Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery

NCT ID: NCT02068716

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 911754 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-09-29

Brief 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).

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).

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Adults with HAIs

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

We will exclude patients presenting with endocarditis.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Dr. Donald Likosky

OTHER

Sponsor Role: lead

Responsible Party

Dr. Donald Likosky

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Donald S Likosky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Mstcvs-Qc

Ann Arbor, Michigan, United States

Countries

United States

References

Shih T, Zhang M, Kommareddi M, Boeve TJ, Harrington SD, Holmes RJ, Roth G, Theurer PF, Prager RL, Likosky DS; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Center-level variation in infection rates after coronary artery bypass grafting. Circ Cardiovasc Qual Outcomes. 2014 Jul;7(4):567-73. doi: 10.1161/CIRCOUTCOMES.113.000770. Epub 2014 Jul 1.

Reference Type: RESULT

PMID: 24987052 (View on PubMed)

Likosky DS, Wallace AS, Prager RL, Jacobs JP, Zhang M, Harrington SD, Saha-Chaudhuri P, Theurer PF, Fishstrom A, Dokholyan RS, Shahian DM, Rankin JS; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Sources of Variation in Hospital-Level Infection Rates After Coronary Artery Bypass Grafting: An Analysis of The Society of Thoracic Surgeons Adult Heart Surgery Database. Ann Thorac Surg. 2015 Nov;100(5):1570-5; discussion 1575-6. doi: 10.1016/j.athoracsur.2015.05.015. Epub 2015 Aug 28.

Reference Type: RESULT

PMID: 26321440 (View on PubMed)

Strobel RJ, Liang Q, Zhang M, Wu X, Rogers MA, Theurer PF, Fishstrom AB, Harrington SD, DeLucia A 3rd, Paone G, Patel HJ, Prager RL, Likosky DS; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. A Preoperative Risk Model for Postoperative Pneumonia After Coronary Artery Bypass Grafting. Ann Thorac Surg. 2016 Oct;102(4):1213-9. doi: 10.1016/j.athoracsur.2016.03.074. Epub 2016 Jun 1.

Reference Type: RESULT

PMID: 27261082 (View on PubMed)

Brescia AA, Rankin JS, Cyr DD, Jacobs JP, Prager RL, Zhang M, Matsouaka RA, Harrington SD, Dokholyan RS, Bolling SF, Fishstrom A, Pasquali SK, Shahian DM, Likosky DS; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Determinants of Variation in Pneumonia Rates After Coronary Artery Bypass Grafting. Ann Thorac Surg. 2018 Feb;105(2):513-520. doi: 10.1016/j.athoracsur.2017.08.012. Epub 2017 Nov 23.

Reference Type: RESULT

PMID: 29174785 (View on PubMed)

Likosky DS, Harrington SD, Cabrera L, DeLucia A 3rd, Chenoweth CE, Krein SL, Thibault D, Zhang M, Matsouaka RA, Strobel RJ, Prager RL. Collaborative Quality Improvement Reduces Postoperative Pneumonia After Isolated Coronary Artery Bypass Grafting Surgery. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004756. doi: 10.1161/CIRCOUTCOMES.118.004756.

Reference Type: DERIVED

PMID: 30571334 (View on PubMed)

Other Identifiers

2004-0428

Identifier Type: OTHER

Identifier Source: secondary_id

HAI_Umich

Identifier Type: -

Identifier Source: org_study_id