Improving shared decision-making in vascular surgery by implementing decision support tools: study protocol for the stepped-wedge cluster-randomised OVIDIUS trial

S M L De Mik,D T Ubbink,R Balm,D A Legemate,F E Stubenrouch

doi:10.1186/s12911-020-01186-y

Abstract

BackgroundShared decision-making improves the quality of patient care. Unfortunately, shared decision-making is not yet common practice among vascular surgeons. Thus, decision support tools were developed to assist vascular surgeons and their patients in using shared decision-making. This trial aims to evaluate the effectiveness and implementation of decision support tools to improve shared decision-making during vascular surgical consultations in which a treatment decision is to be made.MethodsThe study design is a multicentre stepped-wedge cluster-randomised trial. Eligible patients are adult patients, visiting the outpatient clinic of a participating medical centre for whom several treatment options are feasible and who face a primary treatment decision for their abdominal aortic aneurysm, carotid artery disease, intermittent claudication, or varicose veins. Patients and vascular surgeons in the intervention group receive decision support tools that may help them adopt shared decision-making when making the final treatment decision. These decision support tools are decision aids, consultation cards, decision cards, and a practical training. Decision aids are informative websites that help patients become more aware of the pros and cons of the treatment options and their preferences regarding the treatment choice. Consultation cards with text or decision cards with images are used by vascular surgeons during consultation to determine which aspect of a treatment is most important to their patient. In the training vascular surgeons can practice shared decision-making with a patient actor, guided by a medical psychologist. This trial aims to include 502 vascular surgical patients to achieve a clinically relevant improvement in shared decision-making of 10 out of 100 points, using the 5-item OPTION instrument to score the audio-recordings of consultations.DiscussionIn the OVIDIUS trial the available decision support tools for vascular surgical patients are implemented in clinical practice. We will evaluate whether these tools actually improve shared decision-making in the consultation room. The stepped-wedge cluster-randomised study design will ensure that at the end of the study all participating centres have implemented at least some of the decision support tools and thereby a certain level of shared decision-making.Trial registrationNetherlands Trial Registry, NTR6487. Registered 7 June 2017. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6487

Highlights

Shared decision-making improves the quality of patient care
In the Operative Vascular Intervention Decision-making Improvement Using Sdm-tools (OVIDIUS) trial the available decision support tools for vascular surgical patients are implemented in clinical practice
The use of shared decision-making (SDM) is still limited amongst vascular surgeons

Summary

Introduction

Shared decision-making improves the quality of patient care. Decision support tools were developed to assist vascular surgeons and their patients in using shared decision-making. This trial aims to evaluate the effectiveness and implementation of decision support tools to improve shared decision-making during vascular surgical consultations in which a treatment decision is to be made. In recent years it has been acknowledged that the incorporation of the patients’ preferences, known as shared decision-making (SDM), improves quality of care by enhancing patient satisfaction and therapy adherence [1, 2]. Studies show that in the Netherlands, the level of SDM is limited among vascular surgeons and that patients are informed inconsistently about their disease and treatment options [7, 8]

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