Pneumonia
Conditions
Keywords
antibiotic stewardship, pneumonia
Brief summary
The purpose of this study is to decrease unnecessary antibiotics prescribed to hospitalized patients for possible pneumonia by flagging patients with respiratory rates and oxygenation levels within reference ranges given prior data suggesting that discontinuing antibiotics in this population is safe. Patients will be randomized to 3 arms: 1) usual care, 2) electronic alert, or 3) pharmacist outreach.
Detailed description
Prior data suggest antibiotic starts for patients with normal vital signs are common and there does not appear to be harm associated with stopping antibiotics after only 1 or 2 days in patients with normal oxygen saturations. We therefore propose a pilot patient-level three-way randomized trial to determine the best way to operationalize professional society recommendations for post-prescription antibiotic reviews amongst patients started on antibiotics with a stated indication of pneumonia despite normal respiratory rates and oxygenation levels. If the patient's median respiratory rate and oxygen saturation is normal after 1-2 days of antibiotics they will be randomized to usual care versus a EHR-based best practice alert versus pharmacist outreach. The EHR-based best practice alert will highlight the patient's normal respiratory rate and oxygenation and encourage stopping antibiotics if there isn't another indication for antibiotics. Pharmacist outreach will involve contacting the responding clinician or attending physician to determine the working diagnosis, review the patient's vital signs, and to ask the team to consider stopping antibiotics if there are no clear indications for antibiotics. In all cases, the final decision on whether to stop or continue antibiotics will be up to the primary team. We will assess the impact of these post-prescription review strategies to decrease unnecessary antibiotic utilization on antibiotic utilization (antibiotic days and antibiotic-free days) compared to usual care. Safety outcomes will include time to discharge, readmissions, hospital-free days, and mortality. We will also assess for change in the primary outcome over time.
Interventions
BEHAVIORALAntibiotic stewardship messaging
Counseling regarding antibiotics for patients prescribed antibiotics for possible pneumonia despite respiratory rates and oxygenation levels within normal ranges
Sponsors
Centers for Disease Control and Prevention
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients admitted to Brigham and Women's and BWH Faulkner Hospitals and prescribed antibiotics with a stated indication of pneumonia who have a median respiratory rate of ≤20 and oxygen saturation of ≥95% without supplemental oxygen sustained for at least 24 hours.
Exclusion criteria
* Patients under 18 years old, patients on transplant and oncology services, patients who are pregnant, patients in an intensive care unit, patients with cystic fibrosis or bronchiectasis, patients on immunosuppressive medications, and patients with positive blood cultures (other than common skin contaminants)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of antibiotics prescribed for pneumonia | Number of days of antibiotics given during hospitalization plus number of days of antibiotics for pneumonia on discharge prescriptions, up to 30 days | Duration of antibiotics prescribed for pneumonia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days from randomization to discharge | Duration of hospitalization, up to 90 days | Days from randomization to discharge |
| Hospital length of stay | Duration of hospitalization, up to 90 days | Hospital length of stay |
| In-hospital mortality | During initial hospitalization with pneumonia, up to 90 days | In-hospital mortality |
| Antibiotic-free days in the 30-days post-randomization | 30-days post-randomization | Antibiotic-free days in the 30-days post-randomization |
| Hospital-free days in the 30-days post-randomization | 30-days post-randomization | Hospital-free days in the 30-days post-randomization |
| C. difficile infections in the 30-days post-randomization | 30-days post-randomization | C. difficile infections in the 30-days post-randomization |
| Acute kidney injury (maximum creatinine in the 14-days post-randomization) | 14 days post-randomization | Acute kidney injury (maximum creatinine in the 14-days post-randomization) |
| Readmissions within 30-days of randomization | 30-days post-randomization | Readmissions within 30-days of randomization |
Countries
United States
Outcome results
None listed