De-Implementation of Inappropriate Antimicrobial Use After Cardiac Device Procedures

NCT05020418 | Completed

• 2 other identifiers: IIR 20-076IRB 1585926
• Study Type: interventional
• Target: 5,469
• 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

The Intervention Arm is receipt of the high-intensity implementation/deimplementation (I/D) bundle (3 sites). Control sites will be matched based on similar practices but not receive the high-intensity I/D bundle.

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: collaborator
• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

Related Publications (15)

• 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 BACKGROUND

• La J, Fillmore NR, Do NV, Brophy M, Monach PA, Branch-Elliman W. Factors associated with the speed and scope of diffusion of COVID-19 therapeutics in a nationwide healthcare setting: a mixed-methods investigation. Health Res Policy Syst. 2022 Dec 14;20(1):134. doi: 10.1186/s12961-022-00935-x.

  PMID: 36517793 BACKGROUND

• Shenoy ES, Branch-Elliman W. Automating surveillance for healthcare-associated infections: Rationale and current realities (Part I/III). Antimicrob Steward Healthc Epidemiol. 2023 Feb 10;3(1):e25. doi: 10.1017/ash.2022.312. eCollection 2023.

  PMID: 36865706 BACKGROUND

• Branch-Elliman W, Sundermann AJ, Wiens J, Shenoy ES. The future of automated infection detection: Innovation to transform practice (Part III/III). Antimicrob Steward Healthc Epidemiol. 2023 Feb 10;3(1):e26. doi: 10.1017/ash.2022.333. eCollection 2023.

  PMID: 36865708 BACKGROUND

• Branch-Elliman W, Sundermann AJ, Wiens J, Shenoy ES. Leveraging electronic data to expand infection detection beyond traditional settings and definitions (Part II/III). Antimicrob Steward Healthc Epidemiol. 2023 Feb 10;3(1):e27. doi: 10.1017/ash.2022.342. eCollection 2023.

  PMID: 36865709 BACKGROUND

• Reyes Dassum S, Mull HJ, Golenbock S, Lamkin RP, Epshtein I, Shin MH, Strymish JM, Blumenthal KG, Colborn K, Branch-Elliman W. A Novel Informatics Tool to Detect Periprocedural Antibiotic Allergy Adverse Events for Near Real-time Surveillance to Support Audit and Feedback. JAMA Netw Open. 2023 May 1;6(5):e2313964. doi: 10.1001/jamanetworkopen.2023.13964.

  PMID: 37195660 BACKGROUND

• Branch-Elliman W, Elwy AR, Chambers DA. Embracing dynamic public health policy impacts in infectious diseases responses: leveraging implementation science to improve practice. Front Public Health. 2023 Aug 17;11:1207679. doi: 10.3389/fpubh.2023.1207679. eCollection 2023.

  PMID: 37663826 BACKGROUND

• Young S, Mull HJ, Golenbock S, Stolzmann K, Shin M, Lamkin RP, Linsenmeyer KD, Epshtein I, Kalver E, Strymish JM, Branch-Elliman W. Factors associated with uptake of guideline-recommended cardiovascular implantable electronic device management: a nationwide, retrospective cohort study. Antimicrob Steward Healthc Epidemiol. 2023 Oct 25;3(1):e187. doi: 10.1017/ash.2023.422. eCollection 2023.

  PMID: 38028909 BACKGROUND

• Al Lawati H, Shin M, Lamkin R, Thompson T, Epshtein I, Mull H, Basnet Thapa D, Drekonja D, Rodriguez-Barradas MC, Xu TH, Gold H, Elwy AR, Strymish J, Branch-Elliman W. Engaging patients in antimicrobial stewardship: co-designed educational tool to improve periprocedural care through de-implementation of guideline-discordant antimicrobial use. Antimicrob Steward Healthc Epidemiol. 2023 Sep 28;3(1):e163. doi: 10.1017/ash.2023.420. eCollection 2023.

  PMID: 38028930 BACKGROUND

• Al Lawati HJ, Harvey KL, Shin M, Mull H, Lamkin RP, Golenbock S, Basnet-Thapa D, Strymish JM, Lee M, Gold H, Bidwell Goetz M, Branch-Elliman W. Operationalizing an adverse event detection surveillance system to support antimicrobial stewardship activities: perceptions and insights from the SHEA research network. Infect Control Hosp Epidemiol. 2024 Dec;45(12):1468-1471. doi: 10.1017/ice.2024.141. Epub 2024 Oct 30.

  PMID: 39473228 BACKGROUND

• Mull HJ, Golenbock SW, Basnet Thapa D, Shin MH, Harvey KL, Lamkin RP, Strymish J, Branch-Elliman W. Cardiac Implantable Device Infection Surveillance Algorithm. JAMA Netw Open. 2025 Jun 2;8(6):e2514079. doi: 10.1001/jamanetworkopen.2025.14079.

  PMID: 40471582 BACKGROUND

• Harvey L, Abdulkerim H, Strymish J, Ryan SK, Boudreau J, Gifford A, Hyde J, Branch-Elliman W. Infectious Complications of Substance Use: A Retrospective Cohort Study of Hospitalized Veterans. Open Forum Infect Dis. 2025 May 17;12(6):ofaf301. doi: 10.1093/ofid/ofaf301. eCollection 2025 Jun.

  PMID: 40476030 BACKGROUND

• Golenbock SW, Basnet D, Mull HJ, Lamkin R, Harvey K, Shin M, Strymish JM, Leatherman S, Ferguson R, Branch-Elliman W. Development of a feasible and portable electronic flag for near-real-time identification of renal replacement therapy in the Veterans Health Administration. Antimicrob Steward Healthc Epidemiol. 2025 Oct 23;5(1):e279. doi: 10.1017/ash.2025.10166. eCollection 2025.

  PMID: 41180296 BACKGROUND

• Basnet D, Mull HJ, Morgan DJ, Golenbock SW, Lamkin RP, Strymish JM, Harvey K, Yuen K, Schweizer ML, Drekonja D, Rodriguez-Barradas MC, Branch-Elliman W. Leveraging a large language model to support expansion of surveillance activities to include cardiovascular implantable device infections in a large, integrated national healthcare system. Infect Control Hosp Epidemiol. 2026 Jan 23;47(4):1-6. doi: 10.1017/ice.2025.10384. Online ahead of print.

  PMID: 41572724 BACKGROUND

• Basnet D, Golenbock S, Strymish JM, Mull HJ, Lamkin RP, Shin M, Harvey K, Karchmer AW, Branch-Elliman W. Bloodstream Infections Among Veterans With Cardiac Implantable Electronic Devices: Source Identification and Intervention Strategies. Open Forum Infect Dis. 2026 Feb 23;13(2):ofag020. doi: 10.1093/ofid/ofag020. eCollection 2026 Feb.

  PMID: 41737048 BACKGROUND

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: SPONSOR

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: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)