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Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial.
BMJ Open. 2016 07 11; 6(7):e011705.BO

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.

Authors+Show Affiliations

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.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.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.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.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.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.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.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.

Pub Type(s)

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

Language

eng

PubMed ID

27401363

Citation

Sudore, Rebecca L., et al. "Improving Advance Care Planning for English-speaking and Spanish-speaking Older Adults: Study Protocol for the PREPARE Randomised Controlled Trial." BMJ Open, vol. 6, no. 7, 2016, pp. e011705.
Sudore RL, Barnes DE, Le GM, et al. Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial. BMJ Open. 2016;6(7):e011705.
Sudore, R. L., Barnes, D. E., Le, G. M., Ramos, R., Osua, S. J., Richardson, S. A., Boscardin, J., & Schillinger, D. (2016). Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial. BMJ Open, 6(7), e011705. https://doi.org/10.1136/bmjopen-2016-011705
Sudore RL, et al. Improving Advance Care Planning for English-speaking and Spanish-speaking Older Adults: Study Protocol for the PREPARE Randomised Controlled Trial. BMJ Open. 2016 07 11;6(7):e011705. PubMed PMID: 27401363.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial. AU - Sudore,Rebecca L, AU - Barnes,Deborah E, AU - Le,Gem M, AU - Ramos,Roberto, AU - Osua,Stacy J, AU - Richardson,Sarah A, AU - Boscardin,John, AU - Schillinger,Dean, Y1 - 2016/07/11/ PY - 2016/7/13/entrez PY - 2016/7/13/pubmed PY - 2017/12/5/medline KW - advance care planning KW - health literacy KW - medical decision making KW - randomized trial KW - vulnerable populations SP - e011705 EP - e011705 JF - BMJ open JO - BMJ Open VL - 6 IS - 7 N2 - 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. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/27401363/Improving_advance_care_planning_for_English_speaking_and_Spanish_speaking_older_adults:_study_protocol_for_the_PREPARE_randomised_controlled_trial_ L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=27401363 DB - PRIME DP - Unbound Medicine ER -