CIED Infection Quality Initiative Demonstration Project

Study Overview
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Brief Summary
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The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection. Multidisciplinary teams will be established to carry out the multifaceted intervention. This program seeks to improve early identification and diagnosis, appropriate treatment, and faster time to treatment of CIED infection.

Detailed Description
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Retrospective data will be collected pre-intervention. The interventions will then be implemented for a total of six months and will continue through the data collection period. Prospective data collection will start three months after the intervention is started and will continue for a total of 12 months.

Official Title
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The Review and Improvement of Cardiac Implantable Device Infection Quality Initiative (RECTIFY) Demonstration Project

Conditions
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Infections

Intervention / Treatment
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* Other: Multidisciplinary Team
* Other: Outreach Visits
* Other: Multifaceted Intervention
* Other: Measurement and Feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Cardiovascular Implantable Electronic Device (CIED) in place Presumed CIED infection, as defined by: Positive blood culture (two or more positive blood cultures for typical skin organisms (coagulase-negative staphylococci, Corynebacterium species, Propionobacterium species), or one positive blood culture for all other microorganisms), with no other source identified to explain the bacteremia Cases with definite evidence of pocket infection (defined as localized erythema, swelling, pain, tenderness, warmth, erosion, or drainage), if treated with antibiotics before culture, even with negative culture, will be considered device infection Exclusion Criteria: Patients who are inappropriate for device extraction, for example those who are DNAR and not using therapy to prolong survival because any procedure is considered inappropriate and/or it is unlikely that extraction would change overall prognosis Death within one week of definitive CIED systemic infection diagnosis or positive blood culture. Cases of bacteremia originating from a source other than the CIED that resolve without any evidence of CIED involvement should not be considered as CIED infection Patients with left ventricular assist devices (LVADs)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Quality Improvement Program<br>The quality improvement program will consist of development and/or refinement of participating health system's patient care pathways tailored to address the gaps and barriers around recognition and treatment of CIED infections. Interventions will be customized and modified as needed based on regular reviews and implementation progress. | Other: Multidisciplinary Team<br>* Multidisciplinary team will be established that will define gaps in care, monitor ongoing data, identify barriers to guideline-directed care, and develop and implement multifaceted intervention to address the barriers<br>Other: Outreach Visits<br>* An outreach visit consulting group from the coordinating center and trial leadership will provide external guidance on reviewing data, defining barriers, and implementing interventions<br>Other: Multifaceted Intervention<br>* These interventions are not limited to targeted engagement with non-extractors, electronic health record (EHR) decision support, creation of OR block time, use of opinion leaders, and development of clinical pathways. In addition, once patients are identified and referred to extraction centers, clinical pathways are needed to provide prompt care without clinical delay<br>Other: Measurement and Feedback<br>* The coordinating center will provide ongoing feedback related to the site's data. This will include time to diagnosis, treatment, and outcomes related to the device infection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines) | Proportion of patients with CIEDs and positive blood cultures, who receive extraction | Up to 12 months | 
| Proportion of patients with CIEDs and definite pocket infections who receive extraction (per guidelines) | Proportion of patients with CIEDs and probable device infection, who receive extraction | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with extraction within 7 days of diagnosis | Proportion of patients who who receive extraction within 7 days and during index hospitalization | Up to 12 months | 
| Proportion of patients with extraction during index hospitalization |  | Up to 12 months | 
| Time from positive blood culture/clear pocket infection to extraction for those undergoing extraction |  | Up to 12 months | 
| Number of patients identified with suspected CIED infection |  | Up to 12 months | 
| Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction |  | Up to 12 months | 
| Number of actual extractions |  | Up to 12 months | 
| Number of patients with multi-organ failure or septic shock at time of extraction |  | Up to 12 months | 
| Estimated healthcare utilization/costs |  | Up to 12 months | 
| Staff satisfaction as measured by a qualitative survey |  | Up to 12 months | 
| Patient satisfaction as measured by a qualitative survey |  | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Implantable Electronic Devices, Quality improvement