Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial

Rebecca L Sudore; Deborah E Barnes; Gem M Le; Roberto Ramos; Stacy J Osua; Sarah A Richardson; John Boscardin; Dean Schillinger

doi:10.1136/bmjopen-2016-011705

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.

Authors

Rebecca L Sudore¹, Deborah E Barnes², Gem M Le³, Roberto Ramos⁴, Stacy J Osua⁴, Sarah A Richardson⁴, John Boscardin⁵, Dean Schillinger⁶

Affiliations

¹ Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, California, USA San Francisco Veterans Affairs Medical Center, San Francisco, California, USA Center for Vulnerable Populations, Zuckerberg San Francisco General Hospital, University of California, San Francisco, Department of Medicine, San Francisco, California, USA.
² San Francisco Veterans Affairs Medical Center, San Francisco, California, USA Department of Psychiatry, University of California, San Francisco, San Francisco, California, USA Departments of Epidemiology & Biostatistics, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.
³ Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, California, USA Center for Vulnerable Populations, Zuckerberg San Francisco General Hospital, University of California, San Francisco, Department of Medicine, San Francisco, California, USA Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.
⁴ Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, California, USA Northern California Institute for Research and Education, San Francisco, California, USA.
⁵ Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, California, USA Departments of Epidemiology & Biostatistics, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.
⁶ Center for Vulnerable Populations, Zuckerberg San Francisco General Hospital, University of California, San Francisco, Department of Medicine, San Francisco, California, USA Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.

Abstract

Introduction: Advance care planning (ACP) is a process that allows patients to identify their goals for medical care. Traditionally, ACP has focused on completing advance directives; however, we have expanded the ACP paradigm to also prepare patients to communicate their wishes and make informed decisions. To this end, we created an ACP website called PREPARE (http://www.prepareforyourcare.org) to prepare diverse English-speaking and Spanish-speaking older adults for medical decision-making. Here, we describe the study protocol for a randomised controlled efficacy trial of PREPARE in a safety-net setting. The goal is to determine the efficacy of PREPARE to engage diverse English-speaking and Spanish-speaking older adults in a full spectrum of ACP behaviours.

Methods and analysis: We include English-speaking and Spanish-speaking adults from an urban public hospital who are ≥55 years old, have ≥2 chronic medical conditions and have seen a primary care physician ≥2 times in the last year. Participants are randomised to the PREPARE intervention (review PREPARE and an easy-to-read advance directive) or the control arm (only the easy-to-read advance directive). The primary outcome is documentation of an advance directive and/or ACP discussion. Secondary outcomes include ACP behaviour change processes measured with validated surveys (eg, self-efficacy, readiness) and a broad range of ACP actions (eg, choosing a surrogate, identifying goals for care, discussing ACP with clinicians and/or surrogates). Using blinded outcome ascertainment, outcomes will be measured at 1 week and at 3, 6 and 12 months, and compared between study arms using mixed-effects logistic regression and mixed-effects linear, Poisson or negative binomial regression.

Ethics and dissemination: This study has been approved by the appropriate Institutional Review Boards and is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of this study will be disseminated to academic and community stakeholders.

Trial registration numbers: NCT01990235; NCT02072941; Pre-results.

Keywords: advance care planning; health literacy; medical decision making; randomized trial; vulnerable populations.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Publication types

Randomized Controlled Trial

MeSH terms

Advance Care Planning*
Aged
Aged, 80 and over
Chronic Disease
Communication*
Decision Making*
Female
Goals
Health Education / methods*
Health Literacy*
Hispanic or Latino
Hospitals, Public
Humans
Internet
Language*
Male
Middle Aged
Proxy
Quality Improvement*
Research Design

Associated data

ClinicalTrials.gov/NCT01990235
ClinicalTrials.gov/NCT02072941

Abstract

Publication types

MeSH terms

Associated data

Grants and funding