Clinical trial NCT05647980: Transmural Collaborative Care Model for CVRM and Medication Review for Patients Using Antipsychotics
Official title: Transmural Collaborative Care Model for Cardiovascular Risk Management (CVRM) and Medication Review for Patients Using Antipsychotics: a Cluster Randomised Stepped Wedge Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Disorders, Severe
Keywords: Primary health care
Antipsychotics
Cardiovascular risk
Collaborative care
Deprescribing
Off label
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Onze Huisartsen BV.
First posted: 2022-12-13
Enrollment: 480
Sex: ALL
Minimum age (years): 25
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Incomplete stepped wedge cluster randomised trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: The change in QRISK3 score as measured with the QRISK3 calculator (https://qrisk.org/three/)
timeFrame: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
measure: The change in Mental Health, as measured with the Mental Health Inventory questionnaire
timeFrame: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
Secondary outcomes:
measure: The change in Quality of Life (QoL) as measured with the EuroQuality of Life Five Dimensions (EQ-5D-5L) questionnaire
timeFrame: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
measure: The change in Side effects of antipsychotic medication, as measured with the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) questionnaire
timeFrame: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
measure: The change in Client Satisfaction, as measured with the 8-item Client Satisfaction Questionnaire (CSQ-8)
timeFrame: At 5 months from baseline
measure: The change in risk score of developing cardiovascular disease over the next 10 years including a Dutch deprivation score
timeFrame: Measurements at baseline, at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
measure: The change in QRISK3 score as proportion of the maximum achievable change in QRISK3 score
timeFrame: Measurements at baseline baseline at 5, 10, 15 and 20 months (depending on the specific wave in the stepped-wedge trial in which follow-up starts)
measure: The change in costs related to health care
timeFrame: 1-20 months (depending on the duration of follow-up which differs between the waves in the stepped-wedge trial.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical centre, Dept. Primary and Community Care
Study officials:
affiliation: Radboud University Medical Center
name: Erik E Bischoff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bischoff EWMA, Jakobs KM, Assendelft WJJ. Cardiovascular risk management in patients using antipsychotics: it is time to take action. BMC Med. 2020 Nov 2;18(1):339. doi: 10.1186/s12916-020-01811-7. No abstract available.
citation: Jakobs KM, Posthuma A, de Grauw WJC, Schalk BWM, Akkermans RP, Lucassen P, Schermer T, Assendelft WJJ, Biermans MJC. Cardiovascular risk screening of patients with serious mental illness or use of antipsychotics in family practice. BMC Fam Pract. 2020 Jul 29;21(1):153. doi: 10.1186/s12875-020-01225-7.
citation: Jakobs K, Lautan L, Lucassen P, Janzing J, van Lieshout J, Biermans MCJ, Bischoff EWMA. Cardiovascular risk management in patients with severe mental illness or taking antipsychotics: A qualitative study on barriers and facilitators among dutch general practitioners. Eur J Gen Pract. 2022 Dec;28(1):191-199. doi: 10.1080/13814788.2022.2092093.