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

NCT04620486 | Completed DMC

• 1 other identifier: 2020P001996
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections, Bacterial; Sepsis; Alert Fatigue, Health Personnel

Keywords

Antibiotics; Electronic alert

Outcome Measures

Primary Outcomes (1)

• 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

  Between 0 and 24 hours after expected antibiotic re-administration

Secondary Outcomes (3)

• Hospital Length-of-stay

  Through study completion, up to 1 year

• Admission to Intensive Care Unit (ICU)

  Through study completion, up to 1 year

• In-hospital mortality

  Through study completion, up to 1 year

Study Arms (2)

Active Best Practice Alert

EXPERIMENTAL

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.

Other: Epic Best Practice Alert

Inactive Best Practice Alert

NO INTERVENTION

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.

Interventions

Epic Best Practice Alert OTHER

This is a customized Best Practice Alert created at Mass General Brigham in the institutional Epic electronic medical record system.

Active Best Practice Alert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Lee AH, McEvoy DS, Stump T, Stevens R, Deng H, Rubins D, Filbin M, Hayes BD, Rhee C, Dutta S. Implementation of an Electronic Alert to Improve Timeliness of Second Dose Antibiotics for Patients With Suspected Serious Infections in the Emergency Department: A Quasi-Randomized Controlled Trial. Ann Emerg Med. 2023 Apr;81(4):485-491. doi: 10.1016/j.annemergmed.2022.10.022. Epub 2023 Jan 18.

  PMID: 36669909 DERIVED

MeSH Terms

Conditions

Bacterial Infections; Sepsis; Alert Fatigue, Health Personnel

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Fatigue; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Sayon Dutta, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 9, 2020
• Study Start: October 20, 2020
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)