Cardiovascular DiseaseNCT02073760
Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery (HAI)_2
An observational study of Cardiovascular Disease and Healthcare Associated Infectious Disease, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Healthcare Associated Infectious Disease, Sternal Superficial Wound Infection
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 29 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clinical providers and administrators working at any of 33 institutions performing cardiac surgery in the state of Michigan
Who may be able to join
- Clinical providers or
- Administrators
- Must work at any of 33 institutions performing cardiac surgery in the state of Michigan
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cardiovascular Disease, Healthcare Associated Infectious Disease, Sternal Superficial Wound Infection, Deep Sternal Infection, Mediastinitis, Thoracotomy
- Being tested
- There is no intervention. The investigators are interviewing cardiac surgery staff with knowledge of infection prevention.
- Keywords
- Healthcare acquired infections, Cardiac Surgery, Sternal Superficial Wound Infection, Deep Sternal Infection, Mediastinitis, Thoracotomy, Conduit harvest or cannulation site, Sepsis, Pneumonia
- Medical subject headings
- Cardiovascular Diseases, Cross Infection, Mediastinitis, Sepsis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention. The investigators are interviewing cardiac surgery staff with knowledge of infection prevention.Other
Also called Caregivers
The investigators will conduct tape recorded interviews with hospital staff about infection prevention.
| Study group | Role | What they receive |
|---|---|---|
| Infection Prevention Experts | Adult caregivers of cardiac surgery patients (e.g. surgeons, nurses, infection preventionists) and administrators Receives: Other: There is no intervention. The investigators are interviewing cardiac surgery staff with knowledge of infection prevention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventive Strategies
Preventive strategies currently being conducted at their institution to prevent healthcare-acquired infections.
Measured: During the time of the interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startJun 2014
- Primary completion29 Sep 2018
- Study completion29 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Dr. Donald Likosky, University of Michigan
- Investigators
- Donald S Likosky, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073760
- Sponsor's protocol ID
- HAI_Umich_2
- Other IDs
- 2004-0428
- Status last verified
- Oct 2018
- First submitted
- 21 Feb 2014
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Only upon invitation and in accordance with our contractual obligations
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery (HAI)_2
- ClinicalTrials.gov ID
- NCT02073760
- Acronym / sponsor ID
- HAI_Umich_2
- Conditions
- Cardiovascular Disease, Healthcare Associated Infectious Disease, Sternal Superficial Wound Infection, Deep Sternal Infection, Mediastinitis, Thoracotomy
- Keywords
- Healthcare acquired infections, Cardiac Surgery, Sternal Superficial Wound Infection, Deep Sternal Infection, Mediastinitis, Thoracotomy, Conduit harvest or cannulation site, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jun 2014
- Primary completion
- 29 Sep 2018 (actual)
- Study completion
- 29 Sep 2018 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infection Prevention Experts | – | Other: There is no intervention. The investigators are interviewing cardiac surgery staff with knowledge of infection prevention.Adult caregivers of cardiac surgery patients (e.g. surgeons, nurses, infection preventionists) and administrators |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical providers and administrators working at any of 33 institutions performing cardiac surgery in the state of Michigan
Key inclusion criteria (3 listed)
- Clinical providers or
- Administrators
- Must work at any of 33 institutions performing cardiac surgery in the state of Michigan
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention. The investigators are interviewing cardiac surgery staff with knowledge of infection prevention.Also: CaregiversThe investigators will conduct tape recorded interviews with hospital staff about infection prevention. | Other | Infection Prevention Experts |
Primary outcome
Preventive Strategies
Time frame: During the time of the interview
Preventive strategies currently being conducted at their institution to prevent healthcare-acquired infections.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Background: PubMed 26209489Likosky 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.
- Individual participant dataSharing planned: Yes. Only upon invitation and in accordance with our contractual obligations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald S Likosky, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Healthcare Associated Infectious Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preventive Strategies (time frame: During the time of the interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02073760, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.