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Multidisciplinary Care Program for CIED Infections (RECTIFY Trial)
N/A
Recruiting
Led By Sean Pokorney, 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
RECTIFY Trial 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.Check my eligibility
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.See study design
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.
RECTIFY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Communicable Diseases
Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines)
Secondary outcome measures
Estimated healthcare utilization/costs
Number of actual extractions
Number of patients identified with suspected CIED infection
+7 moreOther outcome measures
Days of antibiotic treatments
Length of stay
Mortality
RECTIFY 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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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,359 Previous Clinical Trials
3,420,109 Total Patients Enrolled
28 Trials studying Infections
437,715 Patients Enrolled for Infections
Duke Clinical Research InstituteOTHER
63 Previous Clinical Trials
241,332 Total Patients Enrolled
1 Trials studying Infections
42 Patients Enrolled for Infections
Philips HealthcareIndustry Sponsor
125 Previous Clinical Trials
282,126 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not a candidate for device removal due to my do-not-resuscitate (DNAR) status or because it won't improve my prognosis.My infection diagnosis or positive blood culture is not related to my implanted cardiac device.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Quality Improvement Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications for this research project being accepted at the present time?
"Per the records on clinicaltrials.gov, this particular medical study is not presently recruiting participants. This trial was initially posted in March of 2023 and ceased recruitment actions at the end of November 2022; however, there are 772 other studies currently looking for patients to join them."
Answered by AI
At how many distinct sites is the experiment accessible to participants?
"This clinical trial is recruiting participants from four distinct medical centres, including Atrium Health in Charlotte, Northside Hospital Gwinnett in Lawrenceville and Northwestern University Medical Center located in Chicago. Additionally, there are 4 other locations also partaking in this research initiative."
Answered by AI
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