基层医疗中使用抗精神病药物患者心血管风险管理与用药评估的跨壁协作护理模式（TACTIC）：一项不完全阶梯楔形整群随机试验的研究方案

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.

作者信息

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

机构信息

Radboud University Medical Center, Primary and Community Care Department Nijmegen, the Netherlands.

Zorggroep Onze Huisartsen B.V., Arnhem, the Netherlands.

出版信息

Contemp Clin Trials Commun. 2025 Jan 9;44:101418. doi: 10.1016/j.conctc.2024.101418. eCollection 2025 Apr.

DOI:10.1016/j.conctc.2024.101418

PMID:39897941

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11787019/

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.

摘要

背景

重度精神疾病患者以及接受非典型抗精神病药物（AAPs）治疗的患者患心血管疾病的风险增加，这一点已得到充分证实。然而，目前基层医疗对AAPs的使用、其效果以及相关心血管风险缺乏充分监测。我们开发了TACTIC，这是一种针对使用全科医生（GP）开具的AAPs的患者的跨学科协作护理模式，以解决AAPs潜在过度治疗和心血管风险治疗不足的问题。TACTIC包括三个步骤：为患者提供信息视频、多学科会议以及与全科医生进行共同决策咨询。

目的

评估TACTIC对心血管风险和心理健康的有效性及其成本效益。

方法

我们将在荷兰进行一项不完全阶梯式楔形整群随机试验。40个全科医生 - 护士群组被随机分为四组。每个群组招募成年患者（25 - 85岁），这些患者之前未被诊断患有痴呆、谵妄或心血管疾病，且全科医生为其开具了AAPs。每五个月，一组新的患者开始接受TACTIC治疗。在干预开始前以及直至研究结束每五个月进行一次测量。主要结局分别用QRISK3评分和MHI5量表测量心血管风险和心理健康状况。经济评估包括两项成本效用分析，一项基于试验期间收集的数据，另一项基于将试验数据外推至10年的模型。我们还将评估实施TACTIC的过程。