Operative Vascular Intervention Decision-making Improvement Using SDM-tools

Rationale: Previous studies show that the quality of patient care can be improved by using shared decision-making. Unfortunately, the use of shared decision-making is poor among vascular surgeons. Decision support tools are developed to assist vascular patients and their physicians in using SDM.



Objective: Our main objective is to improve the level of SDM during vascular surgical consultations in which a treatment decision is to be made, with the use of DSTs. Our secondary objectives are to improve SDM as experienced by both patients and physicians, patients’ disease-specific knowledge and quality of life, a decrease in decisional conflict, a difference in chosen treatment, the successful introduction of DSTs and a cost-effectiveness study.



Study design: Our study design is a multicentre stepped-wedge cluster-randomised trial in 16 medical centres.



Study population: All adult patients, visiting the outpatient clinic of a participating vascular surgery department or vascular medical centre for whom several treatment options are feasible and who need to decide on a primary treatment of their abdominal aortic aneurysm, intermittent claudication or varicose veins, are eligible.



Intervention: Our study does not entail a (new) medicinal or surgical intervention. Patients and physicians in the intervention group are presented with decision support tools that will help them to use shared decision-making to make the final treatment decision. These decision support tools consist of a website that the patient can access to obtain information and that created awareness on the patients preferences with regard to the treatment options, and decision tables or cards that physicians can use to determine which aspect of a treatment is most important to their patient. In addition, the physicians are provided a training session about shared decision-making and the use of decision support tools.



Main study parameters/endpoints: The level of shared decision-making during consultation scored objectively by independent observers on audio-recording with the use of the 5-item OPTION instrument.



Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the intervention group are required to invest their time to use the decision aid and consider their preferences. Previously discovered benefits for patients are improved quality of care, enhanced patient satisfaction and therapy adherence. It also, prevents undesired care and a reduction in patient opting for major treatments. The use of decision support tools or shared decision-making shows no adverse effects on health outcomes.

Providing vascular surgical patients and vascular surgeons with decision support tools will improve the level of shared decision-making during consultation, increase disease-specific knowledge and quality of life and decrease decisional conflict.

• Baseline (before consultation)

• During consultation

• Directly after consultation

• 4 weeks after consultation or just before endovascular or open surgical treatment

• 6 weeks after treatment.

Decision support tools: Decision Aids, Decision Tables, Decision Cards, Training