Health Literacy
Limited English proficiency
Aging
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes