Clinical trial NCT05471973: CIED Infection Quality Initiative Demonstration Project
Official title: The Review and Improvement of Cardiac Implantable Device Infection Quality Initiative (RECTIFY) Demonstration Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infections
Keywords: Cardiac Implantable Electronic Devices
Quality improvement
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
name: Philips Healthcare
First posted: 2022-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines)
timeFrame: Up to 12 months
measure: Proportion of patients with CIEDs and definite pocket infections who receive extraction (per guidelines)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Proportion of patients with extraction within 7 days of diagnosis
timeFrame: Up to 12 months
measure: Proportion of patients with extraction during index hospitalization
timeFrame: Up to 12 months
measure: Time from positive blood culture/clear pocket infection to extraction for those undergoing extraction
timeFrame: Up to 12 months
measure: Number of patients identified with suspected CIED infection
timeFrame: Up to 12 months
measure: Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction
timeFrame: Up to 12 months
measure: Number of actual extractions
timeFrame: Up to 12 months
measure: Number of patients with multi-organ failure or septic shock at time of extraction
timeFrame: Up to 12 months
measure: Estimated healthcare utilization/costs
timeFrame: Up to 12 months
measure: Staff satisfaction as measured by a qualitative survey
timeFrame: Up to 12 months
measure: Patient satisfaction as measured by a qualitative survey
timeFrame: Up to 12 months
Other outcomes:
measure: Mortality
timeFrame: Up to 12 months
measure: Length of stay
timeFrame: Up to 12 months
measure: Days of antibiotic treatments
timeFrame: Up to 12 months
Locations:
city: Chicago
country: United States
facility: Northwestern
state: Illinois
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Greensboro
country: United States
facility: Moses Cone
state: North Carolina
Study officials:
affiliation: Duke Clinical Research Institute
name: Chris Granger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Clinical Research Institute
name: Sean Pokorney, MD
role: PRINCIPAL_INVESTIGATOR
References: