RecruitingNot ApplicableNCT06871514

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


Sponsor

dr.Frank L.J. Visseren

Enrollment

1,200 participants

Start Date

Feb 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 2-DECIDE intervention: decision support for cardiovascular risk management and No Intervention: usual care for people with atherosclerotic cardiovascular diseases and shared decision making. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 40 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHER2-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.

OTHERNo Intervention: usual care

Usual care


Locations(8)

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Meander Medisch Centrum

Amersfoort, Netherlands

Deventer Ziekenhuis

Deventer, Netherlands

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Radboudumc

Nijmegen, Netherlands

HagaZiekenhuis

The Hague, Netherlands

Diakonessenhuis

Utrecht, Netherlands

UMC Utrecht

Utrecht, Netherlands

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NCT06871514


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