Effectiveness of a Pharmacist-Led Intervention to Reduce Acid Suppression Therapy for Stress Ulcer Prophylaxis in ICUs in China: A Multicenter, Stepped-Wedge, Cluster-Randomized Controlled Trial

药师主导干预降低重症监护病房应激性溃疡预防中抑酸治疗效果的研究:一项多中心、阶梯楔形、整群随机对照试验

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Abstract

OBJECTIVES: This study aimed to evaluate the effectiveness of a pharmacist-led intervention in decreasing the overuse of stress ulcer prophylaxis (SUP) compared with the usual care for adult patients in Chinese ICUs. DESIGN: Pragmatic, multicenter, stepped-wedge, cluster-randomized controlled trial. SETTING: Twenty-six ICUs in China from October 2022 to March 2023. PATIENTS: We enrolled 2199 patients 18 years old or older who were newly admitted to the participating ICUs. INTERVENTIONS: Using the Medical Research Council framework for developing and evaluating complex intervention measures, a multidisciplinary team (Scenarios, Improving and Refining Interventions, Constructing, Refining and Testing Research Theories, Incorporating Stakeholders, Identifying Important Uncertainties, and Economics Considerations) designed a multifaceted intervention. MEASUREMENTS AND MAIN RESULTS: The primary outcomes were the proportion of patients receiving SUP and that with overt gastrointestinal bleeding. We conducted intention-to-treat analyses using generalized linear mixed models to adjust for potential confounders (age, sex, and acute physiology and chronic health evaluation II score) with random effects for the site. The proportion of patients receiving SUP in the intervention group was lower than that in the control group (45.5% vs. 49.5%; odds ratio [OR], 0.81; 95% CI, 0.68-0.96; p = 0.017). The proportion of patients with overt gastrointestinal bleeding was similar (3.7% vs. 4.0%; OR, 1.05; 95% CI, 0.65-2.85; p = 0.81). CONCLUSIONS: The pharmacist-led intervention reduced the proportion of patients receiving SUP in the ICUs, without significantly affecting the proportion of patients with overt gastrointestinal bleeding. These findings will help guide ICU medical decision-making.

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