Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery (HAI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Michigan
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Donald Likosky, University of Michigan
ClinicalTrials.gov Identifier:
NCT02068716
First received: February 19, 2014
Last updated: July 21, 2014
Last verified: June 2014
  Purpose

Our Aim is to identify patient risk factors and clinical practices associated with healthcare-acquired infections (HAIs) after cardiac surgery.

We will use prospectively collected data housed within the MSTCVS-QC (Michigan Society of Thoracic & Cardiovascular Surgeons Quality Collaborative) to reveal risk factors that elevate a patient's risk of developing HAIs. The results of this analysis will form the foundation for the development of standardized regional practices to reduce HAIs. We will explore the effect of traditional patient-level measures (age, sex, comorbid conditions), process measures (timing and selection of antibiotics, continuous insulin infusion, transfusions), and surgical practices (use of bilateral internal mammary artery usage among diabetics, vein harvesting approach).


Condition
Healthcare Associated Infectious Disease
Sternal Superficial Wound Infection
Sepsis
Pneumonia
Deep Sternal Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Percent of patients having a healthcare-acquired infection (HAIs) post cardiac surgery. [ Time Frame: In-hospital or within the first 30 days (for surgical infections) after surgery ] [ Designated as safety issue: Yes ]
    Overall HAIs include pneumonia, sepsis/septicemia, and surgical site infections, including deep sternal wound, thoracotomy, and harvest/cannulation site infections.


Estimated Enrollment: 13925
Study Start Date: March 2014
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adults with HAIs

Adult cardiac surgery patients who develop infections in hospitals within 30 days post surgery.

We will exclude patients presenting with endocarditis.


Detailed Description:

More than 400,000 coronary artery bypass grafting (CABG) procedures are performed every year in the United States (U.S.). Patients undergoing CABG surgery are at risk for a number of adverse sequelae, many of which impact survival and contribute to overall health-care costs. Healthcare-acquired infections (HAIs), including pneumonia and superficial and deep sternal wound infections, occur among 16% of CABG patients and elevate a patient's risk of mortality and add excess upfront and long-term expenditures to the health care system.

A number of barriers prevent wide-scale improvements in HAl rates within the setting of CABG surgery. While a number of HAl prophylaxis measures have been developed, these measures do not fully encompass the set of practices that may impact a patient's risk of HAl. Identifying cardiac surgery specific risk factors would serve as the foundation for targeted quality improvement strategies. In the absence of definitive data concerning best practices, HAl prophylaxis is variable across surgeons and institutions, resulting in unnecessary morbidity and cost. Prior work has shown the value of implementing evidence-based protocols in the general intensive care unit setting. To what extent the implementation of cardiac surgery specific standardized practices results in lower HAl rates is uncertain. An understanding of the effectiveness of this approach would certainly assist surgeons and institutions in providing safer care to their patient populations.

Rates of HAIs vary from 0-26% across the 33 institutions performing CABG surgery in Michigan. This application seeks to reduce this rate by identifying and subsequently implementing standardized practices, and evaluating their impact on HAl rates. This study will be based on the prospective data and regional quality improvement activities and infrastructure of the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative (MSTCVS-QC). We will evaluate the effectiveness of these standardized practices in reducing HAIs regionally and relative to national rates during the same time period.

Our Aim is to identify patient risk factors and clinical practices associated with HAIs after cardiac surgery.

We will use prospectively collected data housed within the MSTCVS-QC to reveal risk factors that elevate a patient's risk of developing HAIs. The results of this analysis will form the foundation for the development of standardized regional practices to reduce HAIs. We will explore the effect of traditional patient-level measures (age, sex, comorbid conditions), process measures (timing and selection of antibiotics, continuous insulin infusion, transfusions), and surgical practices (use of bilateral internal mammary artery usage among diabetics, vein harvesting approach).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing adult cardiac surgery

Criteria

Inclusion Criteria:

  • Female and male adult patients 18 and over undergoing cardiac surgery within the state of Michigan from January 1, 2011 through June 30, 2013.

Exclusion Criteria:

  • Pregnant women,
  • children,
  • endocarditis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068716

Contacts
Contact: Astrid Fishstrom, LMSW (734) 998-7291 astridf@med.umich.edu

Locations
United States, Michigan
Mstcvs-Qc Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Astrid B Fishstrom, MSW    734-998-7291    astridf@umich.edu   
Contact: Patty Theurer, RN, BSN    (734) 998-5918    ptheurer@med.umich.edu   
Principal Investigator: Donald Likosky, PhD         
Sponsors and Collaborators
Dr. Donald Likosky
Investigators
Principal Investigator: Donald S Likosky, Ph.D. University of Michigan
  More Information

Publications:
Responsible Party: Dr. Donald Likosky, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02068716     History of Changes
Other Study ID Numbers: HAI_Umich, 2004-0428
Study First Received: February 19, 2014
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Healthcare acquired infections
Cardiovascular Surgery
Mediastinitis
Thoracotomy
Conduit harvest or cannulation site

Additional relevant MeSH terms:
Communicable Diseases
Infection
Pneumonia
Sepsis
Wound Infection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on July 29, 2014