Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05471973

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

Led by Duke University · Updated on 2026-05-06

200

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

D

Duke Clinical Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

CIED Infection Quality Initiative Demonstration Project

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Cardiovascular Implantable Electronic Device (CIED) in place
  • Presumed CIED infection defined by positive blood cultures with no other source or definite pocket infection signs
Not Eligible

You will not qualify if you...

  • Patients inappropriate for device extraction, such as those with do-not-attempt-resuscitation (DNAR) orders and limited prognosis
  • Death within one week of definitive CIED systemic infection diagnosis or positive blood culture
  • Patients with left ventricular assist devices (LVADs)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

Total: 3 locations

1

Northwestern

Chicago, Illinois, United States, 60611

Actively Recruiting

2

Atrium Health

Charlotte, North Carolina, United States, 28203

Not Yet Recruiting

3

Moses Cone

Greensboro, North Carolina, United States, 27401

Not Yet Recruiting

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Research Team

K

Kimberly Ward, MPH

S

Sarah Brady

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

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.

Nkiru Osude, Christopher B Granger, Rebecca Young...

https://pubmed.ncbi.nlm.nih.gov/40876585