CIED Infection Quality Initiative Demonstration Project (RECTIFY)

Duke University

Status: Enrolling

Conditions: Infections

Treatments: Other: Measurement and Feedback; Other: Multidisciplinary Team; Other: Outreach Visits; Other: Multifaceted Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05471973

Pro00110118

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Quality Improvement Program

Other group

Description:

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.

Treatment:

Other: Multidisciplinary Team

Other: Measurement and Feedback

Other: Multifaceted Intervention

Other: Outreach Visits