Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial

Marleen Kunneman, Megan E Branda, Peter A Noseworthy, Mark Linzer, Bruce Burnett, Sara Dick, Gabriela Spencer-Bonilla, Cara A Fernandez, Haeshik Gorr, Mike Wambua, Shelly Keune, Claudia Zeballos-Palacios, Ian Hargraves, Nilay D Shah, Victor M Montori, Marleen Kunneman, Megan E Branda, Peter A Noseworthy, Mark Linzer, Bruce Burnett, Sara Dick, Gabriela Spencer-Bonilla, Cara A Fernandez, Haeshik Gorr, Mike Wambua, Shelly Keune, Claudia Zeballos-Palacios, Ian Hargraves, Nilay D Shah, Victor M Montori

Abstract

Background: Nonvalvular atrial fibrillation (AF) is a common ongoing health problem that places patients at risk of stroke. Whether and how a patient addresses this risk depends on each patient's goals, context, and values. Consequently, leading cardiovascular societies recommend using shared decision making (SDM) to individualize antithrombotic treatment in patients with AF. The aim of this study is to assess the extent to which the ANTICOAGULATION CHOICE conversation tool promotes high-quality SDM and influences anticoagulation uptake and adherence in patients with AF at risk of strokes.

Methods: This study protocol describes a multicenter, encounter-level, randomized trial to assess the effect of using the ANTICOAGULATION CHOICE conversation tool in the clinical encounter, compared to usual care. The participating centers include an academic hospital system, a suburban community group practice, and an urban safety net hospital, all in Minnesota, USA. Patients with ongoing nonvalvular AF at risk of strokes (CHA2DS2-VASc score ≥ 1 in men, or ≥ 2 in women) will be eligible for participation. We aim to include 999 patients and their clinicians. The primary outcome is the quality of SDM as perceived by participants, and as assessed by a post-encounter survey that ascertains (a) knowledge transfer, (b) concordance of the decision made, (c) quality of communication, and (d) satisfaction with the decision-making process. Recordings of encounters will be reviewed to assess the extent of patient involvement and how participants use the tool (fidelity). Anticoagulant use, choice of agent, and adherence will be drawn from patients' medical and pharmacy records. Strokes and bleeding events will be drawn from patient records.

Discussion: This study will provide a valid and precise measure of the effect of the ANTICOAGULATION CHOICE conversation tool on SDM quality and processes, and on the treatment choices and adherence to therapy among AF patients at risk of stroke.

Trial registration: ClinicalTrials.gov, NCT02905032 . Registered on 9 September 2016.

Keywords: Anticoagulation; Atrial fibrillation; Conversation aid; Decision aid; Medication adherence; Medication uptake; Shared decision making; communication.

Conflict of interest statement

Authors’ information

Not applicable.

Ethics approval and consent to participate

Institutional Review Board approval has been obtained from the lead coordinating center, the Mayo Clinic (approval number 16-005409) and from the two participating external sites. All participating patients and clinicians must provide written informed consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of enrollment, interventions and assessments. Notes: (1) patients who do not have utilization within enrolling healthcare system will be contacted via phone for verification of safety data (strokes and bleeds). If there is no information in the record and follow up is necessary we will call patients the maximum number allowed by the IRB followed by a postal survey; (2) pharmacist records will be requested for 12 months prior to enrollment through 10 months post enrollment. INR international normalized ratio, EMR electronic medical record

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