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ISO 27001 CertifiedActively Recruiting
Led by Duke University · Updated on 2026-05-06
200
Participants Needed
3
Research Sites
N/A
Total Duration
This research aims to enhance care for patients with infections related to cardiovascular implantable electronic devices CIEDs. The project focuses on improving early detection, diagnosis, and treatment of these infections by establishing multidisciplinary teams to address gaps in current care. This initiative is a quality improvement demonstration project sponsored by Duke University to increase guideline-driven care for CIED infections. The study will collect retrospective data before starting the intervention, which will be implemented over six months and continue through data collection. After three months of starting the intervention, prospective data will be collected for 12 months. The program includes tailored patient care pathways, outreach visits, multifaceted interventions like electronic health record decision support, and ongoing feedback to healthcare providers to improve infection management and treatment timing. Participants will be monitored for how quickly and appropriately their infections are treated, including timely device extraction when needed. Researchers will track measures such as the proportion of patients receiving extraction according to guidelines, time to extraction, and patient and staff satisfaction over 12 months. The study involves regular reviews and adjustments to interventions, aiming to improve outcomes and healthcare utilization for patients with CIED infections.
CONDITIONS
CIED Infection Quality Initiative Demonstration Project
K
Kimberly Ward, MPH
S
Sarah Brady
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Duke University
Lead Sponsor
Duke Clinical Research Institute
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Multidisciplinary Quality Improvement Program | Usual Clinical Practice (Standard of Care) |
|---|---|---|
| What it is | A structured, multidisciplinary quality improvement initiative designed to identify barriers, monitor data, provide site feedback, and implement multifaceted interventions (e.g., electronic health record decision support, outreach visits, clinical pathways) to improve care for CIED infection. | The established or typical hospital/institutional process of managing CIED infections, generally based on guidelines but without a formalized, multidisciplinary quality improvement initiative or centralized feedback system. |
| Role in the trial | All enrolled participants with CIED infection receive the quality improvement intervention, which defines the trial's single-group design. | Serves as the pre-intervention or background approach to CIED infection management, forming the clinical context for the study but not directly assigned in the trial. |
| Primary use | To increase guideline-directed device extraction and optimize patient outcomes in adults with CIED infection by systematically supporting hospitals to deliver recommended care. | To treat CIED infection according to local practice, typically following published guidelines but without additional QI elements such as feedback or outreach. |
| How it is delivered or performed | Multidisciplinary teams review care, barriers, and outcomes; external experts perform outreach visits; sites receive feedback and assistance in adopting guideline-based practice; sites may implement tools like EHR decision support, new clinical pathways, and engagement with opinion leaders. | Clinical decisions regarding device infection are made by the local treating team, sometimes consulting infectious diseases or electrophysiology, but typically without structured external feedback or QI-driven interventions. |
| Evidence status | Effectiveness of the QI program is under investigation in this active clinical trial; published outcome results are not yet available. | Guideline-based standard care is backed by published evidence; outcomes vary regionally, and gaps in timely guideline adherence are documented in the literature. |
| Important limitations | As a quality improvement intervention, generalizability depends on site engagement; the program's effectiveness in different settings and its sustainability require further outcome data. | Timely and consistent adherence to guideline-directed care for CIED infection is known to be limited in routine practice due to barriers such as lack of awareness, delays in referral, and inconsistent multidisciplinary coordination. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive a multifaceted quality improvement program including multidisciplinary team interventions, outreach visits, and measurement with feedback to improve care pathways for cardiac implantable device infection.
Ongoing intervention with periodic assessments
Duration - 12 months
Participants are monitored prospectively for outcomes related to device infection and treatment effectiveness for up to 12 months after intervention start.
Regular data collection without additional visits
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Nkiru Osude, Christopher B Granger, Rebecca Young...
https://pubmed.ncbi.nlm.nih.gov/40876585/Duke University
Lead Sponsor
Duke Clinical Research Institute
Collaborating Sponsor
