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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.T

Abstract

BACKGROUND

Advance care planning (ACP) is a process whereby patients prepare for medical decision-making. The traditional objective of ACP has focused on the completion of advance directives. We have developed a new paradigm of ACP focused on preparing patients and their loved ones for communication and informed medical decision-making. To operationalize this new paradigm of ACP, we created an interactive, patient-centered website called PREPARE (www.prepareforyourcare.org) designed for diverse older adults.

METHODS/DESIGN

This randomized controlled trial with blinded outcome assessment is designed to determine the efficacy of PREPARE to engage older Veterans in the ACP process. Veterans who are ≥ 60 years of age, have ≥ two medical conditions, and have seen a primary care physician ≥ two times in the last year are being randomized to one of two study arms. The PREPARE study arm reviews the PREPARE website and an easy-to-read advance directive. The control arm only reviews the advance directive. The primary outcome is documentation of an advance directive and ACP discussions. Other clinically important outcomes using validated surveys include ACP behavior change process measures (knowledge, contemplation, self-efficacy, and readiness) and a full range of ACP action measures (identifying a surrogate, identifying values and goals, choosing leeway or flexibility for the surrogate, communicating with clinicians and surrogates, and documenting one's wishes). We will also assess satisfaction with decision-making and Veteran activation within primary care visits by direct audio recording. To examine the outcomes at 1 week, 3 months, and 6 months between the two study arms, we will use mixed effects linear, Poisson, or negative binomial regression and mixed effects logistic regression.

DISCUSSION

This study will determine whether PREPARE increases advance directive completion rates and engagement with the ACP process. If PREPARE is efficacious, it could prove to be an easy and effective intervention to help older adults engage in the ACP process within or outside of the medical environment. PREPARE may also help older adults communicate their medical wishes and goals to their loved ones and clinicians, improve medical decision-making, and ensure their wishes are honored over the life course.

TRIAL REGISTRATION

ClinicalTrials.gov NCT01550731 . Registered on 8 December 2011.

Authors+Show Affiliations

Division of Geriatrics, Department of Medicine, University of California, San Francisco, 3333 California St. Suite 380, San Francisco, CA, 94143, USA. rebecca.sudore@ucsf.edu. San Francisco Veterans Administration Medical Center, 4150 Clement Street, #151R, San Francisco, CA, 94121, USA. rebecca.sudore@ucsf.edu.Division of Geriatrics, Department of Medicine, University of California, San Francisco, 3333 California St. Suite 380, San Francisco, CA, 94143, USA. gem.le@ucsf.edu. Division of General Internal Medicine, San Francisco General Hospital, Center for Vulnerable Populations, University of California, San Francisco, 2789 25th Street Suite 350, San Francisco, CA, 94110, USA. gem.le@ucsf.edu.San Francisco Veterans Administration Medical Center, 4150 Clement Street, #151R, San Francisco, CA, 94121, USA. ryan.mcmahan@ucsf.edu.San Francisco Veterans Administration Medical Center, 4150 Clement Street, #151R, San Francisco, CA, 94121, USA. ryan.mcmahan@ucsf.edu.San Francisco Veterans Administration Medical Center, 4150 Clement Street, #151R, San Francisco, CA, 94121, USA. mariko.feuz@ucsf.edu.San Francisco Veterans Administration Medical Center, 4150 Clement Street, #151R, San Francisco, CA, 94121, USA. mary.katen@ucsf.edu.Division of Geriatrics, Department of Medicine, University of California, San Francisco, 3333 California St. Suite 380, San Francisco, CA, 94143, USA. deborah.barnes@ucsf.edu. Department of Psychiatry, University of California, San Francisco, CA, USA. deborah.barnes@ucsf.edu. Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA. deborah.barnes@ucsf.edu.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

26654250

Citation

Sudore, Rebecca, et al. "The Advance Care Planning PREPARE Study Among Older Veterans With Serious and Chronic Illness: Study Protocol for a Randomized Controlled Trial." Trials, vol. 16, 2015, p. 570.
Sudore R, Le GM, McMahan R, et al. The advance care planning PREPARE study among older Veterans with serious and chronic illness: study protocol for a randomized controlled trial. Trials. 2015;16:570.
Sudore, R., Le, G. M., McMahan, R., McMahon, R., Feuz, M., Katen, M., & Barnes, D. E. (2015). The advance care planning PREPARE study among older Veterans with serious and chronic illness: study protocol for a randomized controlled trial. Trials, 16, 570. https://doi.org/10.1186/s13063-015-1055-9
Sudore R, et al. 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. PubMed PMID: 26654250.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The advance care planning PREPARE study among older Veterans with serious and chronic illness: study protocol for a randomized controlled trial. AU - Sudore,Rebecca, AU - Le,Gem M, AU - McMahan,Ryan, AU - McMahon,Ryan, AU - Feuz,Mariko, AU - Katen,Mary, AU - Barnes,Deborah E, Y1 - 2015/12/12/ PY - 2015/10/06/received PY - 2015/11/12/accepted PY - 2015/12/15/entrez PY - 2015/12/15/pubmed PY - 2016/7/12/medline SP - 570 EP - 570 JF - Trials JO - Trials VL - 16 N2 - BACKGROUND: Advance care planning (ACP) is a process whereby patients prepare for medical decision-making. The traditional objective of ACP has focused on the completion of advance directives. We have developed a new paradigm of ACP focused on preparing patients and their loved ones for communication and informed medical decision-making. To operationalize this new paradigm of ACP, we created an interactive, patient-centered website called PREPARE (www.prepareforyourcare.org) designed for diverse older adults. METHODS/DESIGN: This randomized controlled trial with blinded outcome assessment is designed to determine the efficacy of PREPARE to engage older Veterans in the ACP process. Veterans who are ≥ 60 years of age, have ≥ two medical conditions, and have seen a primary care physician ≥ two times in the last year are being randomized to one of two study arms. The PREPARE study arm reviews the PREPARE website and an easy-to-read advance directive. The control arm only reviews the advance directive. The primary outcome is documentation of an advance directive and ACP discussions. Other clinically important outcomes using validated surveys include ACP behavior change process measures (knowledge, contemplation, self-efficacy, and readiness) and a full range of ACP action measures (identifying a surrogate, identifying values and goals, choosing leeway or flexibility for the surrogate, communicating with clinicians and surrogates, and documenting one's wishes). We will also assess satisfaction with decision-making and Veteran activation within primary care visits by direct audio recording. To examine the outcomes at 1 week, 3 months, and 6 months between the two study arms, we will use mixed effects linear, Poisson, or negative binomial regression and mixed effects logistic regression. DISCUSSION: This study will determine whether PREPARE increases advance directive completion rates and engagement with the ACP process. If PREPARE is efficacious, it could prove to be an easy and effective intervention to help older adults engage in the ACP process within or outside of the medical environment. PREPARE may also help older adults communicate their medical wishes and goals to their loved ones and clinicians, improve medical decision-making, and ensure their wishes are honored over the life course. TRIAL REGISTRATION: ClinicalTrials.gov NCT01550731 . Registered on 8 December 2011. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/26654250/The_advance_care_planning_PREPARE_study_among_older_Veterans_with_serious_and_chronic_illness:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-1055-9 DB - PRIME DP - Unbound Medicine ER -