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. 2025 Jan 9:44:101418.
doi: 10.1016/j.conctc.2024.101418. eCollection 2025 Apr.

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

Kirsti M Jakobs  1   2 , Karlijn J van den Brule-Barnhoorn  1 , Jan van Lieshout  3 , Joost G E Janzing  4 , Wiepke Cahn  5   6 , Wietske Kievit  3 , Steven Teerenstra  7 , Maria van den Muijsenbergh  1 , Marion C J Biermans  1 , Erik W M A Bischoff  1
Affiliations

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

Kirsti M Jakobs et al. Contemp Clin Trials Commun. .

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.

Keywords: Antipsychotics; Cardiovascular risk; Collaborative care; Deprescribing; Off label; Primary health care.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
The TACTIC intervention consists of an informative video for patients, a multidisciplinary meeting, and a shared decision visit.
Fig. 2
Fig. 2
TACTIC study diagram. ∗The prescriptions from the ATC codes [22]. The ATC codes are similar to those in the QRISK3 algorithm as far as they are registered in the Netherlands: N05AX12, N05AD06, N05AH02, N05AE05, N05AH03, N05AX13, N05AH04, N05AX08, N05AE03, N05AX15, N05AX16 ∗∗The diagnoses from the ICPC codes [23]. Abbreviations: AAP, atypical antipsychotic; AP, antipsychotic; ATC, anatomical therapeutic chemical; CVD, cardiovascular disease; CVRM, cardiovascular risk management; CVD, cardiovascular disorder; EMR, electronic medical records; GP, general practitioner; HDL, high-density lipoprotein; ICPC, International Classification of Primary Care; i-SWCRT, incomplete stepped wedge cluster randomized trial; QRISK3, a tool to calculate the estimated CVD risk within the next 10 years for people aged between 25 and 84 without CVD.
Fig. A1
Fig. A1
The structure of the multidisciplinary meeting.
See this image and copyright information in PMC

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