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Multidisciplinary Care Program for CIED Infections (RECTIFY Trial)

N/A

Recruiting

Led By Chris Granger, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will develop a model to improve care for patients with CIED infections. 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.

Who is the study for?

This trial is for adults over 18 with suspected infections of cardiovascular implantable electronic devices (CIED), evidenced by specific blood culture results or signs of infection at the device site. It excludes those who pass away within a week after diagnosis, have other sources for their bacteremia, use left ventricular assist devices, or are not candidates for device extraction.

What is being tested?

The project tests a quality initiative to improve care for CIED infections using multidisciplinary teams and interventions like outreach visits and feedback. The goal is better early detection, treatment accuracy, and reduced time to treatment in affected patients.

What are the potential side effects?

Since this study focuses on improving healthcare processes rather than testing new medications or treatments directly administered to patients, it does not list typical medication side effects. However, there may be indirect effects from changes in care practices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Communicable Diseases

Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines)

Secondary study objectives

Proportion of patients with extraction within 7 days of diagnosis

Other study objectives

Days of antibiotic treatments

Length of stay

Mortality

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Quality Improvement ProgramExperimental Treatment4 Interventions

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.

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