CIED Infection Quality Initiative Demonstration Project (RECTIFY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infections
• Intervention / Treatment: Other: Multidisciplinary Team; Other: Outreach Visits; Other: Multifaceted Intervention; Other: Measurement and Feedback

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimberly Ward, MPH; Phone Number: 9196606409; Email: kimberly.t.ward@duke.edu
• Study Contact Backup: Name: Sarah Brady; Phone Number: 9196818928; Email: sarah.brady@duke.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern
      • Contact: Anna Huskin, RN, BSN
      • Principal Investigator: Albert Lin, MD
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Not yet recruiting
      • Atrium Health
      • Principal Investigator: Rohit Mehta, MD
      • Contact: Melissa Myers
      • Contact: Nicole Boisvert
      • Principal Investigator: Satish Misra, MD
    • Greensboro, North Carolina, United States, 27401
      • Not yet recruiting
      • Moses Cone
      • Contact: Cameron Lambert, MD
      • Principal Investigator: Cameron Lambert, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Quality Improvement Program; 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.

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; Other: 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; Other: 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; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		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

Other Outcome Measures

Outcome Measure	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
Days of antibiotic treatments	Number of days patient received antibiotics	Up to 12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Duke Clinical Research Institute; Philips Healthcare
• Investigators: Principal Investigator: Chris Granger, MD, Duke Clinical Research Institute; Principal Investigator: Sean Pokorney, MD, Duke Clinical Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Quality improvement; Cardiac Implantable Electronic Devices
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Health Services Administration; Investigative Techniques; Patient Care Management; Weights and Measures; Patient Care Team
• Other Study ID Numbers: Pro00110118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No