Reducing Overuse of Antibiotics at Discharge Home

Not Applicable

• Conditions: Urinary Tract Infection; Pneumonia; Antibiotic Stewardship; Care Transition
• Interventions: Other: ROAD Home Intervention

• Registration Number: NCT06106204
• Lead Sponsor: University of Utah

Brief Summary

The goal of this two-arm parallel cluster-randomized trial of 40 hospitals is to test the effectiveness of the ROAD Home Intervention on days of antibiotic overuse at discharge in patients hospitalized with community-acquired pneumonia (CAP) or urinary tract infection (UTI). The main question it aims to answer is: Does an antibiotic stewardship approach that is customized to the needs, goals, and resources of a hospital (i.e., the ROAD Home Intervention) compared to standard stewardship approaches reduce antibiotic overuse at discharge in hospitalized patients with CAP and UTI? The investigators will randomize 20 hospitals in the Michigan Hospital Medicine Safety Consortium (HMS) to the intervention group and 20 HMS hospitals to the "usual care" control group. During the study the investigators will: (a) assess baseline performance, existing stewardship strategies, hospital priorities, and resources; (b) develop a customized discharge stewardship "suite" for each intervention hospital based on the findings of the baseline assessment and informed by the ROAD Home Framework; and (c) support hospitals in selecting strategies and creating an implementation blueprint to be implemented over 12 to 15 months. After the intervention period, the investigators will compare days of antibiotic overuse at discharge and patient outcomes between intervention and "usual care" hospitals. It is hypothesized that hospitals randomized to the ROAD Home Intervention will have fewer days of antibiotic overuse at discharge compared to "stewardship as usual" control hospitals.

Detailed Description

The Reducing Overuse of Antibiotics at Discharge (ROAD) Home study is designed to test the hypothesis that hospitals randomized to an implementation intervention that includes external facilitation to support participants while allowing for free choice in selecting and implementing evidence-based antibiotic stewardship strategies based on local context will have fewer days of antibiotic overuse at discharge than "stewardship as usual" control hospitals. The first aim of this study is to evaluate the effectiveness of the ROAD Home Intervention on days of antibiotic overuse at discharge for hospitalized patients treated for CAP and UTI. The second aim of this study is to identify contextual factors influencing the implementation of the ROAD Home Intervention and to assess implementation outcomes (acceptability, feasibility, fidelity, and sustainment) to inform future broad dissemination.

A two-arm, parallel, cluster-randomized trial will assess the effect of the ROAD Home Intervention on days of antibiotic overuse at discharge. Forty hospitals will be recruited from the Michigan Hospital Medicine Safety Consortium (HMS; https://mi-hms.org/), a statewide 69-hospital collaborative consisting of diverse hospitals and focused on improving the care of hospitalized patients. HMS hospitals that agree to participate will undergo covariate-constrained randomization to improve balancing of critical hospital characteristics between groups with 1:1 allocation to the ROAD Home intervention vs. a "stewardship as usual" control. In the 12- to 15-month intervention period, hospitals will implement the intervention while investigators assess days of antibiotic overuse at discharge and patient outcomes. During the intervention period and in the 9-month post-intervention period, investigators will conduct a theory-informed mixed-methods process evaluation to evaluate barriers, facilitators, and implementation outcomes across hospitals.

Study Timeline

• Study First Submitted: 2023-10-07
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-30
• Study Start: 2023-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2025-01-01
• Primary Completion: 2027-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

All Patients:

• Adult patient admitted and discharged from the participating hospital and included in HMS registry
• Admitted to a general care medicine service
• Received any eligible antibiotic during the symptom collection window (-1 to +2 days for UTI; day 1 or 2 for pneumonia)
• Immunocompetent (allowing for mild immune suppression)
• Do not have a concomitant infection (e.g., antibiotic treatment for unrelated infection or prophylaxis)

Specific inclusion criteria for patients with UTI:

• Positive urine culture
• Have normal urinary anatomy

Specific inclusion criteria for patients with pneumonia:

• Discharge diagnosis of pneumonia

Exclusion Criteria

All Patients:

• Left against medical advice or refused medical care
• Admitted on hospice
• Pregnant
• Unable to determine actual or expected antibiotic duration

Specific exclusions for patients with UTI:

• spinal cord injury

Specific exclusions for patients with pneumonia:

• Cystic fibrosis
• Pneumonia-related complication (e.g., empyema)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ROAD Home Intervention	ROAD Home Intervention	Hospitals randomized to receive the ROAD Home Intervention will receive an implementation intervention that includes external facilitation to support them in selecting and implementing evidence-based antibiotic stewardship strategies based on local context and the ROAD Home framework (https://academic.oup.com/cid/article/74/9/1696/6374407).

Primary Outcome Measures

Name	Time	Method
Days of antibiotic overuse at hospital discharge	12 months; from discharge prescription	Antibiotic overuse at discharge is a composite score of unnecessary antibiotic use, excessive antibiotic duration, and avoidable fluoroquinolones. The score is number of days of antibiotic overuse at hospital discharge.

Secondary Outcome Measures

Name	Time	Method
Number of cases with antibiotic-associated adverse events	12 months; 30-days post hospital discharge	This is a composite metric that includes patient-reported and physician-reported adverse events that are abstracted through chart review (routinely performed as part of being part of the HMS collaborative) as well as Clostridioides difficile laboratory events. The score is the number of cases who had antibiotic-associated adverse-events.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States