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Antimicrobial Stewardship
Automated Feedback for Reducing Antibiotic Use After Cardiac Device Procedures (CIED Trial)
N/A
Waitlist Available
Led By Westyn Branch-Elliman, MD
Research Sponsored by VA Boston Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether automated feedback can help medical staff better follow guidelines for antimicrobial prophylaxis for CIED procedures, leading to improved patient outcomes.
Who is the study for?
This trial is open to any adult patient at a VA hospital who has had a cardiac device procedure in the electrophysiology lab and whose data is recorded in the national VA Electronic Health Record (EHR). There are no specific exclusion criteria.
What is being tested?
The study aims to improve adherence to guidelines for antibiotic use after cardiac device procedures using automated audit and feedback. A special bundle of strategies will be tested across three sites, with potential expansion throughout the VA healthcare system if successful.
What are the potential side effects?
Since this trial involves chart review rather than direct medical interventions, there are no typical medication side effects; however, there may be risks associated with data privacy or emotional discomfort from participation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acute Kidney Injury (AKI)
C. difficile infections
Post-procedure Antimicrobial Use
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cardiac Device CohortExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
VA Boston Healthcare SystemLead Sponsor
70 Previous Clinical Trials
870,558 Total Patients Enrolled
Westyn Branch-Elliman, MDPrincipal InvestigatorVA Boston Healthcare System
1 Previous Clinical Trials
50 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Not applicable.
Research Study Groups:
This trial has the following groups:- Group 1: Cardiac Device Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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