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

September 29, 2023 updated by: E. Bischoff, Radboud University Medical Center

Transmural Collaborative Care Model for Cardiovascular Risk Management (CVRM) and Medication Review for Patients Using Antipsychotics: a Cluster Randomised Stepped Wedge Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6525 GA
        • Recruiting
        • Radboud university medical centre, Dept. Primary and Community Care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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
Other: TACTIC
Participants execute the three steps of TACTIC Participants fill in questionnaires Participants take laboratory and biometric tests to measure their cardiovascular risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in QRISK3 score as measured with the QRISK3 calculator (https://qrisk.org/three/)
Time Frame: 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 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
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in Quality of Life (QoL) as measured with the EuroQuality of Life Five Dimensions (EQ-5D-5L) questionnaire
Time Frame: 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)
QoL is measured using the EuroQuality of Life Five Dimensions (EQ-5D-5L) questionnaire, which measures generic quality of life on 5 domains with a 5-point Likert scale. A higher score means a worse healt state in each domain, with a maximum of 5 points.
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
Time Frame: 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 side effects of antipsychotic medication is measured using the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) questionnaire, which assesses side effects of neuroleptic drugs. It has been designed to enable the client to make the rating themselves but can also be administered by mental health workers if the client is unable to complete it. The scale consists of 41 known side effects of neuroleptics. Each 'side-effect' listed is scored on a five point rating scale of 0 - 4, i.e. 0 = 'Not at all' and 4 = Very much. A higher total score means more side-effects. Maximum total score is 84
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)
Time Frame: At 5 months from baseline
Client Satisfaction with care is measured using the CSQ-8, an 8-item questionnaire using a 4-point Likert scale. The sum of 8 sub-scores about different aspects of received care can vary between 8 and 32. Higher scores mean higher satisfaction.
At 5 months from baseline
The change in risk score of developing cardiovascular disease over the next 10 years including a Dutch deprivation score
Time Frame: 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 risk estimation of the QRISK3 score is based on several parameters including the Townsend deprivation score. For the primary outcome the score will be set to 0, as the original score does not apply to the Dutch population. For this secondary outcome the QRISK3 score will be calculated including a Dutch deprivation index. A higher score means a higher risk. Risks may vary between 0% and 100%.
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
Time Frame: 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)
The change in QRISK3 score as a proportion of the maximum achievable change in QRISK3 score is the change in QRISK3 score that has been achieved at the end of follow-up divided by the change in QRISK3 score that could have been achieved when all modifiable risk factors would have been improved. The proportional score may be 1.0 (actual change equals maximum achievable change) or less.
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)
The change in costs related to health care
Time Frame: 1-20 months (depending on the duration of follow-up which differs between the waves in the stepped-wedge trial.
Costs include health care utilization, such as medication use, visits to the general practice, visits to relevant medical specialists, hospitalisation. Costs will be calculated during follow-up time and will be compared with the same period of time prior to start of follow-up.
1-20 months (depending on the duration of follow-up which differs between the waves in the stepped-wedge trial.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development
Onze Huisartsen BV.

Investigators

  • Principal Investigator: Erik E Bischoff, PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10140021910502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Research Information Services (RIS) interface, specifically developed for the Radboud University Nijmegen, will also be used to register and archive our data in the certified DANS EASY archive of KNAW and NWO.

IPD Sharing Time Frame

1-March-2023 until 1-March 2037

IPD Sharing Access Criteria

Data are available on request of the principle investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mental Disorders, Severe

Clinical Trials on TACTIC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe