The Optimizing-Risk-Communication (OptRisk) randomized trial – impact of decision-aid-based consultation on adherence and perception of cardiovascular risk
Received 9 December 2018
Accepted for publication 26 January 2019
Published 27 March 2019 Volume 2019:13 Pages 441—452
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Dr Johnny Chen
Charles Christian Adarkwah,1–3 Nikita Jegan,1 Monika Heinzel-Gutenbrunner,4 Felicitas Kühne,5,6 Uwe Siebert,5–7 Uwe Popert,8 Norbert Donner-Banzhoff,1 Sarah Kürwitz1,9
1Department of General Practice and Family Medicine, University of Marburg, Marburg, Germany; 2Department of Health Services Research and General Practice, Faculty of Life Sciences, University of Siegen, Siegen, Germany; 3Department of Health Services Research, Maastricht University, Maastricht, The Netherlands; 4MH Statistik Beratung, Marburg, Germany; 5Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health and Health Technology Assessment, University for Health Sciences, Medical Informatics and Technology, Innsbruck, Austria; 6Division of Public Health Decision Modelling, Health Technology Assessment and Health Economics, ONCOTYROL – Center for Personalized Cancer Medicine, Innsbruck, Austria; 7Center for Health Decision Science, Department of Health Policy and Management, Harvard School of Public Health, Boston, MA, USA; 8Department of General Practice, University of Göttingen, Göttingen, Germany; 9Department of Public Health, University of Bielefeld, Germany
Background: Shared decision-making is a well-established approach to increasing patient participation in medical decisions. Increasingly, using lifetime-risk or time-to-event (TTE) formats has been suggested, as these might have advantages in comparison with a 10-year risk prognosis, particularly for younger patients, whose lifetime risk for some events may be considerably greater than their 10-year risk. In this study, a randomized trial, the most popular 10-year risk illustration in the decision-aid software Arriba (emoticons), is compared with a newly developed TTE illustration, which is based on a Markov model. The study compares the effect of these two methods of presenting cardiovascular risk to patients on their subsequent adherence to intervention.
Methods: A total of 294 patients were interviewed 3 months after they had had a consultation with their GP on cardiovascular risk prevention. Adherence to behavioral change or medication intervention was measured as the primary outcome. The latter was expressed as a generated score. Furthermore, different secondary outcomes were measured, ie, patient perception of risk and self-rated importance of avoiding a cardiovascular event, as well as patient numeracy, which was used as a proxy for patient health literacy.
Results: Overall, no significant difference in patient adherence was found depending on risk representation. In the emoticon group, the number of interventions had a significant impact on the adherence score (P=0.025). Perception of risk was significantly higher in patients counseled with the TTE risk display, whereas the importance of avoiding a cardiovascular event was rated equally highly in both groups and actually increased over time.
Conclusion: The TTE format is an appropriate means for counseling patients. Adherence is a very complex construct, which cannot be fully explained by our findings. The study results support our call for considering TTE illustrations as a valuable alternative to current decision-support tools covering cardiovascular prevention. Nevertheless, further research is needed to shed light on patient motivation and adherence with regard to cardiovascular risk prevention.
Trial registration: The study was registered at the German Clinical Trials Register and at the WHO International Clinical Trials Register Platform (ICTRP, ID DRKS00004933); registered February 2, 2016 (retrospectively registered).
Keywords: randomized trial, Arriba, decision aid, adherence, risk perception, shared decision-making 10-year prognosis, risk assessment, lifetime risk, time to event, cardiovascular disease
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