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1 Department of General Practice/Family Medicine, Phillips-University Marburg, Marburg, Germany
2 Department of Bioethics/Clinical Ethics, Phillips-University Marburg, Marburg, Germany
3 Department of Family Medicine, Phillips-University Marburg, Marburg, Germany
4 Institute of General Practice, Family Medicine and Prevention, Paracelsus Medical University, Salzburg, Austria
5 Department of Medical Biometry and Epidemiology, University of Hamburg, Hamburg, Germany
6 Statistician Center for Clinical Studies, University Hospital, Regensburg, Germany
CORRESPONDING AUTHOR: Tanja Krones, MD, Klinikum der Philipps-Universität Marburg, Baldingerstrasse, 35033, Marburg, krones{at}med.uni-marburg.de
PURPOSE We wanted to determine the effect of promoting the effective communication of absolute cardiovascular disease (CVD) risk and shared decision making through disseminating a simple decision aid for use in family practice consultations.
METHODS The study was based on a pragmatic, cluster randomized controlled trial (phase III) with continuing medical education (CME) groups of family physicians as the unit of randomization. In the intervention arm, 44 physicians (7 CME groups) consecutively recruited 550 patients in whom cholesterol levels were measured. Forty-seven physicians in the control arm (7 CME groups) similarly included 582 patients. Four hundred sixty patients (83.6%) of the intervention arm and 466 patients (80.1%) of the control arm were seen at follow-up. Physicians attended 2 interactive CME sessions and received a booklet, a paper-based risk calculator, and individual summary sheets for each patient. Control physicians attended 1 CME-session on an alternative topic. Main outcome measures were patient satisfaction and participation after the index consultation, change in CVD risk status, and decisional regret at 6 months follow-up.
RESULTS Intervention patients were significantly more satisfied with process and result (Patient Participation Scale, difference 0.80, P<.001). Decisional regret was significantly lower at follow-up (difference 3.39, P = .02). CVD risk decreased in both groups without a significant difference between study arms.
CONCLUSION A simple transactional decision aid based on calculating absolute individual CVD risk and promoting shared decision making in CVD prevention can be disseminated through CME groups and may lead to higher patient satisfaction and involvement and less decisional regret, without negatively affecting global CVD risk.
Key Words: Shared decision-making decision aids cardiovascular diseases risk primary health care continuing medical education bioethics chronic care decision support
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