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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05172791
• Other study ID #: 2021p002282
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 11, 2022
• Est. completion date: February 15, 2024

Study information

• Verified date: August 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: February 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pneumonia

Intervention

Behavioral:
• Antibiotic stewardship messaging
Counseling regarding antibiotics for patients prescribed antibiotics for possible pneumonia despite respiratory rates and oxygenation levels within normal ranges

Locations

Country	Name	City	State
United States	Brigham and Womens Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Antibiotic-free days in the 30-days post-randomization	Antibiotic-free days in the 30-days post-randomization	30-days post-randomization
Secondary	Days from randomization to discharge	Days from randomization to discharge	Duration of hospitalization, up to 90 days
Secondary	Hospital length of stay	Hospital length of stay	Duration of hospitalization, up to 90 days
Secondary	In-hospital mortality	In-hospital mortality	During initial hospitalization with pneumonia, up to 90 days
Secondary	Readmissions within 30-days of randomization	Readmissions within 30-days of randomization	30-days post-randomization
Secondary	Hospital-free days in the 30-days post-randomization	Hospital-free days in the 30-days post-randomization	30-days post-randomization
Secondary	C. difficile infections in the 30-days post-randomization	C. difficile infections in the 30-days post-randomization	30-days post-randomization
Secondary	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