Preparing Older Veterans With Serious and Chronic Illness for Decision Making

NCT01550731 | Completed Results

• 1 other identifier: IIR 11-110
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

Brief Summary

Millions of diverse Veterans live with severe and chronic illness for which they will face complex, ongoing decisions. Although the VHA has been at the forefront of patient-centered chronic care, interventions to prepare Veterans for complex decision-making over the course of chronic illness are lacking. This proposal addresses this gap by testing the efficacy of a novel preparation guide designed to prepare Veterans to communicate with their surrogates and to work with clinicians to make complex, ongoing decisions. The multi-media guide teaches communication and preparation skill behaviors (e.g., how to choose a surrogate and ask clinicians questions) in a culturally appropriate, easy-to-use format (targeted to a 5th grade reading level). This study aims to provide an impetus for changing the paradigm of advance care planning policies within the VA by moving beyond documentation of end-of-life wishes to the activation of Veterans to participate in ongoing communication of their values and goals - a process that is essential to fully realize patient-centered care.

Conditions

Aging

Keywords

advance care planning; health communication; aging

Outcome Measures

Primary Outcomes (1)

• New Advance Care Planning Documentation in the Medical Record at 9 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).

  9 months after study enrollment

Secondary Outcomes (1)

• Self-reported Engagement in Advance Care Planning (ACP) Behaviors

  6 months

Study Arms (2)

PREPARE

EXPERIMENTAL

The intervention group will review the PREPARE advance care planning website and PREPARE materials plus receive an advance directive. The control group will only receive an advance directive.

Behavioral: PREPARE website

CONTROL

ACTIVE COMPARATOR

The control group will only receive an advance directive.

Behavioral: Advance directive

Interventions

PREPARE website BEHAVIORAL

Advance care planning website and materials plus an advance directive.

PREPARE

Advance directive BEHAVIORAL

The control group will only receive an advance directive.

CONTROL

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans
• years of age
• who have been seen in the General Medicine, Geriatrics, and Women's Clinics twice in the past year
• and have 2 or more serious or chronic medical conditions as determined by ICD-9 codes

You may not qualify if:

• Veterans will be excluded if they are:
• deaf
• blind
• demented

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Related Publications (8)

• McMahan RD, Knight SJ, Fried TR, Sudore RL. Advance care planning beyond advance directives: perspectives from patients and surrogates. J Pain Symptom Manage. 2013 Sep;46(3):355-65. doi: 10.1016/j.jpainsymman.2012.09.006. Epub 2012 Nov 27.

  PMID: 23200188 RESULT

• Allison TA, Sudore RL. Disregard of patients' preferences is a medical error: comment on "Failure to engage hospitalized elderly patients and their families in advance care planning". JAMA Intern Med. 2013 May 13;173(9):787. doi: 10.1001/jamainternmed.2013.203. No abstract available.

  PMID: 23545699 RESULT

• Sudore RL, Knight SJ, McMahan RD, Feuz M, Farrell D, Miao Y, Barnes DE. A novel website to prepare diverse older adults for decision making and advance care planning: a pilot study. J Pain Symptom Manage. 2014 Apr;47(4):674-86. doi: 10.1016/j.jpainsymman.2013.05.023. Epub 2013 Aug 21.

  PMID: 23972574 RESULT

• Sudore RL, Stewart AL, Knight SJ, McMahan RD, Feuz M, Miao Y, Barnes DE. Development and validation of a questionnaire to detect behavior change in multiple advance care planning behaviors. PLoS One. 2013 Sep 5;8(9):e72465. doi: 10.1371/journal.pone.0072465. eCollection 2013.

  PMID: 24039772 RESULT

• Su CT, McMahan RD, Williams BA, Sharma RK, Sudore RL. Family matters: effects of birth order, culture, and family dynamics on surrogate decision-making. J Am Geriatr Soc. 2014 Jan;62(1):175-82. doi: 10.1111/jgs.12610. Epub 2014 Jan 2.

  PMID: 24383459 RESULT

• Sudore R, Le GM, McMahan R, Feuz M, Katen M, Barnes DE. The advance care planning PREPARE study among older Veterans with serious and chronic illness: study protocol for a randomized controlled trial. Trials. 2015 Dec 12;16:570. doi: 10.1186/s13063-015-1055-9.

  PMID: 26654250 RESULT

• Sudore RL, Boscardin J, Feuz MA, McMahan RD, Katen MT, Barnes DE. Effect of the PREPARE Website vs an Easy-to-Read Advance Directive on Advance Care Planning Documentation and Engagement Among Veterans: A Randomized Clinical Trial. JAMA Intern Med. 2017 Aug 1;177(8):1102-1109. doi: 10.1001/jamainternmed.2017.1607.

  PMID: 28520838 RESULT

• Lum HD, Barnes DE, Katen MT, Shi Y, Boscardin J, Sudore RL. Improving a Full Range of Advance Care Planning Behavior Change and Action Domains: The PREPARE Randomized Trial. J Pain Symptom Manage. 2018 Oct;56(4):575-581.e7. doi: 10.1016/j.jpainsymman.2018.06.007. Epub 2018 Jun 27.

  PMID: 29940209 DERIVED

MeSH Terms

Interventions

Advance Directives

Intervention Hierarchy (Ancestors)

Jurisprudence; Social Control, Formal; Health Care Economics and Organizations; Advance Care Planning; Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

Older veterans were recruited from clinics at the SFVA, potentially limiting generalizability. Materials were viewed in study offices with computer access, potentially limiting generalizability. Study interviews and reminder calls may be activating.

Results Point of Contact

• Title: Dr. Rebecca Sudore
• Organization: Veterans Administration

Rebecca.Sudore@va.gov

(415) 221-4810

Study Officials

• Rebecca Sudore, MD

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: March 12, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 18, 2019
• Results First Posted: July 18, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)