Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making (PREPARE)

• ClinicalTrials.gov Identifier: NCT01990235
• Recruitment Status: Completed
• First Posted: November 21, 2013
• Last Update Posted: October 17, 2018
• Sponsor: University of California, San Francisco
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

Brief Summary:

The objective of this proposal is to test whether a multi-media website (www.prepareforyourcare.org) that is focused on preparing older adults for communication and medical decision making can help people engage in advance care planning.

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 541 participants
• Allocation: Randomized
• 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

Arms and Interventions

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

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• English-speaking older adults (≥55 years)
• ≥ 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:

• deaf, blind, or demented 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 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

Contacts and Locations

Locations

United States, California

San Francisco General Hospital and Trauma Center

San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

National Institute on Aging (NIA)

Investigators

• 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

More Information

Additional Information:

PREPARE 

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

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.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01990235
• Other Study ID Numbers: 13-10847; R01AG045043 ( U.S. NIH Grant/Contract )
• First Posted: November 21, 2013
• Last Update Posted: October 17, 2018
• Last Verified: October 2018

Keywords provided by University of California, San Francisco:

Advance care planning; Aging; Health communication; Health literacy; Medical decision making; primary care; vulnerable population; chronic illness

Additional relevant MeSH terms:

Chronic Disease; Disease Attributes; Pathologic Processes