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Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial
Marleen Kunneman1, Megan E Branda1,2, Peter A Noseworthy1,3,4
1Knowledge and Evaluation Research Unit, Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Insights
This study evaluates the ANTICOAGULATION CHOICE tool for improving shared decision-making (SDM) in nonvalvular atrial fibrillation (AF) patients. The tool aims to enhance treatment choices and adherence for stroke risk reduction.
Area of Science:
- Cardiology
- Health Services Research
- Patient Decision Aids
Background:
- Nonvalvular atrial fibrillation (AF) poses a significant stroke risk.
- Individualized treatment decisions are crucial for managing AF-related stroke risk.
- Shared decision-making (SDM) is recommended to align treatment with patient values.
Purpose of the Study:
- To assess the ANTICOAGULATION CHOICE conversation tool's impact on SDM quality in AF patients.
- To evaluate the tool's influence on anticoagulation uptake and adherence.
- To determine if the tool promotes patient-centered care in AF management.
Main Methods:
- Multicenter, randomized trial comparing the ANTICOAGULATION CHOICE tool to usual care.
- Inclusion of 999 patients with nonvalvular AF and stroke risk (CHA 2DS 2-VASc score 2206 1/2).
- Primary outcome: perceived SDM quality (knowledge transfer, concordance, communication, satisfaction); secondary outcomes: anticoagulant use, adherence, stroke/bleeding events.
Main Results:
- The study is designed to provide a precise measure of the tool's effect.
- Anticoagulant use, choice, and adherence will be analyzed from medical and pharmacy records.
- Clinical outcomes such as strokes and bleeding events will be tracked.
Conclusions:
- The ANTICOAGULATION CHOICE tool is expected to enhance SDM quality in AF patients.
- The study will elucidate the tool's effect on treatment decisions and adherence.
- Findings will inform the use of decision aids for optimizing anticoagulation in AF.
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.
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