TY - JOUR
T1 - Shared decision making for stroke prevention in atrial fibrillation
T2 - Study protocol for a randomized controlled trial
AU - Kunneman, Marleen
AU - Branda, Megan E.
AU - Noseworthy, Peter A.
AU - Linzer, Mark
AU - Burnett, Bruce
AU - Dick, Sara
AU - Spencer-Bonilla, Gabriela
AU - Fernandez, Cara A.
AU - Gorr, Haeshik
AU - Wambua, Mike
AU - Keune, Shelly
AU - Zeballos-Palacios, Claudia
AU - Hargraves, Ian
AU - Shah, Nilay D.
AU - Montori, Victor M.
N1 - Publisher Copyright:
© 2017 The Author(s).
PY - 2017/9/29
Y1 - 2017/9/29
N2 - 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.
AB - 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.
KW - Anticoagulation
KW - Atrial fibrillation
KW - Communication
KW - Conversation aid
KW - Decision aid
KW - Medication adherence
KW - Medication uptake
KW - Shared decision making
UR - http://www.scopus.com/inward/record.url?scp=85030164973&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85030164973&partnerID=8YFLogxK
U2 - 10.1186/s13063-017-2178-y
DO - 10.1186/s13063-017-2178-y
M3 - Article
C2 - 28962662
AN - SCOPUS:85030164973
SN - 1745-6215
VL - 18
JO - Trials
JF - Trials
IS - 1
M1 - 443
ER -