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CompletedNCT02073760Updated Oct 22, 2018

Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery (HAI)_2

An observational study in Cardiovascular Disease, Healthcare Associated Infectious Disease and Sternal Superficial Wound Infection, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-22.

Sponsored by University of Michigan · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
79
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular Disease
  • Healthcare Associated Infectious Disease
  • Sternal Superficial Wound Infection
  • Deep Sternal Infection
  • Mediastinitis
  • Thoracotomy
  • Conduit Harvest or Cannulation Site
  • Sepsis
  • Pneumonia

Keywords

  • Healthcare acquired infections
  • Cardiac Surgery
  • Sternal Superficial Wound Infection
  • Deep Sternal Infection
  • Mediastinitis
  • Thoracotomy
  • Conduit harvest or cannulation site
  • Sepsis
  • Pneumonia
03

In context

Cardiovascular Diseases

5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.

This study's enrollment of 79 is below the median of 506 across 1,572 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Clinical providers and administrators working at any of 33 institutions performing cardiac surgery in the state of Michigan

Eligibility criteria

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

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
79 participants (actual)
Patient registry
No

Groups and cohorts

  • Infection Prevention Experts

    Adult caregivers of cardiac surgery patients (e.g. surgeons, nurses, infection preventionists) and administrators

    Other: There is no intervention. The investigators are interviewing cardiac surgery staff with knowledge of infection prevention.

Interventions

  • OtherThere 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.

    Also known as: Caregivers

06

What researchers measure

Primary outcomes

  1. Preventive Strategies

    Preventive strategies currently being conducted at their institution to prevent healthcare-acquired infections.

    Time frame: During the time of the interview

07

Study locations

1 site
  • Mstcvs-Qc
    Ann Arbor, Michigan 48105, United States
08

References and documents

Publications

  • 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. PubMed 26209489 ↗

Individual participant data

Plan to share: Yes — Only upon invitation and in accordance with our contractual obligations

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02073760
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Responsible party
Dr. Donald Likosky (Associate Professor, University of Michigan) — Principal investigator
First posted
Feb 27, 2014
Start date
Jun 2014
Primary completion
Sep 29, 2018
Completion
Sep 29, 2018
Last update
Oct 22, 2018

Study contacts

Donald S Likosky, Ph.D.
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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