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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Infections, Bacterial; Alert Fatigue, Health Personnel
• Intervention / Treatment: Other: Epic Best Practice Alert

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.

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andy Hung-Yi Lee, MD; Phone Number: 617-726-2000; Email: alee85@partners.org
• Study Contact Backup: Name: Sayon Dutta, MD; Phone Number: 857-282-4601; Email: sdutta1@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Epic Best Practice Alert; This is a customized Best Practice Alert created at Mass General Brigham in the institutional Epic electronic medical record system.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length-of-stay	Number of days that patient is hospitalized	Through study completion, up to 1 year
Admission to Intensive Care Unit (ICU)	Whether a patient received care in the Intensive Care Unit (ICU) during hospital admission	Through study completion, up to 1 year
In-hospital mortality	Whether a patient received died during hospital admission	Through study completion, up to 1 year

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Sayon Dutta, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Antibiotics; Electronic alert
• Additional Relevant MeSH Terms: Behavioral Symptoms; Infections; Bacterial Infections and Mycoses; Mental Fatigue; Fatigue; Bacterial Infections; Alert Fatigue, Health Personnel
• Other Study ID Numbers: 2020P001996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Given HIPAA concerns and lack of scientific need, we do not plan on sharing individual participant data (IPD).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No