NCT06871514

Effectiveness of Decision Support for Cardiovascular Risk Management in People With Cardiovascular Disease

2-DECIDE: A Stepped-Wedge Multicenter Study on the Effectiveness of a Multicomponent Intervention With Shared Decision-Making to Improve Cardiovascular Risk Management in Adults With Established Atherosclerotic Cardiovascular Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: dr.Frank L.J. Visseren · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to improve the way patients with cardiovascular diseases are informed about their treatment options. It explores methods to support shared decision-making between patients and doctors. In some cases, doctors will take extra time to discuss treatment options in detail. To assess the impact, some patients will be asked to complete questionnaires after their clinic visits.

Conditions

• Atherosclerotic Cardiovascular Diseases
• Shared-decision Making

Interventions

Type	Name	Description
OTHER	2-DECIDE intervention: decision support for cardiovascular risk management	The 2-DECIDE intervention consists of: * Training of healthcare providers in implementing shared decision-making during clinical consultations. * At least one initial extended outpatient consultation with a trained physician to ensure adequate time for actual understanding of treatment options. * Decision support based on U-prevent * Clear communication to the patient is provided in an easily comprehensible format, including pre-visit information, and a post-visit handout of the information and decisions made using the U-prevent medical device. Additionally, the general practitioner receives a letter detailing the outcome and rationale of the shared decision, along with the individual estimates that have informed the treatment choice.
OTHER	No Intervention: usual care	Usual care

Timeline

• Start date: 2025-02-18
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-03-12
• Last updated: 2025-03-12

Locations

8 sites across 1 country: Netherlands