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Operative Vascular Intervention Decision-making Improvement Using SDM-tools

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21409
Enrollment
376
Registered
2017-06-07
Start date
2018-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Abdominal Aortic Aneurysm, Abdominaal Aorta Aneurysma, Intermittent Claudication, Etalagebenen, Varicose Veins, Spataderen, Shared Decision-Making, Gedeelde besluitvorming, Decision Support Tools, Keuzehulpmiddelen

Interventions

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

Sponsors

Academisch Medisch Centrum Meibergdreef 9 1055 AZ AMSTERDAM ZUIDOOST
Lead Sponsor

Eligibility

Inclusion criteria

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 invalidating IC (Fontaine IIb) • VV for which the patient is considering treatment • Eligible for more than one treatment option • 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 SDM during the doctor-patient consultations in which a treatment decision is to be made.

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

Contacts

Public ContactSylvana de Mik

Meibergdreef 9

s.m.demik@amc.nl+31 (0)20 566 2971

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)