Multidisciplinary Care Program for CIED Infections
(RECTIFY Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
Disqualifiers: Inappropriate for extraction, Death within week, LVADs
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment?
Research shows that using a multidisciplinary team approach, where different healthcare professionals work together, can improve patient outcomes in various conditions. For example, in trauma care and sepsis management, such approaches have led to better patient care and reduced complications.
12345Is the Multidisciplinary Care Program for CIED Infections safe for humans?
Research shows that multidisciplinary care teams, which include various healthcare professionals working together, can help reduce adverse events (unwanted side effects or complications) and improve patient safety. This approach has been found to limit adverse drug events and improve overall patient outcomes, suggesting it is generally safe for humans.
678910How does the Multidisciplinary Care Program for CIED Infections differ from other treatments?
This treatment is unique because it involves a team of healthcare professionals from different specialties working together to manage CIED infections, which can improve communication, reduce errors, and enhance patient outcomes compared to traditional single-specialty approaches.
311121314Eligibility Criteria
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.Inclusion Criteria
Cardiovascular Implantable Electronic Device (CIED) in place
Presumed CIED infection, as defined by: 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. 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
I am 18 years old or older.
Exclusion 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.
Patients with left ventricular assist devices (LVADs)
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention Implementation
Multidisciplinary teams implement interventions to improve guideline-driven care for CIED infections
6 months
Prospective Data Collection
Prospective data collection starts three months after intervention and continues for 12 months
12 months
Follow-up
Participants are monitored for safety and effectiveness after intervention
4 weeks
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Atrium HealthCharlotte, NC
Northside Hospital GwinnettLawrenceville, GA
NorthwesternChicago, IL
Moses ConeGreensboro, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
Duke Clinical Research InstituteCollaborator
Philips HealthcareIndustry Sponsor
References
Healthcare-associated infection in pediatric patients on extracorporeal life support: The role of multidisciplinary surveillance. [2019]To describe the use of a multidisciplinary approach to sepsis surveillance and evaluate impact on outcome.
Evaluation of the effectiveness of an automated sepsis predictive tool on patient outcomes. [2022]To evaluate the effectiveness of a multidisciplinary, hospital-wide program as part of an electronic sepsis alert tool.
Cardiovascular outcomes initiative: case studies in performance improvement. [2019]Multidisciplinary health care teams are trying to change practice in ways that will improve patient outcomes. Three case studies are presented that demonstrate such practice changes. The practice changes involved a multidisciplinary team working toward commonly defined goals over an 18-month period. Several goals were attained, and lessons learned are presented. Nursing staff played a significant role in identifying and implementing the recommended changes.
Reducing complications in trauma patients: use of a standardized quality improvement approach. [2019]Injured patients are especially prone to developing complications. Using a multidisciplinary standardized approach to complication review is an effective method of evaluating quality improvement in patients on the trauma service. Collaboration between trauma surgeons and nurse clinicians is instrumental in improving the care of patients in each of the areas we identified. Using this consistently, quality improvement strategies can be put in place and tracked for outcomes. This has allowed for better quantification of the problem as well as any change that may result from applying this formal review process and subsequent intervention.
Critical and anticipated recovery paths: only the beginning. [2019]Multidisciplinary outcome-based care plans are a powerful aid to clinicians in managed care and case management situations. After several years of using Anticipated Recovery Paths, a committee designed a Professional Practice Symposium focusing on the skills needed by nursing personnel to provide effective outcome-based practice. Results of this educational effort are reported.
Intervention of pharmacist included in multidisciplinary team to reduce adverse drug event: a qualitative systematic review. [2023]Preventable harm in healthcare is a growing public health challenge. In addition to the economic costs of safety failures, adverse drug events (ADE) may lead to complication or even death. Multidisciplinary care team involving a pharmacist appears to be an adequate response to prevention of adverse drug event. This qualitative systematic review aims to identify and describe multidisciplinary planned team-based care involving at least one pharmacist to limit or prevent adverse drug events in the adult patients.
Examining the nature of interprofessional interventions designed to promote patient safety: a narrative review. [2022]This narrative review aimed to scope the patient safety literature to identify interprofessional intervention approaches, sources of evidence and reported outcomes.
Structured interdisciplinary rounds in a medical teaching unit: improving patient safety. [2022]Effective collaboration and teamwork is essential to providing safe hospital care. The objective of this study was to assess the effect of an intervention designed to improve interdisciplinary collaboration and lower the rate of adverse events (AEs).
Advancing Medication Safety: Establishing a National Action Plan for Adverse Drug Event Prevention. [2019]Adverse drug events (ADEs) are important contributors to preventable morbidity and mortality, comprising one third of all hospital adverse events. In response to growing evidence detailing the high prevalence of ADEs, particularly among vulnerable older adults, Congress requested that the Secretary of the Department of Health and Human Services (HHS) convene a Federal Interagency Steering Committee to establish a National Action Plan to focus on ADE prevention. In August 2014, the Office of Disease Prevention and Health Promotion released the final version of the National Action Plan for Adverse Drug Event Prevention. The Action Plan directly supports the goals of the HHS Strategic Plan and the Patient Protection and Affordable Care Act by providing guidance on tracking and preventing ADEs, as well as describing evidence-based tools and resources to enhance medication safety. ADE ACTION PLAN CONTENT: The Federal Interagency Steering Committee focused the Action Plan on ADEs that are clinically significant, account for the greatest number of measurable harms as identified by using existing surveillance tools, and are largely preventable. As such, the decision was made to target three medication classes: anticoagulants, diabetes agents (insulin and oral hypoglycemic agents), and opioids. The Action Plan is organized around four key areas: surveillance; evidence-based prevention; payment, policy incentives, and oversight; and research opportunities to advance medication safety.
Multidisciplinary in-hospital teams improve patient outcomes: A review. [2022]The use of multidisciplinary in-hospital teams limits adverse events (AE), improves outcomes, and adds to patient and employee satisfaction.
A Quality Improvement Initiative: Developing a Multi-Disciplinary Team for Infective Endocarditis. [2023]As guidelines do not describe how to develop a multi-disciplinary team(MDT), we provide a model using quality improvement tools to design a MDT for infective endocarditis (IE).
Multidisciplinary achievement: the collaborative approach to rapid cycle ICU and hospital change. [2019]Multidisciplinary teams are different from the traditional team format in that representation and participation from various disciplines characterize the structure. In April 1996, a multidisciplinary group from Muhlenberg Regional Medical Center's intensive care unit learned methodology at the Institute for Health Care Improvement (IHI) Breakthrough Series in Adult Intensive Care. With the format learned, improvements in diverse areas such as ventilator management, intermediate care, clinical laboratory utilization, and others were accomplished. Continued support from an expert staff and utilization of on-line communication tools characterized this 15-month quality improvement endeavor. The end of the breakthrough series spurred the development of a hospital-wide collaborative cost containment team.
The Menefee model for patient-focused interdisciplinary team collaboration. [2022]The conversion to electronic plans of care in a community hospital setting offered an opportunity to design an interdisciplinary, collaborative model for patient-focused care. The performance improvement initiative began with the development of evidence-based interdisciplinary plans of care and concluded with a consistent and effective process for patient engagement and daily interdisciplinary team rounding. Benefits include reduced readmission rates, higher patient satisfaction, and improved interdisciplinary team collaboration. This project demonstrates how an interdisciplinary model that includes patient-centered, nurse-led care plan rounding was created, implemented, and measured.
Physician perceptions of a multidisciplinary endocarditis team. [2020]Infectious endocarditis is a highly morbid infection that requires coordination of care across medical and surgical specialties, often through the use of a multidisciplinary team model. Multiple studies have demonstrated that such conferences can improve clinical outcomes. However, little is known about physicians' impressions of these groups. We surveyed 126 (response rate of 30%) internal medicine, infectious diseases, cardiology, and cardiac surgery providers 1 year after the implementation of an endocarditis team at the University of Michigan. Ninety-eight percent of physicians felt that the endocarditis team improved communication between specialties. Additionally, over 85% of respondents agreed that the group influenced diagnostic evaluation, reduced management errors, increased access to surgery, and decreased in-hospital mortality for endocarditis patients. These results suggest that multidisciplinary endocarditis teams are valued by physicians as a tool to improve patient care and serve an important role in increasing communication between providers.