Increasing engagement in advance care planning using a behaviour change model: study protocol for the STAMP randomised controlled trials

INTRODUCTION: Advance care planning (ACP) is a key component of high-quality end-of-life care but is underused. Interventions based on models of behaviour change may fill an important gap in available programmes to increase ACP engagement. Such interventions are designed for broad outreach and flexibility in delivery. The purpose of the Sharing and Talking about My Preferences study is to examine the efficacy of three behaviour change approaches to increasing ACP engagement through two related randomised controlled trials being conducted in different settings (Veterans Affairs (VA) medical centre and community). METHODS AND ANALYSIS: Eligible participants are 55 years or older. Participants in the community are being recruited in person in primary care and specialty outpatient practices and senior living sites, and participants in the VA are recruited by telephone. In the community, randomisation is at the level of the practice or site, with all persons at a given practice/site receiving either computer-tailored feedback with a behaviour stage-matched brochure (computer-tailored intervention (CTI)) or usual care. At the VA, randomisation is at the level of the participant and is stratified by the number of ACP behaviours completed at baseline. Participants are randomised to one of four groups: CTI, motivational interviewing, motivational enhancement therapy or usual care. The primary outcome is completion of four key ACP behaviours: identification of a surrogate decision maker, communication about goals, completing advance directives and ensuring documents are in the medical record. Analysis will be conducted using mixed effects models, taking into account the clustered randomisation for the community study. ETHICS AND RANDOMISATION: The studies have been approved by the appropriate Institutional Review Boards and are being overseen by a Safety Monitoring Committee. The results of these studies will be disseminated to academic audiences and leadership in in the community and VA sites. TRIAL REGISTRATION NUMBERS: NCT03137459 and NCT03103828.