Protocol for a parallel cluster randomized trial of a participatory tailored approach to reduce overuse of antibiotics at hospital discharge: the ROAD home trial

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: Clinicaltrials.gov NCT06106204 on 10/30/23.

Keywords: Antibiotic stewardship; Facilitation; Hospital discharge; Integrated Promoting Action on Research Implementation in Health Services Research (i-PARIHS) framework; Pneumonia; Tailoring; Transitions of care; Urinary tract infection.

Fig. 1

CONSORT diagram. HMS, Michigan Hospital Medicine Safety Consortium; MMI, methods motivational interviewing. ^aHospitals will undergo covariate-constrained randomization to improve balancing of critical characteristics between groups with 1:1 allocation

Fig. 2

SPIRIT flow diagram: schedule of enrollment, interventions, and assessments

Fig. 3

ROAD Home Trial Implementation Research Logic Model. CFIR, Consolidated Framework for Implementation Research, Damschroder et al. Implementation Science (2022). ERIC, Expert Recommendations for Implementing Change, Powell et al. Implementation Science (2015). HMS, Michigan Hospital Medicine Safety Consortium. Implementation Research Logic Model Template from Smith et al. Implementation Science (2020). Color coding indicates the connection between the ERIC strategy and mechanism proposed for how it impacts implementation outcomes (underlined). +  = facilitator.—= barrier

Fig. 4

ROAD Home strategy. HMS, Michigan Hospital Medicine Safety Consortium

Fig. 5

Example tailored ROAD Home suite