Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making

NCT01990235 | Completed DMC

• 2 other identifiers: 13-10847R01AG045043
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• New advance care planning documentation in the medical record

  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.

  15 months after study enrollment

Secondary Outcomes (1)

• Self-reported engagement in advance care planning behaviors

  12 months from baseline

Study Arms (2)

PREPARE intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

PREPARE Intervention BEHAVIORAL

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.

PREPARE intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

Location

Related Publications (4)

• 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.

  PMID: 37335910 DERIVED

• 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.

  PMID: 32157684 DERIVED

• 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.

  PMID: 30383086 DERIVED

• 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.

  PMID: 27401363 DERIVED

Related Links

• PREPARE

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 21, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

US (1)