|- candidate number||27358|
|- NTR Number||NTR6487|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-jun-2017|
|- Secondary IDs||18954/SB157001 AMR project code|
|- Public Title||Operative Vascular Intervention Decision-making Improvement Using SDM-tools
|- Scientific Title||A multicentre stepped-wedge cluster-randomised trial studying the level of shared decision-making during vascular surgical consultation before and after the introduction of decision support tools. |
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Abdominal Aortic Aneurysm, Shared decision making, Intermittent claudication, Carotid artery stenosis, Varicose veins|
|- Inclusion criteria|| Age ≥ 18 years |
Newly diagnosed patients with an asymptomatic AAA and which has grown to 5,5 cm or more.
Newly diagnosed patients with a symptomatic CAS of >70% or >50% in men, that are diagnosed within 6 months or 12 weeks, respectively, since the onset of symptoms.20
Newly diagnosed patients with invalidating IC (Fontaine IIb)
VV for which the patient is considering treatment
Eligible for more than one treatment option
Written informed consent
|- Exclusion criteria|| Insufficient understanding of the Dutch language or cognitively unable to complete Dutch questionnaires. |
Life expectancy less than 1 year
Patients requiring emergency surgery
ASA IV patients
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2018|
|- planned closingdate||1-mei-2019|
|- Target number of participants||502|
|- Interventions||Decision support tools: Decision Aids, Decision Tables, Decision Cards, Training|
|- Primary outcome||The level of SDM during the doctor-patient consultations in which a treatment decision is to be made.|
|- Secondary outcome|| The level of disease-specific knowledge in patients|
The quality of life in patients
The level of SDM as perceived by patients
The decisional conflict in patients
The level of SDM as perceived by physicians
The (chosen) treatment
The successful introduction of DSTs
Process measures of implementation
|- Timepoints|| Baseline (before consultation)|
Directly after consultation
4 weeks after consultation or just before endovascular or open surgical treatment
6 weeks after treatment.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Sylvana de Mik|
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|AMC Foundation, Academic Medical Center (AMC), Medical Research B.V.|
|- Brief summary||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, carotid artery stenosis, 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.
|- Main changes (audit trail)|
|- RECORD||7-jun-2017 - 11-jan-2018|