- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05020418
De-Implementation of Inappropriate Antimicrobial Use After Cardiac Device Procedures (CIED)
Promoting De-Implementation of Inappropriate Antimicrobial Use Following Cardiac Device Procedures
Study Overview
Status
Intervention / Treatment
Detailed Description
Aim I tests the hypothesis that a multi-faceted implementation strategy 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, a passive dissemination process will occur at all VA sites with a cardiac device laboratory (~78 VA sites).
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02130
- VA Boston Healthcare System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cardiac Device Cohort
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardiac device infection
Time Frame: 90 days
|
Incidence of cardiac device infections
|
90 days
|
C. difficile infections
Time Frame: 90 days
|
Incidence of C. difficile infections
|
90 days
|
Acute Kidney Injury (AKI)
Time Frame: 7 days
|
Incidence of AKI
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7 days
|
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.
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1 day
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Post-procedure Antimicrobial Use
Time Frame: 14 days
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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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Westyn Branch-Elliman, MD, VA Boston Healthcare System
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB 1585926
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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