CIED Infection Quality Initiative Demonstration Project

ConditionInfections

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorDuke University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Cardiovascular Implantable Electronic Device (CIED) in place

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

Multidisciplinary Team
Other intervention
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
Other intervention
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
Other 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
Other intervention
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.

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: Quality Improvement ProgramOther 4 interventions

Trial outcomes

Primary outcomes

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

Time frame

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

Time frame

Up to 12 months

Secondary outcomes

Proportion of patients with extraction within 7 days of diagnosis

Proportion of patients who who receive extraction within 7 days and during index hospitalization

Time frame

Up to 12 months

Proportion of patients with extraction during index hospitalization

Time frame

Up to 12 months

Time from positive blood culture/clear pocket infection to extraction for those undergoing extraction

Time frame

Up to 12 months

Number of patients identified with suspected CIED infection

Time frame

Up to 12 months

Other outcomes

Mortality

Number of deaths from CIED infection

Time frame

Up to 12 months

Length of stay

Clinical outcomes: number of days of hospitalization

Time frame

Up to 12 months

Days of antibiotic treatments

Number of days patient received antibiotics

Time frame

Up to 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Duke Clinical Research Institute

Collaborator

Philips Healthcare

Collaborator

Source ClinicalTrials.gov

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