RecruitingNot ApplicableNCT05471973

CIED Infection Quality Initiative Demonstration Project

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

Sponsor

Duke University

Enrollment

200 participants

Start Date

May 10, 2023

Study Type

INTERVENTIONAL

Conditions

Infections

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria3

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)

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Interventions

OTHERMultidisciplinary 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

OTHEROutreach 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

OTHERMultifaceted 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

OTHERMeasurement 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.