Skip to content

De-Implementation of Inappropriate Antimicrobial Use After Cardiac Device Procedures

Promoting De-Implementation of Inappropriate Antimicrobial Use in Cardiac Device Procedures By Expanding Audit and Feedback

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05020418
Acronym
CIED
Enrollment
5469
Registered
2021-08-25
Start date
2023-03-01
Completion date
2025-12-01
Last updated
2026-07-21

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

Conditions

Antibiotics Causing Adverse Effects in Therapeutic Use

Keywords

cardiac devices, antimicrobial use, chart review, learning/unlearning, de-implementation, de-adoption, Hybrid III implementation trial, antimicrobial stewardship, peri-operative antimicrobial use, peri-procedural antimicrobial use, peri-procedural infection control, stepped-wedge

Brief summary

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.

Detailed description

Aim I tests the hypothesis that a multi-faceted implementation/deimplementation bundle (I/D) of strategies that includes educational sessions with members of electrophysiology teams and locally-adapted monthly surveillance reports about guideline-concordant pre-procedural antimicrobial use and guideline-discordant post-procedural antimicrobial use, 90-day incidence of CIED infections, and 90-day incidence of C. difficile infections and 7-day incidence of AKI that will be delivered to local infectious diseases champions and shared with electrophysiology teams using blended facilitation will promote uptake of best practices and improve outcomes. This hypothesis incorporates learning/unlearning and fills a major gap caused by the dearth of rigorous de- implementation and de-adoption studies. Aim II tests the hypothesis that electronic health records (EHRs) and medical informatics have advanced to the point that it will be feasible, during the next four years, to establish an audit and feedback surveillance system that can be scaled and disseminated widely across the VA. This study will use mixed qualitative and quantitative methods to address the study aims. This will include interviews with key stakeholders and quantitative measurement of quality metrics (e.g., pre-and post-procedure antimicrobial use) and outcomes (e.g., cardiac device infections, acute kidney injuries, C. difficile infections). All patients receiving a cardiac device implantation within the VA healthcare system during the study period may be potentially included. Medical records previously reviewed and accessed may also be included for validation, testing, and optimization of electronic algorithms. In addition to the VA patients who will participate, key stakeholders for infection prevention in the cardiac device laboratory (e.g., providers, nurses, electrophysiology laboratory staff) will also participate in interviews. Active implementation will occur at 3 VA sites receiving the high-intensity I/D bundle. 8 matched control sites will be selected for comparison. High quality studies establish that prolonged prophylaxis has no beneficial impact on CIED-related infection rates but worsens outcomes and leads to preventable deaths. Despite guidelines specifically recommending against prolonged prophylaxis, this practice is common in cardiac electrophysiology laboratories, including VA and non-VA hospitals. At the same time, antimicrobial resistance and overuse represent critical threats to the health of the population. This intersection - inappropriate prescribing and a critical need to improve use-- creates an urgent need for research into methods to promote adoption of best antimicrobial use and de-implementation of ineffective and harmful prescribing. IT-based solutions for improving antimicrobial use, including antimicrobial prophylaxis, is a quality-improvement strategy endorsed by The Joint Commission. This project will advance this concept and couple learning/unlearning processes to promote uptake of best practices. If effective, this model can be replicated in other settings of care to improve antimicrobial use.

Interventions

OTHERChart Review

Intervention sites will receive a multi-faceted implementation intervention, which will include external and internal blended facilitation, education materials for providers and patients, and audit and feedback about practices and outcomes with benchmarking to non-intervention sites.

Sponsors

VA Office of Research and Development
Lead SponsorFED
VA Boston Healthcare System
CollaboratorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Cardiac device procedures performed within the national VA healthcare system during the period from Fiscal Year (FY) 16-24 will be identified using a list of relevant Current Procedural Terminology (CPT) codes. Based on our preliminary results, we anticipate that the VA Corporate Data Warehouse (CDW) EP Procedures Cohort (electronic surveillance cohort) will include approximately 100,000 cardiac device cases. Because this cohort is based in CDW, once a Veteran undergoing a device procedure is identified using CPT codes, the orders, procedures, and consults that occurred during the 90-day window following the procedure can be extracted from the VA Electronic Health Record (EHR) In addition to the full cohort, the implementation bundle will be tested at the three high-volume intervention sites (\ 1500 cases per year). Roll out of the interventions will occur in a stepped manner, such that pre- and post- intervention data will be collected at all sites.

Eligibility

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

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

* None

Design outcomes

Primary

MeasureTime frameDescription
cardiac device infection90 daysIncidence of cardiac device infections
C. difficile infections90 daysIncidence of C. difficile infections
Acute Kidney Injury (AKI)7 daysIncidence of AKI
Pre-procedure Antimicrobial Use1 dayProportion of cases with guideline-concordant pre-procedure antimicrobial use defined as appropriate antimicrobials administered within 1 hour prior to incision.
Post-procedure Antimicrobial Use14 daysProportion of cases with guideline-concordant post-procedure antimicrobial use defined as antibiotics administered for prevention of cardiac device infection (not for pre-existing infection) lasting for greater than 24 hours following the procedure.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORWestyn Branch-Elliman, MD

VA Boston Healthcare System

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026