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

NCT ID: NCT04620486

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2022-12-20

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.

Conditions

Infections, Bacterial; Sepsis; Alert Fatigue, Health Personnel

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active Best Practice Alert

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.

Group Type: EXPERIMENTAL

Epic Best Practice Alert

Intervention Type: OTHER

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

Inactive Best Practice Alert

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Epic Best Practice Alert

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sayon Dutta, MD

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sayon Dutta, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36669909 (View on PubMed)

Other Identifiers

2020P001996

Identifier Type: -

Identifier Source: org_study_id