Overview

This trial is active, not recruiting.

Conditions healthcare associated infectious disease, sternal superficial wound infection, sepsis, pneumonia, deep sternal infection
Sponsor Dr. Donald Likosky
Collaborator Agency for Healthcare Research and Quality (AHRQ)
Start date March 2014
End date October 2017
Trial size 13925 participants
Trial identifier NCT02068716, 2004-0428, HAI_Umich

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Adult cardiac surgery patients who develop infections in hospitals within 30 days post surgery. We will exclude patients presenting with endocarditis.

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery
Principal investigator Donald S Likosky, Ph.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Michigan.