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Effect of BPA on Anchor Antibiotic Continuity in the ED: Randomized Controlled Trial

Primary Purpose

Infections, Bacterial, Sepsis, Alert Fatigue, Health Personnel

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epic Best Practice Alert
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections, Bacterial focused on measuring Antibiotics, Electronic alert

Eligibility Criteria

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

Inclusion Criteria:

  • All adult patients (>= 18 years old) who are seen in a Mass General Brigham Emergency Department who had a specific anchor antibiotic administered

Exclusion Criteria:

  • None

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active Best Practice Alert

Inactive Best Practice Alert

Arm Description

Care providers taking care of these patients will receive a Best Practice Alert (BPA) in the electronic medical record (EMR) one hour before an antibiotic expires with no subsequent doses ordered. The BPA will prompt the care provider to re-order the antibiotic and give information on recommended dosage and frequency based on indication and patient characteristics.

The Best Practice Alert described in the Experimental Arm will not be active for patients in this arm. Care providers will proceed with usual care.

Outcomes

Primary Outcome Measures

Delay Time to Next Antibiotic Dose
The length of delay between time of expected antibiotic re-administration and the actual time of antibiotic re-administration

Secondary Outcome Measures

Hospital Length-of-stay
Number of days that patient is hospitalized
Admission to Intensive Care Unit (ICU)
Whether a patient received care in the Intensive Care Unit (ICU) during hospital admission
In-hospital mortality
Whether a patient received died during hospital admission

Full Information

First Posted
October 27, 2020
Last Updated
August 17, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04620486
Brief Title
Effect of BPA on Anchor Antibiotic Continuity in the ED: Randomized Controlled Trial
Official Title
Effect of BPA on Anchor Antibiotic Continuity in the ED: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective is to compare the timeliness of anchor antibiotic administration in the emergency department (ED) after initial dosing with and without a Best Practice Alert in Epic (BPA) implemented to remind physicians to re-order the antibiotic. We hypothesize that post-BPA implementation, physicians will have a higher rate of ordering subsequent doses of antibiotics on-time and with the correct dosages compared to pre-BPA implementation.
Detailed Description
Antibiotics administration can sometimes be delayed in the emergency department (ED) environment, where antibiotics are frequently ordered in electronic medical record systems as a one-time dose and the second dose is delayed or missed. This has been described in the literature, a 2017 article in Critical Care Medicine noted in a single academic center that 33% of sepsis cases had 2nd-dose-antibiotic delays greater than 25% of the recommend interval and this was associated with significantly increased hospital mortality (OR 1.61) and mechanical ventilation (OR 2.44). An Epic Best Practice Advisory (BPA) was created by the Mass General Brigham eCare Decision Support team to address this patient safety concern. The BPA alerts providers in the ED or ED Observation when the next dose of broad-spectrum antibiotic dose is due for a patient if no future administration has been ordered, based on patient characteristics (such as renal function) and antibiotic selection. The objective of this study is to analyze the impact of this BPA on our performance in terms of on-time antibiotics through a randomized controlled trial. Patients whose medical record number (MRN) are odd will be assigned to the treatment group, while those whose MRNs are even will be assigned to the control group. The BPA will only be displayed to the patient's providers for the treatment group. We will then compare the performance of on-time antibiotics between the groups and the resulting impact on patient outcomes, such as overall hospital length of stay, admission to the intensive care unit (ICU), and in-hospital mortality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Bacterial, Sepsis, Alert Fatigue, Health Personnel
Keywords
Antibiotics, Electronic alert

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients whose medical record numbers (MRN) are odd will be assigned to the treatment group, while those whose MRNs are even will be assigned to the control group. The intervention, which is the Best Practice Alert in Epic, will only be displayed to the patient's care providers for the treatment group.
Masking
Participant
Masking Description
Patients will be masked to which group they are assigned. Care Providers will not be masked as they will be shown a Best Practice Alert (BPA) only for patients in the treatment arm. The investigators will not be masked.
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Best Practice Alert
Arm Type
Experimental
Arm Description
Care providers taking care of these patients will receive a Best Practice Alert (BPA) in the electronic medical record (EMR) one hour before an antibiotic expires with no subsequent doses ordered. The BPA will prompt the care provider to re-order the antibiotic and give information on recommended dosage and frequency based on indication and patient characteristics.
Arm Title
Inactive Best Practice Alert
Arm Type
No Intervention
Arm Description
The Best Practice Alert described in the Experimental Arm will not be active for patients in this arm. Care providers will proceed with usual care.
Intervention Type
Other
Intervention Name(s)
Epic Best Practice Alert
Intervention Description
This is a customized Best Practice Alert created at Mass General Brigham in the institutional Epic electronic medical record system.
Primary Outcome Measure Information:
Title
Delay Time to Next Antibiotic Dose
Description
The length of delay between time of expected antibiotic re-administration and the actual time of antibiotic re-administration
Time Frame
Between 0 and 24 hours after expected antibiotic re-administration
Secondary Outcome Measure Information:
Title
Hospital Length-of-stay
Description
Number of days that patient is hospitalized
Time Frame
Through study completion, up to 1 year
Title
Admission to Intensive Care Unit (ICU)
Description
Whether a patient received care in the Intensive Care Unit (ICU) during hospital admission
Time Frame
Through study completion, up to 1 year
Title
In-hospital mortality
Description
Whether a patient received died during hospital admission
Time Frame
Through study completion, up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All adult patients (>= 18 years old) who are seen in a Mass General Brigham Emergency Department who had a specific anchor antibiotic administered Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayon Dutta, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Given HIPAA concerns and lack of scientific need, we do not plan on sharing individual participant data (IPD).

Learn more about this trial

Effect of BPA on Anchor Antibiotic Continuity in the ED: Randomized Controlled Trial

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