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

Completed

Conditions: Abdominaal Aorta Aneurysma ook Etalagebenen en Spataderen
Abdominal Aortic Aneurysm
enlargement of the abdominal aorta
Intermittent Claudication
Varicose Veins
Varicosis
Windowshoppers Disease
10002363

Registration Number: NL-OMON50185

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 376

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

* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The level of shared decision-making during consultation scored objectively by<br /><br>independent observers on audio-recording with the use of the 5-item OPTION<br /><br>instrument.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The level of disease-specific knowledge in patients The quality of life in<br /><br>patients The level of SDM as perceived by patients The decisional conflict in<br /><br>patients The level of SDM as perceived by physicians The (chosen) treatment The<br /><br>successful introduction of DSTs Process measures of implementation.</p><br>