RECRUITING

CIED Infection Quality Initiative Demonstration Project

Conditions

Infections Cardiac Implantable Electronic Devices Quality improvement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-10

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05471973

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Kimberly Ward, MPH

CONTACT

9196606409

kimberly.t.ward@duke.edu

Sarah Brady

CONTACT

9196818928

sarah.brady@duke.edu

Principal Investigator

Chris Granger, MD

PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Sean Pokorney, MD

PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Study Locations (Sites)

Northwestern

Chicago, Illinois, 60611

United States

Atrium Health

Charlotte, North Carolina, 28203

United States

Moses Cone

Greensboro, North Carolina, 27401

United States

Collaborators and Investigators

Sponsor: Duke University

Chris Granger, MD, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute
Sean Pokorney, MD, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-10

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-05-10

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Cardiac Implantable Electronic Devices
Quality improvement

Additional Relevant MeSH Terms

Infections