Transmural Collaborative Care Model for Cardiovascular Risk Management (CVRM) and Medication Review for Patients Using Antipsychotics: a Cluster Randomised Stepped Wedge Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- The change in QRISK3 score as measured with the QRISK3 calculator (https://qrisk.org/three/)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
The change in QRISK3 score as measured with the QRISK3 calculator (https://qrisk.org/three/)
时间窗: 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.
The change in Mental Health, as measured with the Mental Health Inventory questionnaire
时间窗: 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.
次要结局
- 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))
- The change in costs related to health care(1-20 months (depending on the duration of follow-up which differs between the waves in the stepped-wedge trial.)
- 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))
研究者
E. Bischoff
Principle investigator
Radboud University Medical Center