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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02073760
Other study ID # HAI_Umich_2
Secondary ID 2004-0428
Status Completed
Phase
First received
Last updated
Start date June 2014
Est. completion date September 29, 2018

Study information

Verified date October 2018
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date September 29, 2018
Est. primary completion date September 29, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Mstcvs-Qc Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Likosky DS, Paone G, Zhang M, Rogers MA, Harrington SD, Theurer PF, DeLucia A 3rd, Fishstrom A, Camaj A, Prager RL; Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative. Red Blood Cell Transfusions Impact Pneumonia Rates After Coronary Artery Bypass Grafting. Ann Thorac Surg. 2015 Sep;100(3):794-800; discussion 801. doi: 10.1016/j.athoracsur.2015.03.089. Epub 2015 Jul 21. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Preventive Strategies Preventive strategies currently being conducted at their institution to prevent healthcare-acquired infections. During the time of the interview
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