CIED Infection Quality Initiative Demonstration Project

Infections Clinical Trial

— RECTIFY  

Official title:

The Review and Improvement of Cardiac Implantable Device Infection Quality Initiative (RECTIFY) Demonstration Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05471973
• Other study ID #: Pro00110118
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: Kimberly Ward, MPH
• Phone: 9196606409
• Email: kimberly.t.ward[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Infections

Intervention

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
• 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
• 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
• 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.

Locations

Country	Name	City	State
United States	Atrium Health	Charlotte	North Carolina
United States	Northwestern	Chicago	Illinois
United States	Moses Cone	Greensboro	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Duke Clinical Research Institute, Philips Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	Number of deaths from CIED infection	Up to 12 months
Other	Length of stay	Clinical outcomes: number of days of hospitalization	Up to 12 months
Other	Days of antibiotic treatments	Number of days patient received antibiotics	Up to 12 months
Primary	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
Primary	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
Secondary	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
Secondary	Proportion of patients with extraction during index hospitalization		Up to 12 months
Secondary	Time from positive blood culture/clear pocket infection to extraction for those undergoing extraction		Up to 12 months
Secondary	Number of patients identified with suspected CIED infection		Up to 12 months
Secondary	Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction		Up to 12 months
Secondary	Number of actual extractions		Up to 12 months
Secondary	Number of patients with multi-organ failure or septic shock at time of extraction		Up to 12 months
Secondary	Estimated healthcare utilization/costs		Up to 12 months
Secondary	Staff satisfaction as measured by a qualitative survey		Up to 12 months
Secondary	Patient satisfaction as measured by a qualitative survey		Up to 12 months