Collaborative care model for managing cardiovascular risk in patients on antipsychotics
Transmural Collaborative Care Model for Cardiovascular Risk Management (CVRM) and Medication Review for Patients Using Antipsychotics: a Cluster Randomised Stepped Wedge Trial
This study tests a new team-based approach to help people on antipsychotic medications lower their heart health risks and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 25 Years to 84 Years |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT05647980 on ClinicalTrials.gov |
What this trial studies
This trial evaluates a collaborative care model designed to manage cardiovascular risk and review medications for patients using atypical antipsychotics. The approach includes an online informational video, a multidisciplinary meeting to assess individual risks and treatment options, and follow-up with a general practitioner to create a personalized action plan. The goal is to improve cardiovascular health and mental quality of life for patients with severe mental disorders. The study aims to address the current inadequacies in monitoring and managing these patients' health risks.
Who should consider this trial
Good fit: Ideal candidates are patients using atypical antipsychotic medication for at least three months and have a 10-year cardiovascular risk of at least 5%.
Not a fit: Patients with a diagnosis of dementia, organic psychosis, or existing cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce cardiovascular risks and improve the quality of life for patients on antipsychotic medications.
How similar studies have performed: Similar collaborative care models have shown promise in managing health risks in patients with mental disorders, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * using atypical antipsychotic medication for at least 3 months at baseline * the atypical antipsychotic medication is prescribed by the general practitioner * a 10-year cardiovascular risk of at least 5% (as measured with QRISK3 score) at baseline Exclusion Criteria: * diagnosis of dementia or organic psychosis * diagnosis of cardiovascular disease (acute myocardial infarction, acute coronary syndrome, heart failure, ischemic stroke, transient ischemic attack, peripheral artery disease, aortic aneurysm or a revascularization procedure, i.e. percutaneous coronary intervention or coronary artery bypass grafting)
Where this trial is running
Nijmegen
- Radboud university medical centre, Dept. Primary and Community Care — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Erik E Bischoff, PhD — Radboud University Medical Center
- Study coordinator: Karlijn KJ van den Brule-Barnhoorn, MD
- Email: karlijn.vandenbrule-barnhoorn@radboudumc.nl
- Phone: +31 24 36 13 237
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.