Clinical trial NCT02402257: Central Venous Catheter Insertion Train the Trainer
Official title: Dissemination of a Simulation-based Mastery Learning Curriculum for Central Venous Catheter Insertion at Veterans Affairs Hospitals: A Quantitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Central Venous Catheter
Simulation-based Mastery Learning
Medical Education
Patient Outcomes
Bloodstream Infection Due to Central Venous Catheter
Pneumothorax
Inadvertent Arterial Puncture
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Medical Error Reduction and Certification, Inc.
First posted: 2015-03-30
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Trainees undergoing simulation-based mastery learning for CVC insertion
2. De-identified patient information from patients with a CVC.

Brief summary: The investigators previously successfully implemented a central venous catheter (CVC) simulation-based mastery learning (SBML) curriculum at Northwestern University. As a result, trainee skill improved, complications, including central line associated bloodstream infections (CLABSIs) decreased and the curriculum was proven cost-effective. Therefore the Veterans Administration Medical Centers (VAMC) decided to implement this training at some of their sites as a quality improvement project. The investigators will train faculty at these locations to implement the same curriculum at their individual sites. Outcome data will be collected to evaluate the outcomes of the quality improvement (QI) project (complications, infections, skills).

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.

Eligibility criteria: Inclusion Criteria:

1. Previously (or prospectively) collected de-identified data on trainee skill and experience
2. Previously (or prospectively) collected de-identified data on patients in the VA ICU with CVCs
3. Previously (or prospectively) collected de-identified data on mechanical complications in the ICUs

Exclusion Criteria:

1. Data not de-identified
2. Data on pts on non-ICU units
3. Data on pts without CVCs

Primary outcomes:
measure: The effectiveness of simulation based mastery learning for CVC insertion on CLABSIs
timeFrame: 3 years
Secondary outcomes:
measure: The effectiveness of simulation based mastery learning for CVC insertion on mechanical complications
timeFrame: 3 years
measure: The effectiveness simulation based mastery learning for CVC insertion at the learner level using simulated checklist data and trainee surveys
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jeffrey H Barsuk, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.