Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making (PREPARE)
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|ClinicalTrials.gov Identifier: NCT01990235|
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : October 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Disease||Behavioral: PREPARE Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||541 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
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.
- New advance care planning documentation in the medical record [ Time Frame: 15 months after study enrollment ]The primary outcome is documentation of ACP wishes in the medical record. ACP documentation for the purposes of this study includes legal advance directive forms or other documentation of patients wishes for medical care in clinical notes.
- Self-reported engagement in advance care planning behaviors [ Time Frame: 12 months from baseline ]Secondary outcomes were chosen to measure the full process of ACP. Using validated questionnaires, we will measure ACP behavior change processes, such as knowledge, contemplation, self-efficacy, and readiness, as well as several 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.
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): NCT01990235
|United States, California|
|San Francisco General Hospital and Trauma Center|
|San Francisco, California, United States, 94110|
|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:||W. John Boscardin, PhD||San Francisco Veterans Affairs Medical Center|