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NCT Number: NCT05471973

CIED Infection Quality Initiative Demonstration Project

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.

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Key information

Conditions

Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Multidisciplinary Team

Other

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

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

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

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 outcomes

  1. 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 positive blood cultures, who receive extraction

  2. Proportion of patients with CIEDs and definite pocket infections who receive extraction (per guidelines)

    Time frame: Up to 12 months

    Proportion of patients with CIEDs and probable device infection, who receive extraction

Secondary outcomes

  1. Proportion of patients with extraction within 7 days of diagnosis

    Time frame: Up to 12 months

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

  2. Proportion of patients with extraction during index hospitalization

    Time frame: Up to 12 months

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

    Time frame: Up to 12 months

  4. Number of patients identified with suspected CIED infection

    Time frame: Up to 12 months

  5. Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction

    Time frame: Up to 12 months

  6. Number of actual extractions

    Time frame: Up to 12 months

  7. Number of patients with multi-organ failure or septic shock at time of extraction

    Time frame: Up to 12 months

  8. Estimated healthcare utilization/costs

    Time frame: Up to 12 months

  9. Staff satisfaction as measured by a qualitative survey

    Time frame: Up to 12 months

  10. Patient satisfaction as measured by a qualitative survey

    Time frame: Up to 12 months

Other outcomes

  1. Mortality

    Time frame: Up to 12 months

    Number of deaths from CIED infection

  2. Length of stay

    Time frame: Up to 12 months

    Clinical outcomes: number of days of hospitalization

  3. Days of antibiotic treatments

    Time frame: Up to 12 months

    Number of days patient received antibiotics

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Ward, MPH

CONTACT

[email protected]

9196606409

Sarah Brady

CONTACT

[email protected]

9196818928

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Duke Clinical Research Institute
  • Philips Healthcare

Registry information

Official study title

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

Acronym: RECTIFY

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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