NCT02402257

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

4.9 years

First QC Date

March 25, 2015

Last Update Submit

September 5, 2019

Conditions

Keywords

Central Venous CatheterSimulation-based Mastery LearningMedical EducationPatient OutcomesBloodstream Infection Due to Central Venous CatheterPneumothoraxInadvertent Arterial Puncture

Outcome Measures

Primary Outcomes (1)

  • The effectiveness of simulation based mastery learning for CVC insertion on CLABSIs

    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.

    3 years

Secondary Outcomes (2)

  • The effectiveness of simulation based mastery learning for CVC insertion on mechanical complications

    3 years

  • The effectiveness simulation based mastery learning for CVC insertion at the learner level using simulated checklist data and trainee surveys

    2 years

Study Arms (2)

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.

CVC Train the Trainer

Patients who undergo CVC procedures by providers who have participated in simulation-based mastery learning.

Behavioral: CVC Train the Trainer

Interventions

Trainees receive a simulation-based mastery learning intervention and train-the-trainer program on central venous catheter insertion

CVC Train the Trainer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Trainees undergoing simulation-based mastery learning for CVC insertion 2. De-identified patient information from patients with a CVC.

You may qualify if:

  • 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

You may not qualify if:

  • Data not de-identified
  • Data on pts on non-ICU units
  • Data on pts without CVCs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

  • 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.

    PMID: 19667306BACKGROUND
  • 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.

    PMID: 19885989BACKGROUND
  • 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.

    PMID: 19753568BACKGROUND
  • 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.

    PMID: 20389233BACKGROUND
  • 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.

    PMID: 24632995BACKGROUND

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Jeffrey H Barsuk, MD, MS

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Director of Simulation and Patient Safety

Study Record Dates

First Submitted

March 25, 2015

First Posted

March 30, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations