CIED Infection Quality Initiative Demonstration Project

Not Applicable

Recruiting

• Conditions: Infections
• Interventions: Other: Multidisciplinary Team; Other: Outreach Visits; Other: Multifaceted Intervention; Other: Measurement and Feedback

• Registration Number: NCT05471973
• Lead Sponsor: Duke University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-25
• Study Start: 2023-05-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age ≥18 years

• Cardiovascular Implantable Electronic Device (CIED) in place

• Presumed CIED infection, as defined by:

  1. 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
  2. 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Quality Improvement Program	Multidisciplinary Team	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.
Quality Improvement Program	Multifaceted Intervention	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.
Quality Improvement Program	Measurement and Feedback	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.
Quality Improvement Program	Outreach Visits	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines)	Up to 12 months	Proportion of patients with CIEDs and positive blood cultures, who receive extraction
Proportion of patients with CIEDs and definite pocket infections who receive extraction (per guidelines)	Up to 12 months	Proportion of patients with CIEDs and probable device infection, who receive extraction

Secondary Outcome Measures

Name	Time	Method
Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction	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
Proportion of patients with extraction within 7 days of diagnosis	Up to 12 months	Proportion of patients who who receive extraction within 7 days and during index hospitalization
Proportion of patients with extraction during index hospitalization	Up to 12 months
Number of actual extractions	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
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

Trial Locations

Locations (3)

Moses Cone; 🇺🇸 Greensboro, North Carolina, United States

Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

Northwestern; 🇺🇸 Chicago, Illinois, United States