Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT05172791
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Counseling regarding antibiotics for patients prescribed antibiotics for possible pneumonia despite respiratory rates and oxygenation levels within normal ranges
Time frame: 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
Time frame: 30-days post-randomization
Antibiotic-free days in the 30-days post-randomization
Time frame: Duration of hospitalization, up to 90 days
Days from randomization to discharge
Time frame: Duration of hospitalization, up to 90 days
Hospital length of stay
Time frame: During initial hospitalization with pneumonia, up to 90 days
In-hospital mortality
Time frame: 30-days post-randomization
Readmissions within 30-days of randomization
Time frame: 30-days post-randomization
Hospital-free days in the 30-days post-randomization
Time frame: 30-days post-randomization
C. difficile infections in the 30-days post-randomization
Time frame: 14 days post-randomization
Acute kidney injury (maximum creatinine in the 14-days post-randomization)
Brigham and Women's Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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