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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04620486
• Other study ID #: 2020P001996
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: December 20, 2022

Study information

• Verified date: August 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alert Fatigue, Health Personnel
• Bacterial Infections
• Infections, Bacterial
• Sepsis

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospital Length-of-stay	Number of days that patient is hospitalized	Through study completion, up to 1 year
Secondary	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
Secondary	In-hospital mortality	Whether a patient received died during hospital admission	Through study completion, up to 1 year