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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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
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
Northwestern
Chicago, Illinois, United States
RECRUITINGAtrium Health
Charlotte, North Carolina, United States
NOT_YET_RECRUITINGMoses Cone
Greensboro, North Carolina, United States
NOT_YET_RECRUITINGProportion 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
Time frame: 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
Time frame: Up to 12 months
Proportion of patients with extraction within 7 days of diagnosis
Proportion of patients who who receive extraction within 7 days and during index hospitalization
Time frame: Up to 12 months
Proportion of patients with extraction during index hospitalization
Time frame: Up to 12 months
Time from positive blood culture/clear pocket infection to extraction for those undergoing extraction
Time frame: Up to 12 months
Number of patients identified with suspected CIED infection
Time frame: Up to 12 months
Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction
Time frame: Up to 12 months
Number of actual extractions
Time frame: Up to 12 months
Number of patients with multi-organ failure or septic shock at time of extraction
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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.
Time frame: Up to 12 months
Estimated healthcare utilization/costs
Time frame: Up to 12 months
Staff satisfaction as measured by a qualitative survey
Time frame: Up to 12 months
Patient satisfaction as measured by a qualitative survey
Time frame: Up to 12 months