Automated Feedback for Reducing Antibiotic Use After Cardiac Device Procedures

(CIED Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Boston Healthcare System

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This project will use automated audit and feedback to improve compliance with antimicrobial prophylaxis guidelines for CIED procedures that we anticipate will translate into better outcomes for our patients. A multi-faceted implementation bundle to promote de-implementation of guideline discordant care will be tested at three intervention sites. Materials and tools will then be disseminated throughout the VA healthcare system if the intervention is found to be effective.

Who Is on the Research Team?

Westyn Branch-Elliman, MD

Principal Investigator

VA Boston Healthcare System

Are You a Good Fit for This Trial?

This trial is open to any adult patient at a VA hospital who has had a cardiac device procedure in the electrophysiology lab and whose data is recorded in the national VA Electronic Health Record (EHR). There are no specific exclusion criteria.

Inclusion Criteria

This study is open to any adult VA patient with data about a cardiac device procedure performed in the electrophysiology laboratory entered into the national VA EHR.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Educational sessions and surveillance reports are used to promote best practices in antimicrobial use

4 years

Monthly surveillance reports

Follow-up

Participants are monitored for cardiac device infections, C. difficile infections, and acute kidney injuries

90 days

What Are the Treatments Tested in This Trial?

Interventions

• De-Implementation of Inappropriate Antimicrobial Use After Cardiac Device Procedures

Trial Overview The study aims to improve adherence to guidelines for antibiotic use after cardiac device procedures using automated audit and feedback. A special bundle of strategies will be tested across three sites, with potential expansion throughout the VA healthcare system if successful.

How Is the Trial Designed?

Group I: Cardiac Device Cohort Experimental Treatment 1 Intervention

This study is open to any adult VA patient with data about a cardiac device procedure performed in the electrophysiology laboratory entered into the national VA EHR. During FY 20-FY 24, we anticipate that this will include approximately 9,000 patients per year, or a total of 50,000 patients. In addition, cases that were previously accessed and used to develop the infection monitoring system, and the quality metric monitoring system, may also be included. This includes all patients entered in the VA Clinical Assessment Reporting and Tracking - Electrophysiology Cohort (CART-EP) database during the period from 2006-2016, and all VA patients who received a cardiac device procedure during the period from 2010-2019. This includes another approximately 50,000 patients, for a total of 100,000 patients.

Who Is Running the Clinical Trial?

VA Boston Healthcare System

Lead Sponsor

Trials

73

Recruited

971,000+