Infections
Conditions
Keywords
Cardiac Implantable Electronic Devices, Quality improvement
Brief 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.
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
OTHERMultidisciplinary 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
OTHEROutreach 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
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
OTHERMeasurement 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
Duke University
Duke Clinical Research Institute
Philips Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines) | Up to 12 months | Proportion of patients with CIEDs and positive blood cultures, who receive extraction |
| Proportion of patients with CIEDs and definite pocket infections who receive extraction (per guidelines) | Up to 12 months | Proportion of patients with CIEDs and probable device infection, who receive extraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with extraction within 7 days of diagnosis | Up to 12 months | Proportion of patients who who receive extraction within 7 days and during index hospitalization |
| Proportion of patients with extraction during index hospitalization | 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 | — |
Countries
United States
Contacts
CONTACTKimberly Ward, MPH
CONTACTSarah Brady
PRINCIPAL_INVESTIGATORChris Granger, MD
Duke Clinical Research Institute
PRINCIPAL_INVESTIGATORSean Pokorney, MD
Duke Clinical Research Institute
Outcome results
None listed