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

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2025-01-09 DOI:10.1016/j.conctc.2024.101418

Kirsti M. Jakobs , Karlijn J. van den Brule-Barnhoorn , Jan van Lieshout , Joost G.E. Janzing , Wiepke Cahn , Wietske Kievit , Steven Teerenstra , Maria van den Muijsenbergh , Marion C.J. Biermans , Erik W.M.A. Bischoff

{"title":"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","authors":"Kirsti M. Jakobs , Karlijn J. van den Brule-Barnhoorn , Jan van Lieshout , Joost G.E. Janzing , Wiepke Cahn , Wietske Kievit , Steven Teerenstra , Maria van den Muijsenbergh , Marion C.J. Biermans , Erik W.M.A. Bischoff","doi":"10.1016/j.conctc.2024.101418","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>It is well established that patients with severe mental illness and those treated with atypical antipsychotics (AAPs) are at an increased risk of cardiovascular disease. However, primary care currently lacks adequate monitoring of AAP usage, its effects, and the associated cardiovascular risk. We have developed TACTIC, a transmural collaborative care model for patients using AAPs prescribed by the general practitioner (GP) to address the issues of potential overtreatment with AAPs and undertreatment for cardiovascular risk. TACTIC comprises three steps: an informative video for patients, a multidisciplinary meeting, and a shared decision-making consultation with the GP.</div></div><div><h3>Objectives</h3><div>To evaluate TACTIC's effectiveness on cardiovascular risk and mental health and its cost-effectiveness.</div></div><div><h3>Methods</h3><div>We will conduct an incomplete stepped wedge cluster randomized trial in the Netherlands.</div><div>40 GP-nurse clusters are randomized into four waves. Each cluster recruits adult patients (25–85 years), without prior diagnoses of dementia, delirium, or cardiovascular disease, for whom the GP prescribes AAPs. Every five months, a new wave starts with TACTIC. Measurements are taken before the intervention starts and every 5 months until the study concludes. Primary outcomes are cardiovascular risk and mental health as measured with the QRISK3 score and MHI5, respectively. The economic evaluation consists of two cost-utility analyses, one on the data collected alongside the trial and one based on a model extrapolating the trial data to a 10-year horizon. We will also evaluate the process of delivering TACTIC.</div></div><div><h3>Conclusion</h3><div>This study will assess TACTIC's (cost)effectiveness and provide insights for successful delivery in general practice.</div></div><div><h3>Clinical trials registration</h3><div>clinicaltrials.gov NCT05647980.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101418"},"PeriodicalIF":1.4000,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11787019/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865424001650","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

Abstract

Background

It is well established that patients with severe mental illness and those treated with atypical antipsychotics (AAPs) are at an increased risk of cardiovascular disease. However, primary care currently lacks adequate monitoring of AAP usage, its effects, and the associated cardiovascular risk. We have developed TACTIC, a transmural collaborative care model for patients using AAPs prescribed by the general practitioner (GP) to address the issues of potential overtreatment with AAPs and undertreatment for cardiovascular risk. TACTIC comprises three steps: an informative video for patients, a multidisciplinary meeting, and a shared decision-making consultation with the GP.

Objectives

To evaluate TACTIC's effectiveness on cardiovascular risk and mental health and its cost-effectiveness.

Methods

We will conduct an incomplete stepped wedge cluster randomized trial in the Netherlands.

40 GP-nurse clusters are randomized into four waves. Each cluster recruits adult patients (25–85 years), without prior diagnoses of dementia, delirium, or cardiovascular disease, for whom the GP prescribes AAPs. Every five months, a new wave starts with TACTIC. Measurements are taken before the intervention starts and every 5 months until the study concludes. Primary outcomes are cardiovascular risk and mental health as measured with the QRISK3 score and MHI5, respectively. The economic evaluation consists of two cost-utility analyses, one on the data collected alongside the trial and one based on a model extrapolating the trial data to a 10-year horizon. We will also evaluate the process of delivering TACTIC.

Conclusion

This study will assess TACTIC's (cost)effectiveness and provide insights for successful delivery in general practice.

Clinical trials registration

clinicaltrials.gov NCT05647980.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

求助全文

约1分钟内获得全文去求助

来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.