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Operative Vascular Intervention Decision-making Improvement Using SDM-tools: A multicentre stepped-wedge cluster-randomised trial

Operative Vascular Intervention Decision-making Improvement Using SDM-tools: A multicentre stepped-wedge cluster-randomised trial - OVIDIUS Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50185
Enrollment
376
Registered
2017-10-10
Start date
2018-01-04
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominaal Aorta Aneurysma ook Etalagebenen en Spataderen Abdominal Aortic Aneurysm enlargement of the abdominal aorta Intermittent Claudication Varicose Veins Varicosis Windowshoppers Disease

Interventions

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 de

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Eligible for more than one treatment option * Age * 18 years * Newly diagnosed patients with an asymptomatic AAA and which has grown to 5 cm or more in women and 5,5 cm or more in men. * Patients with invalidating IC (Fontaine IIb) * Patients with VV for which the patient is considering treatment * Written informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)