- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02402257
Central Venous Catheter Insertion Train the Trainer
Dissemination of a Simulation-based Mastery Learning Curriculum for Central Venous Catheter Insertion at Veterans Affairs Hospitals: A Quantitative Study
Study Overview
Detailed Description
Beginning in 2006, Northwestern University Internal Medicine and Emergency Medicine residents completed simulation-based mastery learning in central venous catheter (CVC) insertion before clinical rotations in the Medical Intensive Care Unit (MICU). This comprehensive program in central line training used repetitive practice and simulation technology to train residents to mastery standards. This study had important patient safety implications. This program resulted in improved trainee skill and reduced CVC insertion complications, including a significant decrease in the rate of central line associated bloodstream infections (CLABSI). In addition, the investigators showed that the in CVC insertion was highly cost-effective suggesting that investment in simulation training can produce significant medical care cost savings.
This curriculum has now been successfully implemented at a few other sites. Due to the investigators' success, the VA has requested that Medical Error Reduction and Certification, Inc.(MERCI) along with Northwestern University, implements the curriculum at its sites across the county as a quality improvement project. Using a train the trainer course in CVC placement, the investigators are interested in analyzing the data that the VAMC will provide to MERCI and studying the outcomes.
Four Northwestern faculty completed a CVC insertion Master trainer curriculum. One master trainer travels to each VA facility in the program to facilitate a two-day train-the-trainer course on CVC insertion SBML. Each VA facility selects one or two "faculty champions" who complete CVC insertion SBML course and learn how to teach the curriculum on day 1 and are observed training and assessing peer healthcare providers at their institution on day 2. Course materials include standardized videos and lectures, role-playing and practice with sample learners and CVC insertion assessments. In addition to the onsite master trainer, each VA facility receives necessary training materials (standardized video lectures, data collection forms, assessment tools) and equipment (CentralLineMan simulators, ultrasound) to implement the curriculum at their institution. All participants complete pre and post testing and a course evaluation questionnaire. Quantitative outcome data on learner skills and CVC insertion quality measures are collected to measure the overall success of the project.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Trainees undergoing simulation-based mastery learning for CVC insertion
- De-identified patient information from patients with a CVC.
Description
Inclusion Criteria:
- Previously (or prospectively) collected de-identified data on trainee skill and experience
- Previously (or prospectively) collected de-identified data on patients in the VA ICU with CVCs
- Previously (or prospectively) collected de-identified data on mechanical complications in the ICUs
Exclusion Criteria:
- Data not de-identified
- Data on pts on non-ICU units
- Data on pts without CVCs
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Traditionally-trained
Patients who undergo CVC procedures by traditionally-trained providers who have not undergone simulation-based mastery learning.
This could be retrospective (before the study started) or at a site where the training was not implemented.
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|
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CVC Train the Trainer
Patients who undergo CVC procedures by providers who have participated in simulation-based mastery learning.
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Trainees receive a simulation-based mastery learning intervention and train-the-trainer program on central venous catheter insertion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The effectiveness of simulation based mastery learning for CVC insertion on CLABSIs
Time Frame: 3 years
|
Data from infection control on central line associated bloodstream infections will be reported for all sites each month.
The investigators plan to compare the trained ICU's infection rates with other ICUs at other sites in addition to comparing the trained period versus the untrained period while trainees were rotating through the MICU.
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The effectiveness of simulation based mastery learning for CVC insertion on mechanical complications
Time Frame: 3 years
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ICUs will collect information on actual CVC insertions including complications (need for line adjustment, arterial puncture, pneumothorax).
The investigators plan to compare the trained ICU's complication rates with other ICUs at other sites in addition to comparing the trained period versus the untrained period while trainees were rotating through the MICU.
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3 years
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The effectiveness simulation based mastery learning for CVC insertion at the learner level using simulated checklist data and trainee surveys
Time Frame: 2 years
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Using simulated checklist data and trainee surveys, the investigators will assess the effectiveness of our intervention at the learner level.
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2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeffrey H Barsuk, MD, MS, Northwestern University
Publications and helpful links
General Publications
- Barsuk JH, Cohen ER, Feinglass J, McGaghie WC, Wayne DB. Use of simulation-based education to reduce catheter-related bloodstream infections. Arch Intern Med. 2009 Aug 10;169(15):1420-3. doi: 10.1001/archinternmed.2009.215.
- Barsuk JH, McGaghie WC, Cohen ER, O'Leary KJ, Wayne DB. Simulation-based mastery learning reduces complications during central venous catheter insertion in a medical intensive care unit. Crit Care Med. 2009 Oct;37(10):2697-701.
- Barsuk JH, Cohen ER, Potts S, Demo H, Gupta S, Feinglass J, McGaghie WC, Wayne DB. Dissemination of a simulation-based mastery learning intervention reduces central line-associated bloodstream infections. BMJ Qual Saf. 2014 Sep;23(9):749-56. doi: 10.1136/bmjqs-2013-002665. Epub 2014 Mar 14.
- Barsuk JH, McGaghie WC, Cohen ER, Balachandran JS, Wayne DB. Use of simulation-based mastery learning to improve the quality of central venous catheter placement in a medical intensive care unit. J Hosp Med. 2009 Sep;4(7):397-403. doi: 10.1002/jhm.468.
- Cohen ER, Feinglass J, Barsuk JH, Barnard C, O'Donnell A, McGaghie WC, Wayne DB. Cost savings from reduced catheter-related bloodstream infection after simulation-based education for residents in a medical intensive care unit. Simul Healthc. 2010 Apr;5(2):98-102. doi: 10.1097/SIH.0b013e3181bc8304.
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
Other Study ID Numbers
- STU00089190
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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