Transmural Collaborative Care Model for CVRM and Medication Review for Patients Using Antipsychotics (TACTIC)

Radboud University Medical Center

Status: Enrolling

Conditions: Mental Disorders, Severe

Treatments: Other: TACTIC

Study type: Interventional

Funder types: Other

Identifiers

NCT05647980

10140021910502

Details and patient eligibility

About

Currently, monitoring of usage and effects of antipsychotic treatment and cardiovascular risk screening in patients with severe mental illness or antipsychotic treatment is not sufficient.

A transmural collaborative care model for cardiovascular risk management and medication review for patients using atypical antipsychotics in general practice (TACTIC) was developed. This trial aims to assess the effectiveness of TACTIC regarding predicted cardiovascular risk and mental quality of life.

Full description

It is well established that patients with severe mental illness and patients treated with atypical antipsychotics have excess metabolic dysfunction and are at an increased risk of cardiovascular disease. Currently, monitoring of usage and effects of antipsychotic treatment and cardiovascular risk screening in patients with severe mental illness or antipsychotic treatment is not sufficient. General practitioners experience barriers regarding knowledge, collaboration with psychiatrists, and patient compliance. To overcome these barriers a transmural collaborative care model for cardiovascular risk management and medication review for patients using atypical antipsychotics in general practice (TACTIC) was developed. TACTIC is a one-time transmural intervention comprising three steps: 1) an online information video to inform patients about the cardiovascular risks of antipsychotic use and the procedures of the multidisciplinary meeting, 2) a multidisciplinary meeting with the patient to review his or her antipsychotic use and cardiovascular risk and to provide tailored treatment advice, and 3) a follow-up contact with the general practitioner to translate the treatment advice into an individualised action plan through shared decision making.

This trial aims to assess the effectiveness of TACTIC regarding predicted cardiovascular risk and mental quality of life.

Enrollment: 480 estimated patients

Sex: All

Ages: 25 to 84 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

480 participants in 2 patient groups

TACTIC

Experimental group

Description:

Participants in the TACTIC intervention will be provided a 3-step approach, i.e. 1. an online information video to inform patients about the cardiovascular risks of antipsychotic use and the procedures of the multidisciplinary meeting 2. a multidisciplinary meeting with their general practitioner, the primary care nurse, a psychiatrist, and an experience expert to discuss cardiovascular risk and side effect and to provide personalised treatment options 3. a consultation with their general practitioner to translate treatment options into an individualised treatment plan including lifestyle and medication treatment and monitoring frequency, based on shared-decision making

Treatment:

Other: TACTIC

Care as usual

No Intervention group

Description:

Care as usual, i.e. renewal of prescriptions for antipsychotics by the general practitioner without multidisciplinary treatment advice and without the use of scheduled and structured monitoring visits.