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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pneumonia
• Intervention / Treatment: Behavioral: Antibiotic stewardship messaging

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.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Clinical teams will decide on antibiotic duration for patients with possible pneumonia without external prompting
Experimental: Electronic alert; 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; Counseling regarding antibiotics for patients prescribed antibiotics for possible pneumonia despite respiratory rates and oxygenation levels within normal ranges
Experimental: Pharmacist; 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; Counseling regarding antibiotics for patients prescribed antibiotics for possible pneumonia despite respiratory rates and oxygenation levels within normal ranges

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Michael Klompas, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Estimated): January 15, 2024
• Study Completion (Estimated): February 15, 2024

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 11, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: antibiotic stewardship; pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2021p002282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No