CIED Infection Quality Initiative Demonstration Project
NCT05471973 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-05-06
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.
Conditions
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.
Sponsors & Collaborators
-
Duke Clinical Research Institute
collaborator OTHER -
Philips Healthcare
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Chris Granger, MD · Duke Clinical Research Institute
-
Sean Pokorney, MD · Duke Clinical Research Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-10
- Primary Completion
- 2027-03-31
- Completion
- 2027-03-31
Countries
- United States
Study Locations
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