Clinical trial NCT04620486: Effect of BPA on Anchor Antibiotic Continuity in the ED: Randomized Controlled Trial
Official title: Effect of BPA on Anchor Antibiotic Continuity in the ED: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections, Bacterial
Sepsis
Alert Fatigue, Health Personnel
Keywords: Antibiotics
Electronic alert
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Delay Time to Next Antibiotic Dose
timeFrame: Between 0 and 24 hours after expected antibiotic re-administration
Secondary outcomes:
measure: Hospital Length-of-stay
timeFrame: Through study completion, up to 1 year
measure: Admission to Intensive Care Unit (ICU)
timeFrame: Through study completion, up to 1 year
measure: In-hospital mortality
timeFrame: Through study completion, up to 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sayon Dutta, MD
role: PRINCIPAL_INVESTIGATOR
References: