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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04620486
Enrollment
420
Registered
2020-11-09
Start date
2020-10-20
Completion date
2022-12-20
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alert Fatigue, Health Personnel, Infections, Bacterial, Sepsis

Keywords

Antibiotics, Electronic alert

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.

Interventions

OTHEREpic Best Practice Alert

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

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Delay Time to Next Antibiotic DoseBetween 0 and 24 hours after expected antibiotic re-administrationThe length of delay between time of expected antibiotic re-administration and the actual time of antibiotic re-administration

Secondary

MeasureTime frameDescription
Hospital Length-of-stayThrough study completion, up to 1 yearNumber of days that patient is hospitalized
Admission to Intensive Care Unit (ICU)Through study completion, up to 1 yearWhether a patient received care in the Intensive Care Unit (ICU) during hospital admission
In-hospital mortalityThrough study completion, up to 1 yearWhether a patient received died during hospital admission

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026