Improving Patient Safety Through Simulation Research

Overview

The overall objective of the present proposal is to assess whether medical simulation can enhance the safety and proficiency profile of paramedics performing prehospital endotracheal intubation, and whether feedback from an airway management expert observing the simulation enhances skill retention after 12 and 24 months. Since no validated proficiency assessment tool currently exists to measure the skill of paramedics in airway management, one will be developed and tested. Using this tool, 250 paramedics in central Ohio, will undergo simulation training similar to that required for certification. A baseline assessment of proficiency will be obtained. One group will be randomized to receive simulation training similar to that required for certification, while the other group will receive feedback from an airway management expert linked to the simulation test site via a 2-way audio-video feed. Both groups of paramedics will be reassessed at 12, and 24 months to determine whether skill level was maintained or whether skills deteriorated, and whether expert intervention had any impact on skill retention.

Full Title of Study: “Improving Patient Safety Through Simulation Research: Airway Management Proficiency Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2015

Interventions

  • Other: Directed feedback
    • Group will receive feedback from an airway management expert while the paramedic review their baseline simulation scenario through recorded video
  • Other: Basic Videolaryngoscopy Videos
    • Group will watch a series of educational videos related to common airway management errors.

Arms, Groups and Cohorts

  • No Intervention: Simulation only
    • One group will be randomized to receive simulation training similar to that required for certification. Paramedics in this group will then complete a second simulation scenario
  • Experimental: Directed feedback
    • One group will review their baseline simulation scenario with a member of the research staff while providing specific feedback for errors made during the first simulation. Paramedics in this group will then complete a second simulation scenario.
  • Experimental: Basic Videolaryngoscopy
    • One group will review a series of instructional videos related to common airway management errors. Paramedics in this group will then complete a second simulation scenario.

Clinical Trial Outcome Measures

Primary Measures

  • Development and validation of an airway management assessment tool
    • Time Frame: 3 years
    • Employing a team of psychometric, human factors, and airway management experts, we propose to make refinements to our assessment tool so that it has objective measurement criteria, takes timing and sequencing of actions into account, provides reproducible scores, has high inter-rater reliability, and can be a valid measure of paramedic airway management proficiency and safety.

Secondary Measures

  • Development of educational interventions to improve skill retention
    • Time Frame: 2 years
    • The paramedics will be reassessed at 12 to determine whether skill level was maintained.

Participating in This Clinical Trial

Inclusion Criteria

  • Currently certified central Ohio paramedics Exclusion Criteria:

  • Refusal to participate – Non-certified paramedics

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ohio State University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Thomas E. Terndrup, Chair, Department of Emergency Medicine – Ohio State University
  • Overall Official(s)
    • Thomas E Terndrup, MD, Principal Investigator, The Ohio State University Wexner Medical Center

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