Back to resultsPreparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)
Primary Purpose
Chronic Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PREPARE Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Disease focused on measuring Advance care planning, Latino Health, Medical decision making, Health Literacy, Limited English proficiency, Aging
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.
Sites / Locations
- San Francisco General Hospital and Trauma Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PREPARE intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02072941
First Posted
February 24, 2014
Last Updated
April 22, 2019
Sponsor
University of California, San Francisco
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02072941
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Advance care planning, Latino Health, Medical decision making, Health Literacy, Limited English proficiency, Aging
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
445 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PREPARE intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PREPARE Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
New Advance Care Planning Documentation in the Medical Record at 15 Months
Description
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 Outcome Measure Information:
Title
Self-reported Engagement in Advance Care Planning Behaviors
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Sudore, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dean Schillinger, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborah E Barnes, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Boscardin, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janet Shim, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital and Trauma Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32157684
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.
Results Reference
derived
PubMed Identifier
30383086
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.
Results Reference
derived
PubMed Identifier
27401363
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.
Results Reference
derived
Links:
URL
http://www.prepareforyourcare.org
Description
PREPARE
Learn more about this trial
Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)
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