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OpenTrials
Completed

NCT Number: NCT05020418

De-Implementation of Inappropriate Antimicrobial Use After Cardiac Device Procedures

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. cardiac device infection

    Time frame: 90 days

    Incidence of cardiac device infections

  2. C. difficile infections

    Time frame: 90 days

    Incidence of C. difficile infections

  3. Acute Kidney Injury (AKI)

    Time frame: 7 days

    Incidence of AKI

  4. Pre-procedure Antimicrobial Use

    Time frame: 1 day

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

  5. Post-procedure Antimicrobial Use

    Time frame: 14 days

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • VA Boston Healthcare System

Registry information

Official study title

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

Acronym: CIED

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 25, 2021
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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