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

NCT05647980 | Unknown

• 1 other identifier: 10140021910502
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorders, Severe

Keywords

Primary health care; Antipsychotics; Cardiovascular risk; Collaborative care; Deprescribing; Off label

Outcome Measures

Primary Outcomes (2)

• The change in QRISK3 score as measured with the QRISK3 calculator (https://qrisk.org/three/)

  The risk score of developing cardiovascular disease over the next 10 years is estimated using the QRISK®3 algorithm (https://qrisk.org/three/), which calculates a person's ten-year risk of cardiovascular disease by taking multiple risk parameters into account. A higher score means a higher risk. Risks may vary between 0% and 100%. The parameter Townsend deprivation score will be set to 0 (as advised by its developers), meaning neither deprived nor affluent, as this score does not apply to the Dutch population.

  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)

• The change in Mental Health, as measured with the Mental Health Inventory questionnaire

  Mental Health is measured using the five-item version of the Mental Health Inventory (MHI) questionnaire. The MHI-5 is a derivative of the 36-item short form (SF-36) health survey, and assesses symptoms of depression and anxiety, loss of behavioural or emotional control, and psychological well-being in the prior four weeks. Scores range from 0 to 100, lower scores are worse, and patients with a score ≥60 are considered mentally healthy.

  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 (6)

• The change in Quality of Life (QoL) as measured with the EuroQuality of Life Five Dimensions (EQ-5D-5L) questionnaire

  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)

• The change in Side effects of antipsychotic medication, as measured with the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) questionnaire

  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)

• The change in Client Satisfaction, as measured with the 8-item Client Satisfaction Questionnaire (CSQ-8)

  At 5 months from baseline

• The change in risk score of developing cardiovascular disease over the next 10 years including a Dutch deprivation score

  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)

• The change in QRISK3 score as proportion of the maximum achievable change in QRISK3 score

  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)

Study Arms (2)

TACTIC

EXPERIMENTAL

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

Other: TACTIC

Care as usual

NO INTERVENTION

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.

Interventions

TACTIC OTHER

Participants execute the three steps of TACTIC Participants fill in questionnaires Participants take laboratory and biometric tests to measure their cardiovascular risk

TACTIC

Eligibility Criteria

• Age: 25 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Onze Huisartsen BV.: collaborator

Study Sites (1)

Radboud university medical centre, Dept. Primary and Community Care

Nijmegen, 6525 GA, Netherlands

RECRUITING

Related Publications (4)

• 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.

  PMID: 33131496 BACKGROUND

• 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.

  PMID: 32727372 BACKGROUND

• 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.

  PMID: 35796600 BACKGROUND

• 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.

  PMID: 39897941 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Erik E Bischoff, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karlijn KJ van den Brule-Barnhoorn, MD

CONTACT

+31 24 36 13 237; karlijn.vandenbrule-barnhoorn@radboudumc.nl

Kirsti KM Jakobs, MD

CONTACT

+31 61 24 70 221; Kirsti.Jakobs@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Incomplete stepped wedge cluster randomised trial

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: December 13, 2022
• Study Start: March 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1-March-2023 until 1-March 2037
• Access Criteria: Data are available on request of the principle investigator

Locations

NL (1)