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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mental Disorders, Severe

Intervention / Treatment
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* Other: TACTIC


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Incomplete stepped wedge cluster randomised trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TACTIC<br>Participants in the TACTIC intervention will be provided a 3-step approach, i.e. an online information video to inform patients about the cardiovascular risks of antipsychotic use and the procedures of the multidisciplinary meeting 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 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<br>* Participants execute the three steps of TACTIC Participants fill in questionnaires Participants take laboratory and biometric tests to measure their cardiovascular risk<br>|
| No Intervention: Care as usual<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 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 | 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) | 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 | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary health care, Antipsychotics, Cardiovascular risk, Collaborative care, Deprescribing, Off label