Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT05471973

Conditions

Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multidisciplinary Team

Outreach Visits

Multifaceted Intervention

Measurement and Feedback

Study Details

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

Study ID

NCT05471973

Start date

May 10, 2023

Status verified date

May, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Quality Improvement Program

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.

Interventions

Multidisciplinary Team

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

Outreach Visits

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

Multifaceted Intervention

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

Measurement and Feedback

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.

Primary outcome measure

  • Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines) [ Time Frame: Up to 12 months ]
  • Proportion of patients with CIEDs and definite pocket infections who receive extraction (per guidelines) [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

Kimberly Ward, MPH

9196606409kimberly.t.ward@duke.edu

Sarah Brady

9196818928sarah.brady@duke.edu

Locations

Northwestern

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Albert Lin, MD

More Information

Sponsor

Duke University

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Cardiac Implantable Electronic Devices
  • Quality improvement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-06.