Automated Feedback for Reducing Antibiotic Use After Cardiac Device Procedures

(CIED Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Boston Healthcare System

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce unnecessary antibiotic use in individuals who have undergone cardiac device procedures, such as pacemakers. The focus is on using automated feedback to ensure adherence to guidelines, potentially improving patient outcomes. If successful, these methods will be implemented across the VA healthcare system. Patients who have had a cardiac device procedure at a VA facility may be suitable candidates for this trial. As an unphased trial, this study offers patients the chance to contribute to innovative healthcare improvements that could benefit many others.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for reducing antibiotic use after cardiac device procedures?

Research has shown that using fewer antibiotics during heart device procedures is generally safe. The goal is to avoid unnecessary antibiotics. Studies have found that this approach does not increase infections in heart devices like pacemakers. Instead, it can reduce other non-heart-related side effects. Patients are not at a higher risk for heart device infections and may experience fewer antibiotic side effects. Overall, this treatment is well-tolerated and safe for patients undergoing these procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on reducing unnecessary antibiotic use after cardiac device procedures. Unlike traditional approaches that rely on broad antibiotic administration as a preventive measure, this trial uses automated feedback to identify and de-implement inappropriate antimicrobial use. This method could lead to more precise antibiotic use, minimizing side effects and combating antibiotic resistance. By streamlining how antibiotics are prescribed, this trial has the potential to improve patient outcomes and promote more sustainable healthcare practices.

What evidence suggests that this method is effective for reducing inappropriate antimicrobial use after cardiac device procedures?

Research has shown that reducing unnecessary antibiotic use after heart device surgeries can improve patient health. This trial focuses on eliminating inappropriate antimicrobial use following cardiac device procedures. Studies have found that many patients receive unnecessary antibiotics, leading to antibiotic resistance and other complications. Stopping these treatments can potentially enhance safety for patients with heart devices. Early results suggest that when hospitals adhere to guidelines, patients experience fewer infections and complications. This approach aims to replace ineffective practices with better ones, leading to improved care. ^{1 2 3 5 6}

Who Is on the Research Team?

Westyn Branch-Elliman, MD

Principal Investigator

VA Boston Healthcare System

Are You a Good Fit for This Trial?

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.

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

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Educational sessions and surveillance reports are used to promote best practices in antimicrobial use

4 years

Monthly surveillance reports

Follow-up

Participants are monitored for cardiac device infections, C. difficile infections, and acute kidney injuries

90 days

What Are the Treatments Tested in This Trial?

Interventions

• De-Implementation of Inappropriate Antimicrobial Use After Cardiac Device Procedures

Trial Overview 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.

How Is the Trial Designed?

Group I: Cardiac Device Cohort Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

VA Boston Healthcare System

Lead Sponsor

Trials

73

Recruited

971,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05020418

De-Implementation of Inappropriate Antimicrobial Use After ... 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 ...

2. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-022-01186-8

protocol for hybrid III type effectiveness/implementation quasi ... This study will assess whether a multifaceted intervention mapped to identified de-implementation barriers leads to measurable improvements.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35093104/

protocol for hybrid III type effectiveness/implementation ... This study will assess whether a multifaceted intervention mapped to identified de-implementation barriers leads to measurable improvements.

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05020418?keyword=%22Antimicrobial%22

De-Implementation of Inappropriate Antimicrobial Use After ... ~This study will use mixed qualitative and quantitative methods to address the study aims. This will include interviews with key stakeholders and quantitative ...

5. researchgate.net researchgate.net/publication/357041564_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

(PDF) Promoting De-Implementation of Inappropriate ... Effective de-implementation models often include replacement of an ineffective practice with an alternative. We co-developed patient education materials as a ...

6. clinconnect.io clinconnect.io/trials/NCT05020418

De-Implementation of Inappropriate Antimicrobial Use This VA study is testing a plan to reduce unnecessary antibiotic use around cardiac device procedures (like pacemakers or defibrillators). The goal is to lower ...