Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery (HAI)_2
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ClinicalTrials.gov Identifier: NCT02073760 |
Recruitment Status
:
Active, not recruiting
First Posted
: February 27, 2014
Last Update Posted
: October 26, 2017
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Condition or disease | Intervention/treatment |
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Cardiovascular Disease Healthcare Associated Infectious Disease Sternal Superficial Wound Infection Deep Sternal Infection Mediastinitis Thoracotomy Conduit Harvest or Cannulation Site Sepsis Pneumonia | Other: There is no intervention. The investigators are interviewing cardiac surgery staff with knowledge of infection prevention. |
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). The investigators will evaluate the effectiveness of these standardized practices in reducing HAIs regionally and relative to national rates during the same time period.
The investigators will conduct qualitative interviews of hospital personnel regarding HAI prevention practices, and use coded data from these interviews to assist in developing standardized practices.
Study Type : | Observational |
Estimated Enrollment : | 330 participants |
Observational Model: | Other |
Time Perspective: | Cross-Sectional |
Official Title: | Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery (HAI)_2 |
Study Start Date : | June 2014 |
Estimated Primary Completion Date : | September 2018 |
Estimated Study Completion Date : | September 2018 |
Group/Cohort | Intervention/treatment |
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Infection Prevention Experts
Adult caregivers of cardiac surgery patients (e.g. surgeons, nurses, infection preventionists) and administrators
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Other: There is no intervention. The investigators are interviewing cardiac surgery staff with knowledge of infection prevention.
The investigators will conduct tape recorded interviews with hospital staff about infection prevention.
Other Name: Caregivers
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- Preventive Strategies [ Time Frame: During the time of the interview ]Preventive strategies currently being conducted at their institution to prevent healthcare-acquired infections.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Clinical providers or
- Administrators
- Must work at any of 33 institutions performing cardiac surgery in the state of Michigan
Exclusion Criteria: Under 18 years of age

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073760
United States, Michigan | |
Mstcvs-Qc | |
Ann Arbor, Michigan, United States, 48105 |
Principal Investigator: | Donald S Likosky, Ph.D. | University of Michigan |
Publications:
Responsible Party: | Dr. Donald Likosky, Associate Professor, University of Michigan |
ClinicalTrials.gov Identifier: | NCT02073760 History of Changes |
Other Study ID Numbers: |
HAI_Umich_2 2004-0428 ( Other Identifier: UMichigan's IRB ) |
First Posted: | February 27, 2014 Key Record Dates |
Last Update Posted: | October 26, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Only upon invitation and in accordance with our contractual obligations |
Keywords provided by Dr. Donald Likosky, University of Michigan:
Healthcare acquired infections Cardiac Surgery Sternal Superficial Wound Infection Deep Sternal Infection Mediastinitis |
Thoracotomy Conduit harvest or cannulation site Sepsis Pneumonia |
Additional relevant MeSH terms:
Infection Communicable Diseases Cardiovascular Diseases Pneumonia Sepsis Wound Infection Mediastinitis Cross Infection Lung Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Mediastinal Diseases Thoracic Diseases Iatrogenic Disease Disease Attributes |