Multidisciplinary Care Program for CIED Infections

(RECTIFY Trial)

Recruiting at 3 trial locations

Overseen By Kimberly Ward, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Inappropriate for extraction, Death within week, LVADs

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance care for individuals with infections related to cardiovascular implantable electronic devices (CIEDs). The research focuses on developing a model to help doctors quickly and effectively identify and treat these infections. By employing a multidisciplinary team approach, the trial ensures patients receive optimal care according to existing guidelines. It includes a program that adjusts healthcare practices based on ongoing feedback and results. Individuals with a CIED who suspect an infection, such as redness or swelling near the device, may be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to innovative healthcare solutions and improve future treatment strategies.

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 prior data suggests that this program is safe for patients with CIED infections?

Research has shown that using a team of diverse healthcare experts to manage infections from heart device implants is effective. One study found that involving various specialists improved treatment for patients with suspected infections in these devices. This team approach not only identified infections early but also accelerated the treatment process. Importantly, no major reports have linked negative effects directly to this team-based method. Overall, evidence suggests that this approach is safe and well-tolerated for managing infections in heart device implants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multidisciplinary Care Program for CIED infections because it takes a comprehensive approach to tackling the issue. Unlike traditional treatments that focus solely on medical interventions, this program integrates a team-based strategy, involving specialists from various fields to address the gaps in recognizing and treating CIED infections. By customizing and continuously refining patient care pathways, the program aims to overcome barriers in current treatment processes, potentially leading to more effective and timely care. This collaborative and adaptive approach could significantly improve patient outcomes compared to existing standard care options.

What evidence suggests that this program is effective for CIED infections?

Research has shown that a team of diverse healthcare experts can effectively manage infections related to heart devices. In studies, patients under the care of these teams experienced better outcomes, including quicker treatment and faster recovery. This trial will include participants in a Quality Improvement Program that uses a multidisciplinary team approach. These teams collaborate to provide comprehensive care, allowing them to detect infections sooner and recommend the best treatments. This approach ensures patients receive timely and appropriate care, which is crucial for managing these serious infections. ^{1 3 4 5 6}

Who Is on the Research Team?

Chris Granger, MD

Principal Investigator

Duke Clinical Research Institute

Sean Pokorney, MD

Principal Investigator

Duke Clinical Research Institute

Are You a Good Fit for This Trial?

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

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Measurement and Feedback
• Multidisciplinary Team
• Multifaceted Intervention
• Outreach Visits

Trial Overview 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.

How Is the Trial Designed?

Group I: Quality Improvement Program Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Duke Clinical Research Institute

Collaborator

Trials

69

Recruited

242,000+

Philips Healthcare

Industry Sponsor

Trials

127

Recruited

200,000+

Roy Jakobs

Philips Healthcare

Chief Executive Officer since 2022

Master's in Business Administration from Radboud University Nijmegen and Università degli Studi di Bologna

Dr. Roy Jakobs

Philips Healthcare

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Out of 82 infective endocarditis (IE) cases studied in 2016, only 29 met the criteria for analysis, highlighting the need for better identification and management of IE patients.

A multi-disciplinary team (MDT) was created to address the issue of left-sided IE patients not receiving indicated surgery, aiming to improve outcomes and reduce missed opportunities for surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Quality Improvement Initiative: Developing a Multi-Disciplinary Team for Infective Endocarditis. Regunath, H., Vasudevan, A., Vyas, K., et al.[2023]

A multidisciplinary health care team worked together over 18 months to implement practice changes aimed at improving patient outcomes, demonstrating the effectiveness of collaborative efforts in healthcare.

Nursing staff were crucial in both identifying the necessary changes and putting them into action, highlighting the importance of their role in enhancing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular outcomes initiative: case studies in performance improvement. Duffy, JR.[2019]

A survey of 126 healthcare providers at the University of Michigan revealed that 98% felt the multidisciplinary endocarditis team improved communication between specialties, highlighting its importance in patient care.

Over 85% of respondents agreed that the team positively influenced diagnostic evaluations, reduced management errors, increased access to surgery, and decreased in-hospital mortality for patients with infectious endocarditis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician perceptions of a multidisciplinary endocarditis team. El-Dalati, S., Khurana, I., Soper, N., et al.[2020]

A multidisciplinary approach to sepsis surveillance in a pediatric ECMO center led to a significant reduction in sepsis rates from 29.3 to 20.1 episodes per 1000 ECMO days after implementing new policies and practices.

Infection during ECMO support increased the odds of death, particularly in cardiac patients with open sternum, highlighting the need for targeted antibiotic prophylaxis and ongoing quality improvement efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare-associated infection in pediatric patients on extracorporeal life support: The role of multidisciplinary surveillance. Brown, KL., Ridout, DA., Shaw, M., et al.[2019]

The implementation of multidisciplinary outcome-based care plans, specifically Anticipated Recovery Paths, has proven to be a valuable tool for clinicians in managed care and case management settings.

A Professional Practice Symposium was conducted to enhance nursing skills for effective outcome-based practice, indicating a commitment to improving patient care through education and collaboration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical and anticipated recovery paths: only the beginning. Zander, K., McGill, R.[2019]

Adverse drug events (ADEs) are a major cause of preventable harm in hospitals, particularly affecting older adults, prompting the creation of a National Action Plan to enhance medication safety.

The Action Plan focuses on preventing ADEs from three high-risk medication classes: anticoagulants, diabetes agents, and opioids, and emphasizes surveillance, evidence-based prevention, and education for both healthcare providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Medication Safety: Establishing a National Action Plan for Adverse Drug Event Prevention. Harris, Y., Hu, DJ., Lee, C., et al.[2019]

A standardized multidisciplinary approach to reviewing complications in injured patients effectively enhances quality improvement in trauma care.

Collaboration between trauma surgeons and nurse clinicians is crucial for improving patient outcomes, allowing for better tracking and quantification of complications and the effectiveness of interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing complications in trauma patients: use of a standardized quality improvement approach. Reicks, P., Thorson, M., Irwin, E., et al.[2019]

A multidisciplinary program using an electronic sepsis alert tool in 15 hospitals did not significantly improve patient outcomes, including mortality and ICU stay, for adults with severe sepsis or septic shock.

The implementation of the sepsis prediction tool did not lead to a statistically significant increase in the completion of the SEP-1 care bundle or timely antibiotic administration compared to control hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the effectiveness of an automated sepsis predictive tool on patient outcomes. Schootman, M., Wiskow, C., Loux, T., et al.[2022]

The implementation of electronic plans of care in a community hospital led to a collaborative model that improved patient engagement and daily interdisciplinary team rounding.

This initiative resulted in reduced readmission rates, increased patient satisfaction, and enhanced collaboration among healthcare teams, showcasing the effectiveness of a nurse-led, patient-centered approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Menefee model for patient-focused interdisciplinary team collaboration. Menefee, KS.[2022]

The review analyzed 89 studies focused on interprofessional interventions for patient safety, primarily in North American acute care settings, highlighting the importance of collaboration among healthcare professionals, especially in nursing and medicine.

Educational interventions, like TeamSTEPPS, were commonly used to improve practitioners' skills in delivering safe care, but there is a need for more studies to evaluate the actual impact on patient safety outcomes and practitioners' behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the nature of interprofessional interventions designed to promote patient safety: a narrative review. Reeves, S., Clark, E., Lawton, S., et al.[2022]

Multidisciplinary care teams that include pharmacists are effective in preventing adverse drug events (ADEs), with the most common intervention being structured medication review meetings involving physicians, pharmacists, and nurses.

The majority of interventions targeted elderly patients, particularly those in nursing homes, highlighting the need for comprehensive medication assessments in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention of pharmacist included in multidisciplinary team to reduce adverse drug event: a qualitative systematic review. Zaij, S., Pereira Maia, K., Leguelinel-Blache, G., et al.[2023]

A multidisciplinary team from Muhlenberg Regional Medical Center's intensive care unit implemented a quality improvement initiative over 15 months, focusing on areas like ventilator management and clinical laboratory utilization, which led to significant enhancements in patient care.

The training received from the Institute for Health Care Improvement facilitated these improvements and resulted in the formation of a hospital-wide collaborative team aimed at cost containment, demonstrating the effectiveness of multidisciplinary approaches in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary achievement: the collaborative approach to rapid cycle ICU and hospital change. Besserman, E., Brennan, M., Brown, PA., et al.[2019]

The implementation of Structured Inter-Disciplinary Rounds in a medical teaching unit led to a significant reduction in adverse events (AEs), with a rate of 3.9 per 100 patient-days compared to 7.2 and 7.7 in control units, indicating improved patient safety.

Preventable AEs also decreased significantly, from 2.8 and 2.1 per 100 patient-days in control units to just 0.9 in the intervention unit, demonstrating the efficacy of structured communication in enhancing interdisciplinary collaboration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structured interdisciplinary rounds in a medical teaching unit: improving patient safety. O'Leary, KJ., Buck, R., Fligiel, HM., et al.[2022]

Multidisciplinary in-hospital teams significantly reduce adverse events and improve patient outcomes by enhancing communication and teamwork among healthcare workers, as shown in various settings like emergency rooms and operating rooms.

These teams not only maximize patient safety and satisfaction but also decrease the length of hospital stays and improve job satisfaction for healthcare workers, highlighting the importance of maintaining cohesive teams in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary in-hospital teams improve patient outcomes: A review. Epstein, NE.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40160346/

Management of Cardiovascular Implantable Electronic ... We report the outcomes associated with management of suspected cardiac implantable electronic device infections by a multidisciplinary team.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11949750/

Management of Cardiovascular Implantable Electronic ... We report the outcomes associated with management of suspected cardiac implantable electronic device infections by a multidisciplinary team.

3. researchgate.net researchgate.net/publication/389712576_Management_of_Cardiovascular_Implantable_Electronic_Device_Infection_Utilizing_a_Multidisciplinary_Team_A_Retrospective_Cohort_Study

Management of Cardiovascular Implantable Electronic ... We report the outcomes associated with management of suspected cardiac implantable electronic device infections by a multidisciplinary team. Methods Patient ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001264

Periprocedural Management and Multidisciplinary Care ... CIED indicates cardiac implantable electronic devices. Understanding and managing CIEDs are of utmost importance because interference with ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1050173825000210

Cardiac implantable electronic device infection Cardiac implantable electronic device infections (CIEDI) are a serious complication associated with significant morbidity, mortality, and cost to the healthcare ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001187

Update on Cardiovascular Implantable Electronic Device ... Among 19 603 patients (12 842 of whom were at high risk for infection), outcomes trended in favor of the incremental strategy; however, there ...