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.

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.

Publication types

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

MeSH terms

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

Associated data

  • ClinicalTrials.gov/NCT01990235
  • ClinicalTrials.gov/NCT02072941