Department of Internal Medicine, Division of Epidemiology, University of Utah School of Medicine, 295 Chipeta Way, Salt Lake City, UT, 84132, USA.
Department of Internal Medicine, Division of Infectious Diseases, Michigan Medicine, University of Michigan, Ann Arbor, MI, USA.
Implement Sci. 2024 Mar 4;19(1):23. doi: 10.1186/s13012-024-01348-w.
Antibiotic overuse at hospital discharge is common, costly, and harmful. While discharge-specific antibiotic stewardship interventions are effective, they are resource-intensive and often infeasible for hospitals with resource constraints. This weakness impacts generalizability of stewardship interventions and has health equity implications as not all patients have access to the benefits of stewardship based on where they receive care. There may be different pathways to improve discharge antibiotic prescribing that vary widely in feasibility. Supporting hospitals in selecting interventions tailored to their context may be an effective approach to feasibly reduce antibiotic overuse at discharge across diverse hospitals. The objective of this study is to evaluate the effectiveness of the Reducing Overuse of Antibiotics at Discharge Home multicomponent implementation strategy ("ROAD Home") on antibiotic overuse at discharge for community-acquired pneumonia and urinary tract infection.
This 4-year two-arm parallel cluster-randomized trial will include three phases: baseline (23 months), intervention (12 months), and postintervention (12 months). Forty hospitals recruited from the Michigan Hospital Medicine Safety Consortium will undergo covariate-constrained randomization with half randomized to the ROAD Home implementation strategy and half to a "stewardship as usual" control. ROAD Home is informed by the integrated-Promoting Action on Research Implementation in Health Services Framework and includes (1) a baseline needs assessment to create a tailored suite of potential stewardship interventions, (2) supported decision-making in selecting interventions to implement, and (3) external facilitation following an implementation blueprint. The primary outcome is baseline-adjusted days of antibiotic overuse at discharge. Secondary outcomes include 30-day patient outcomes and antibiotic-associated adverse events. A mixed-methods concurrent process evaluation will identify contextual factors influencing the implementation of tailored interventions, and assess implementation outcomes including acceptability, feasibility, fidelity, and sustainment.
Reducing antibiotic overuse at discharge across hospitals with varied resources requires tailoring of interventions. This trial will assess whether a multicomponent implementation strategy that supports hospitals in selecting evidence-based stewardship interventions tailored to local context leads to reduced overuse of antibiotics at discharge. Knowledge gained during this study could inform future efforts to implement stewardship in diverse hospitals and promote equity in access to the benefits of quality improvement initiatives.
Clinicaltrials.gov NCT06106204 on 10/30/23.
医院出院时抗生素过度使用很常见，代价高昂且有害。尽管针对出院患者的具体抗生素管理干预措施有效，但这些措施需要大量资源，且对于资源有限的医院往往不可行。这种局限性影响了管理干预措施的推广，也对健康公平产生了影响，因为并非所有患者都能根据其就诊医院的不同而获得管理带来的益处。改善出院时抗生素处方的途径可能有很多，其可行性差异很大。支持医院根据自身情况选择干预措施可能是一种有效的方法，可切实减少不同医院出院时抗生素的过度使用。本研究旨在评估减少出院时抗生素过度使用的综合实施策略（“ROAD Home”）在社区获得性肺炎和尿路感染出院时抗生素过度使用方面的有效性。
这是一项为期 4 年的、采用两臂平行聚类随机试验，将包括三个阶段：基线（23 个月）、干预（12 个月）和干预后（12 个月）。密歇根医院医学安全联盟招募的 40 家医院将进行协变量约束随机分组，其中一半随机分配到 ROAD Home 实施策略组，另一半随机分配到“常规管理”对照组。ROAD Home 以综合促进卫生服务实施研究行动框架为指导，包括（1）基线需求评估，以制定一套潜在管理干预措施；（2）支持在选择要实施的干预措施时进行决策；（3）根据实施蓝图提供外部促进。主要结局是调整基线后的出院时抗生素过度使用天数。次要结局包括 30 天患者结局和抗生素相关不良事件。混合方法同期进程评估将确定影响定制干预措施实施的背景因素，并评估包括可接受性、可行性、忠实度和可持续性在内的实施结果。
在资源差异较大的医院中减少出院时抗生素过度使用需要定制干预措施。本试验将评估支持医院根据当地情况选择基于证据的管理干预措施的综合实施策略是否可减少出院时抗生素的过度使用。本研究期间获得的知识可用于未来在不同医院实施管理以及促进获得质量改进举措益处方面的公平性。
Clinicaltrials.gov NCT06106204，于 2023 年 10 月 30 日注册。
