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Reducing Overuse of Antibiotics at Discharge Home

A Parallel Cluster Randomized Trial of a Participatory Approach to Reduce Overuse of Antibiotics at Hospital Discharge: The ROAD Home Trial

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06106204
Acronym
ROAD Home
Enrollment
40
Registered
2023-10-30
Start date
2023-11-01
Completion date
2028-08-31
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Stewardship, Care Transition, Pneumonia, Urinary Tract Infection

Keywords

Antibiotic Stewardship, Hospital Discharge, Urinary Tract Infection, Pneumonia, Facilitation, Adaptation, i-PARIHS Framework, Implementation Research Logic Model

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.

Interventions

OTHERROAD Home Intervention

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.

Sponsors

University of Michigan
CollaboratorOTHER
University of Utah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Two-arm, parallel, cluster-randomized trial of 40 hospitals randomized to an implementation intervention designed to support antibiotic stewardship interventions vs. usual care control.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Days of antibiotic overuse at hospital discharge12 months; from discharge prescriptionAntibiotic 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

MeasureTime frameDescription
Number of cases with antibiotic-associated adverse events12 months; 30-days post hospital dischargeThis 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

MeasureTime frameDescription
Number of cases with composite 30-day outcome event12 months; 30-days post hospital dischargeComposite 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 mortality12 months; 30-days post hospital dischargeThe score is the number of cases with 30-day outcome mortality.
Number of cases with 30-day readmission12 months; 30-days post hospital dischargeThe score is the number of cases with 30-day readmission.
Number of cases with 30-day C Difficile infection12 months; 30-days post hospital dischargeThe score is the number of cases with 30-day C Difficile infection.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026