Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making
NCT ID: NCT01990235
Last Updated: 2018-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
541 participants
INTERVENTIONAL
2013-01-31
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* ≥ 2 chronic illnesses determined by International Classification of Diseases-9 (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
* 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 as determined by the SPMSQ plus an abnormal Mini-Cog
* self-reported poor vision and inability to see the words on a newspaper
* lack of a telephone
* traveling or moving out of the area for ≥3 months during the study follow- up period
55 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Rebecca Sudore, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Dean Schillinger, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Deborah E Barnes, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
W. John Boscardin, PhD
Role: PRINCIPAL_INVESTIGATOR
San Francisco Veterans Affairs Medical Center
Locations
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San Francisco General Hospital and Trauma Center
San Francisco, California, United States
Countries
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References
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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.
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.
Related Links
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Other Identifiers
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13-10847
Identifier Type: -
Identifier Source: org_study_id
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