Reducing Overuse of Antibiotics at Discharge Home
Enrolling by invitation · Not applicable
Conditions studied: Pneumonia, Urinary Tract Infection, Antibiotic Stewardship, Care Transition
In brief
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.
Key facts
- Study ID
- NCT06106204
- Run by
- University of Utah
- People needed
- 40
- Starts
- 2023-11-01
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2026-01-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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