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

Primary Purpose

Pneumonia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Antibiotic stewardship messaging
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring antibiotic stewardship, pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Brigham and Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Usual care

Electronic alert

Pharmacist

Arm Description

Clinical teams will decide on antibiotic duration for patients with possible pneumonia without external prompting

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

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.

Outcomes

Primary Outcome Measures

Duration of antibiotics prescribed for pneumonia
Duration of antibiotics prescribed for pneumonia

Secondary Outcome Measures

Antibiotic-free days in the 30-days post-randomization
Antibiotic-free days in the 30-days post-randomization
Days from randomization to discharge
Days from randomization to discharge
Hospital length of stay
Hospital length of stay
In-hospital mortality
In-hospital mortality
Readmissions within 30-days of randomization
Readmissions within 30-days of randomization
Hospital-free days in the 30-days post-randomization
Hospital-free days in the 30-days post-randomization
C. difficile infections in the 30-days post-randomization
C. difficile infections in the 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)

Full Information

First Posted
December 1, 2021
Last Updated
August 23, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05172791
Brief Title
Decreasing Unnecessary Antibiotics Prescribed for Possible Pneumonia Despite Normal Respiratory Rate and Oxygenation
Official Title
Decreasing Unnecessary Antibiotics Prescribed for Possible Pneumonia Despite Normal Respiratory Rate and Oxygenation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Centers for Disease Control and Prevention

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
antibiotic stewardship, pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Clinical teams will decide on antibiotic duration for patients with possible pneumonia without external prompting
Arm Title
Electronic alert
Arm Type
Experimental
Arm Description
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
Arm Title
Pharmacist
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Antibiotic stewardship messaging
Intervention Description
Counseling regarding antibiotics for patients prescribed antibiotics for possible pneumonia despite respiratory rates and oxygenation levels within normal ranges
Primary Outcome Measure Information:
Title
Duration of antibiotics prescribed for pneumonia
Description
Duration of antibiotics prescribed for pneumonia
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
Secondary Outcome Measure Information:
Title
Antibiotic-free days in the 30-days post-randomization
Description
Antibiotic-free days in the 30-days post-randomization
Time Frame
30-days post-randomization
Title
Days from randomization to discharge
Description
Days from randomization to discharge
Time Frame
Duration of hospitalization, up to 90 days
Title
Hospital length of stay
Description
Hospital length of stay
Time Frame
Duration of hospitalization, up to 90 days
Title
In-hospital mortality
Description
In-hospital mortality
Time Frame
During initial hospitalization with pneumonia, up to 90 days
Title
Readmissions within 30-days of randomization
Description
Readmissions within 30-days of randomization
Time Frame
30-days post-randomization
Title
Hospital-free days in the 30-days post-randomization
Description
Hospital-free days in the 30-days post-randomization
Time Frame
30-days post-randomization
Title
C. difficile infections in the 30-days post-randomization
Description
C. difficile infections in the 30-days post-randomization
Time Frame
30-days post-randomization
Title
Acute kidney injury (maximum creatinine in the 14-days post-randomization)
Description
Acute kidney injury (maximum creatinine in the 14-days post-randomization)
Time Frame
14 days post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Klompas, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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