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

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{3 11 12 13 14}

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.

Research Team

Chris Granger, MD

Principal Investigator

Duke Clinical Research Institute

Sean Pokorney, MD

Principal Investigator

Duke Clinical Research Institute

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Healthcare-associated infection in pediatric patients on extracorporeal life support: The role of multidisciplinary surveillance. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the effectiveness of an automated sepsis predictive tool on patient outcomes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Reducing complications in trauma patients: use of a standardized quality improvement approach. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Critical and anticipated recovery paths: only the beginning. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Intervention of pharmacist included in multidisciplinary team to reduce adverse drug event: a qualitative systematic review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Examining the nature of interprofessional interventions designed to promote patient safety: a narrative review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Structured interdisciplinary rounds in a medical teaching unit: improving patient safety. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Advancing Medication Safety: Establishing a National Action Plan for Adverse Drug Event Prevention. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

A Quality Improvement Initiative: Developing a Multi-Disciplinary Team for Infective Endocarditis. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Multidisciplinary achievement: the collaborative approach to rapid cycle ICU and hospital change. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

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

14. Germany pubmed.ncbi.nlm.nih.gov

Physician perceptions of a multidisciplinary endocarditis team. [2020]