De-Implementation of Inappropriate Antimicrobial Use After Cardiac Device Procedures

NCT05020418 | Unknown

• 1 other identifier: IRB 1585926
• Study Type: interventional
• Target: 100,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• cardiac device infection

  Incidence of cardiac device infections

  90 days

• C. difficile infections

  Incidence of C. difficile infections

  90 days

• Acute Kidney Injury (AKI)

  Incidence of AKI

  7 days

• Pre-procedure Antimicrobial Use

  Proportion of cases with guideline-concordant pre-procedure antimicrobial use defined as appropriate antimicrobials administered within 1 hour prior to incision.

  1 day

• Post-procedure Antimicrobial Use

  Proportion 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.

  14 days

Study Arms (1)

Cardiac Device Cohort

EXPERIMENTAL

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.

Other: Chart Review

Interventions

Chart Review OTHER

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.

Cardiac Device Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• VA Boston Healthcare System: lead

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

• Branch-Elliman W, Lamkin R, Shin M, Mull HJ, Epshtein I, Golenbock S, Schweizer ML, Colborn K, Rove J, Strymish JM, Drekonja D, Rodriguez-Barradas MC, Xu TH, Elwy AR. Promoting de-implementation of inappropriate antimicrobial use in cardiac device procedures by expanding audit and feedback: protocol for hybrid III type effectiveness/implementation quasi-experimental study. Implement Sci. 2022 Jan 29;17(1):12. doi: 10.1186/s13012-022-01186-8.

  PMID: 35093104 DERIVED

Study Officials

• Westyn Branch-Elliman, MD

  VA Boston Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 25, 2021
• Study Start: March 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)