Transmural Collaborative Care Model for CVRM and Medication Review for Patients Using Antipsychotics
NCT ID: NCT05647980
Last Updated: 2023-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
480 participants
INTERVENTIONAL
2023-03-01
2024-11-01
Brief Summary
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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.
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Detailed Description
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This trial aims to assess the effectiveness of TACTIC regarding predicted cardiovascular risk and mental quality of life.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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TACTIC
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
TACTIC
Participants execute the three steps of TACTIC Participants fill in questionnaires Participants take laboratory and biometric tests to measure their cardiovascular risk
Care as usual
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.
No interventions assigned to this group
Interventions
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TACTIC
Participants execute the three steps of TACTIC Participants fill in questionnaires Participants take laboratory and biometric tests to measure their cardiovascular risk
Eligibility Criteria
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Inclusion Criteria
* 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 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)
25 Years
84 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Onze Huisartsen BV.
UNKNOWN
Radboud University Medical Center
OTHER
Responsible Party
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E. Bischoff
Principle investigator
Principal Investigators
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Erik E Bischoff, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboud university medical centre, Dept. Primary and Community Care
Nijmegen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Radboud U medical centre, Dept. Primary and Community Care
Role: primary
References
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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.
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.
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.
Jakobs KM, van den Brule-Barnhoorn KJ, van Lieshout J, Janzing JGE, Cahn W, Kievit W, Teerenstra S, van den Muijsenbergh M, Biermans MCJ, Bischoff EWMA. Transmural collaborative care model for cardiovascular risk management and medication review in patients using antipsychotics in primary care (TACTIC): A study protocol of an incomplete stepped wedge cluster randomized trial. Contemp Clin Trials Commun. 2025 Jan 9;44:101418. doi: 10.1016/j.conctc.2024.101418. eCollection 2025 Apr.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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10140021910502
Identifier Type: -
Identifier Source: org_study_id
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