Reducing Overuse of Antibiotics at Discharge Home

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.

• ROAD Home Intervention (Other): Hospitals randomized to receive the ROAD Home Intervention will undergo (1) a baseline needs assessment to create a customized suite of stewardship strategies, (2) supported decision-making in selecting ROAD Home strategies to implement, and (3) external facilitation following an implementation blueprint.

Primary outcomes

• 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 outcomes

• 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.

Other outcomes

• Number of cases with composite 30-day outcome event [12 months; 30-days post hospital discharge]: Composite 30-day outcome of mortality, readmission, and need for additional care (i.e., urgent/emergent visit) collected via patient phone call and chart review 30-days after hospital discharge. The score is the number of cases with a composite 30-day outcome event.
• Number of cases with 30-day mortality [12 months; 30-days post hospital discharge]: The score is the number of cases with 30-day outcome mortality.
• Number of cases with 30-day readmission [12 months; 30-days post hospital discharge]: The score is the number of cases with 30-day readmission.
• Number of cases with 30-day C Difficile infection [12 months; 30-days post hospital discharge]: The score is the number of cases with 30-day C Difficile infection.

Sex: All, ages: 18 Years to any

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)

• Vaughn VM, Ratz D, Greene MT, Flanders SA, Gandhi TN, Petty LA, Huls S, Feng X, White AT, Hersh AL. Antibiotic Stewardship Strategies and Their Association With Antibiotic Overuse After Hospital Discharge: An Analysis of the Reducing Overuse of Antibiotics at Discharge (Road) Home Framework. Clin Infect Dis. 2022 Sep 29;75(6):1063-1072. doi: 10.1093/cid/ciac104. PMID 35143638
• Vaughn VM, Gandhi TN, Chopra V, Petty LA, Giesler DL, Malani AN, Bernstein SJ, Hsaiky LM, Pogue JM, Dumkow L, Ratz D, McLaughlin ES, Flanders SA. Antibiotic Overuse After Hospital Discharge: A Multi-hospital Cohort Study. Clin Infect Dis. 2021 Dec 6;73(11):e4499-e4506. doi: 10.1093/cid/ciaa1372. PMID 32918077
• Vaughn VM, Hersh AL, Spivak ES. Antibiotic Overuse and Stewardship at Hospital Discharge: The Reducing Overuse of Antibiotics at Discharge Home Framework. Clin Infect Dis. 2022 May 3;74(9):1696-1702. doi: 10.1093/cid/ciab842. PMID 34554249
• Results publication: Vaughn VM, Horowitz J, Gandhi T, Neetz RA, Petty L, Hersh A, Lindenauer P, Bernstein SJ, Flanders SA, Harrison JD, Smith JD, White AT, Szymczak JE. Developing an approach to enhance recruitment for a cluster-randomised implementation trial: leveraging deliberative participation and credible messengers. BMJ Open. 2025 Sep 16;15(9):e094925. doi: 10.1136/bmjopen-2024-094925. PMID 40962335
• Results publication: Szymczak JE, Petty LA, Gandhi TN, Neetz RA, Hersh A, Presson AP, Lindenauer PK, Bernstein SJ, Muller BM, White AT, Horowitz JK, Flanders SA, Smith JD, Vaughn VM. Protocol for a parallel cluster randomized trial of a participatory tailored approach to reduce overuse of antibiotics at hospital discharge: the ROAD home trial. Implement Sci. 2024 Mar 4;19(1):23. doi: 10.1186/s13012-024-01348-w. PMID 38439076

• Informed Consent Form (PDF, 2023-07-07)

• Valerie M Vaughn, MD, Principal investigator, University of Utah