Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Meibergdreef 9, 1105AZ, Amsterdam, The Netherlands.
BMC Med Inform Decis Mak. 2020 Jul 23;20(1):172. doi: 10.1186/s12911-020-01186-y.
Shared 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.
The 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.
In 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.
Netherlands Trial Registry, NTR6487 . Registered 7 June 2017. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6487.
共同决策可提高患者护理质量。遗憾的是，血管外科医生尚未普遍采用共同决策。因此，开发了决策支持工具来协助血管外科医生及其患者使用共同决策。本试验旨在评估决策支持工具的有效性和实施情况，以改善血管外科会诊中需要做出治疗决策时的共同决策。
研究设计为多中心阶梯式楔形集群随机试验。合格的患者为成年患者，他们正在参加医疗中心的门诊就诊，有几种可行的治疗选择，并且需要对其腹主动脉瘤、颈动脉疾病、间歇性跛行或静脉曲张做出主要治疗决策。干预组的患者和血管外科医生将接受决策支持工具，这些工具可能有助于他们在做出最终治疗决策时采用共同决策。这些决策支持工具包括决策辅助工具、咨询卡、决策卡和实践培训。决策辅助工具是帮助患者了解治疗选择的优缺点以及他们对治疗选择的偏好的信息网站。在咨询期间，血管外科医生会使用带有文本的咨询卡或带有图像的决策卡来确定治疗的哪一方面对患者最重要。在培训中，血管外科医生可以在医学心理学家的指导下，与患者扮演者一起练习共同决策。本试验旨在纳入 502 例血管外科患者，使用 OPTION 工具（用于对咨询录音进行评分的 5 项工具）评估，以实现 10 分制中 10 分的共同决策的临床相关改善。
在 OVIDIUS 试验中，将在临床实践中实施针对血管外科患者的现有决策支持工具。我们将评估这些工具是否真的能改善咨询室中的共同决策。阶梯式楔形集群随机设计将确保在研究结束时，所有参与中心都至少实施了一些决策支持工具，从而实现了一定程度的共同决策。
荷兰试验注册处，NTR6487。注册日期：2017 年 6 月 7 日。网址：http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6487。
