- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02073760
Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery (HAI)_2
Study Overview
Status
Conditions
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). 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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48105
- Mstcvs-Qc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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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The investigators will conduct tape recorded interviews with hospital staff about infection prevention.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preventive Strategies
Time Frame: During the time of the interview
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Preventive strategies currently being conducted at their institution to prevent healthcare-acquired infections.
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During the time of the interview
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAI_Umich_2
- 2004-0428 (UMichigan's IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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