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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
| Philips Healthcare | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quality Improvement Program | Other | The quality improvement program will consist of development and/or refinement of participating health system's patient care pathways tailored to address the gaps and barriers around recognition and treatment of CIED infections. Interventions will be customized and modified as needed based on regular reviews and implementation progress. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines) | Proportion of patients with CIEDs and positive blood cultures, who receive extraction | Up to 12 months |
| Proportion of patients with CIEDs and definite pocket infections who receive extraction (per guidelines) | Proportion of patients with CIEDs and probable device infection, who receive extraction | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with extraction within 7 days of diagnosis | Proportion of patients who who receive extraction within 7 days and during index hospitalization | Up to 12 months |
| Proportion of patients with extraction during index hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Number of deaths from CIED infection | Up to 12 months |
| Length of stay | Clinical outcomes: number of days of hospitalization | Up to 12 months |
Inclusion Criteria:
Age ≥18 years
Cardiovascular Implantable Electronic Device (CIED) in place
Presumed CIED infection, as defined by:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Ward, MPH | Contact | 9196606409 | kimberly.t.ward@duke.edu | |
| Sarah Brady | Contact | 9196818928 | sarah.brady@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chris Granger, MD | Duke Clinical Research Institute | Principal Investigator |
| Sean Pokorney, MD | Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern | Recruiting | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40876585 | Derived | 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 demonstration project. Am Heart J. 2026 Feb;292:107264. doi: 10.1016/j.ahj.2025.08.017. Epub 2025 Aug 26. |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D010348 | Patient Care Team |
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D008919 | Investigative Techniques |
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| 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 |
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| 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 |
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| 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. |
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| Up to 12 months |
| Time from positive blood culture/clear pocket infection to extraction for those undergoing extraction | Up to 12 months |
| Number of patients identified with suspected CIED infection | Up to 12 months |
| Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction | Up to 12 months |
| Number of actual extractions | Up to 12 months |
| Number of patients with multi-organ failure or septic shock at time of extraction | Up to 12 months |
| Estimated healthcare utilization/costs | Up to 12 months |
| Staff satisfaction as measured by a qualitative survey | Up to 12 months |
| Patient satisfaction as measured by a qualitative survey | Up to 12 months |
| Days of antibiotic treatments | Number of days patient received antibiotics | Up to 12 months |
| Atrium Health | Not yet recruiting | Charlotte | North Carolina | 28203 | United States |
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| Moses Cone | Not yet recruiting | Greensboro | North Carolina | 27401 | United States |
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