CIED Infection Quality Initiative Demonstration Project

Official title

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

Overview

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.

Interventions

• Other 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
• Other 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
• Other 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
• Other 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 measures

• 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]

Secondary outcome measures (10)

• Proportion of patients with extraction within 7 days of diagnosis [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]
• Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction [Time frame: Up to 12 months]
• Number of actual extractions [Time frame: Up to 12 months]
• Number of patients with multi-organ failure or septic shock at time of extraction [Time frame: Up to 12 months]
• Estimated healthcare utilization/costs [Time frame: Up to 12 months]
• Staff satisfaction as measured by a qualitative survey [Time frame: Up to 12 months]
• Patient satisfaction as measured by a qualitative survey [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

• 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 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 3 centers

• Northwestern — Chicago
• Atrium Health — Charlotte
• Moses Cone — Greensboro

Publications

• Osude N, Granger CB, Young R, Al-Khalidil H, Ward K, Leyva M, Lambert C, Tillery M, Lin A, Mehta R, Satish M, Peigh G, Wright A, Epstein LM, Lundqvist CB, Piccini JP, Sohail MR, Pokorney SD. REview and improvement of cardiac implanTable device Infection management qualitY initiative (RECTIFY): Rationale and design for a cardiac implantable electronic device infection quality initiative demonstrati PMID 40876585

Identifiers

NCT: NCT05471973 · Pro00110118

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗