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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05172791
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
2,000
1
3
19.2
104.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Antibiotic stewardship messaging
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Decreasing Unnecessary Antibiotics Prescribed for Possible Pneumonia Despite Normal Respiratory Rate and Oxygenation
Actual Study Start Date :
Jul 11, 2022
Anticipated Primary Completion Date :
Jan 15, 2024
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Antibiotic-free days in the 30-days post-randomization [30-days post-randomization]

    Antibiotic-free days in the 30-days post-randomization

  2. Days from randomization to discharge [Duration of hospitalization, up to 90 days]

    Days from randomization to discharge

  3. Hospital length of stay [Duration of hospitalization, up to 90 days]

    Hospital length of stay

  4. In-hospital mortality [During initial hospitalization with pneumonia, up to 90 days]

    In-hospital mortality

  5. Readmissions within 30-days of randomization [30-days post-randomization]

    Readmissions within 30-days of randomization

  6. Hospital-free days in the 30-days post-randomization [30-days post-randomization]

    Hospital-free days in the 30-days post-randomization

  7. C. difficile infections in the 30-days post-randomization [30-days post-randomization]

    C. difficile infections in the 30-days post-randomization

  8. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Womens Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Brigham and Women's Hospital
  • Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Michael Klompas, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Klompas, M.D., Medical Doctor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT05172791
Other Study ID Numbers:
  • 2021p002282
First Posted:
Dec 29, 2021
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Michael Klompas, M.D., Medical Doctor, Brigham and Women's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2022