Decreasing Unnecessary Antibiotics Prescribed for Possible Pneumonia Despite Normal Respiratory Rate and Oxygenation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Decreasing Unnecessary Antibiotics Prescribed for Possible Pneumonia Despite Normal Respiratory Rate and Oxygenation

Conditions
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Pneumonia

Intervention / Treatment
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* Behavioral: Antibiotic stewardship messaging


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Clinical teams will decide on antibiotic duration for patients with possible pneumonia without external prompting | |
| Experimental: Electronic alert<br>An electronic alert will be displayed within the electronic medical record of eligible patients that notes that the patient's respiratory rate and oxygenation are within the normal range and will advise stopping antibiotics prescribed for possible pneumonia | Behavioral: Antibiotic stewardship messaging<br>* Counseling regarding antibiotics for patients prescribed antibiotics for possible pneumonia despite respiratory rates and oxygenation levels within normal ranges<br>|
| Experimental: Pharmacist<br>Pharmacists will contact the treating teams of eligible patients to note that the patient's respiratory rate and oxygenation are within the normal range and will advise stopping antibiotics prescribed for possible pneumonia. | Behavioral: Antibiotic stewardship messaging<br>* Counseling regarding antibiotics for patients prescribed antibiotics for possible pneumonia despite respiratory rates and oxygenation levels within normal ranges<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of antibiotics prescribed for pneumonia | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic-free days in the 30-days post-randomization | Antibiotic-free days in the 30-days post-randomization | 30-days post-randomization | 
| Days from randomization to discharge | Days from randomization to discharge | Duration of hospitalization, up to 90 days | 
| Hospital length of stay | Hospital length of stay | Duration of hospitalization, up to 90 days | 
| In-hospital mortality | In-hospital mortality | During initial hospitalization with pneumonia, up to 90 days | 
| Readmissions within 30-days of randomization | Readmissions within 30-days of randomization | 30-days post-randomization | 
| Hospital-free days in the 30-days post-randomization | Hospital-free days in the 30-days post-randomization | 30-days post-randomization | 
| C. difficile infections in the 30-days post-randomization | C. difficile infections in the 30-days post-randomization | 30-days post-randomization | 
| Acute kidney injury (maximum creatinine in the 14-days post-randomization) | Acute kidney injury (maximum creatinine in the 14-days post-randomization) | 14 days post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibiotic stewardship, pneumonia