CIED Infection Quality Initiative Demonstration Project

NCT05471973 | Recruiting

• 1 other identifier: Pro00110118
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Infections

Keywords

Cardiac Implantable Electronic Devices; Quality improvement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Proportion of patients with extraction within 7 days of diagnosis

  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

Other Outcomes (3)

• Mortality

  Up to 12 months

• Length of stay

  Up to 12 months

• Days of antibiotic treatments

  Up to 12 months

Study Arms (1)

Quality Improvement Program

OTHER

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; Other: Outreach Visits; Other: Multifaceted Intervention; Other: Measurement and Feedback

Interventions

Multidisciplinary Team OTHER

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

Quality Improvement Program

Outreach Visits OTHER

An outreach visit consulting group from the coordinating center and trial leadership will provide external guidance on reviewing data, defining barriers, and implementing interventions

Quality Improvement Program

Multifaceted Intervention OTHER

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

Quality Improvement Program

Measurement and Feedback OTHER

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.

Quality Improvement Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• Duke Clinical Research Institute: collaborator
• Philips Healthcare: collaborator

Study Sites (3)

Northwestern

Chicago, Illinois, 60611, United States

RECRUITING

Atrium Health

Charlotte, North Carolina, 28203, United States

NOT YET RECRUITING

Moses Cone

Greensboro, North Carolina, 27401, United States

NOT YET RECRUITING

Related Publications (1)

• Osude N, Granger CB, Young R, Al-Khalidil H, Ward K, Leyva M, Lambert C, Tillery M, Lin A, Mehta R, Satish M, Peigh G, Wright A, Epstein LM, Lundqvist CB, Piccini JP, Sohail MR, Pokorney SD. REview and improvement of cardiac implanTable device Infection management qualitY initiative (RECTIFY): Rationale and design for a cardiac implantable electronic device infection quality initiative demonstration project. Am Heart J. 2026 Feb;292:107264. doi: 10.1016/j.ahj.2025.08.017. Epub 2025 Aug 26.

  PMID: 40876585 DERIVED

MeSH Terms

Conditions

Infections

Interventions

Patient Care Team; Weights and Measures

Intervention Hierarchy (Ancestors)

Patient Care Management; Health Services Administration; Investigative Techniques

Study Officials

• Chris Granger, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Sean Pokorney, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Ward, MPH

CONTACT

9196606409; kimberly.t.ward@duke.edu

Sarah Brady

CONTACT

9196818928; sarah.brady@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: May 10, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)