Improving Patient Safety Through Simulation Research

NCT02097498 | Completed

• 1 other identifier: 2013H0226
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Management Assessment

Keywords

Simulation; Enhance; Safety; Proficiency; Paramedics.; Airway Management; Intubation

Outcome Measures

Primary Outcomes (1)

• Development and validation of an airway management assessment tool

  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.

  3 years

Secondary Outcomes (1)

• Development of educational interventions to improve skill retention

  2 years

Study Arms (3)

Simulation only

NO INTERVENTION

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

Directed feedback

EXPERIMENTAL

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.

Other: Directed feedback

Basic Videolaryngoscopy

EXPERIMENTAL

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.

Other: Basic Videolaryngoscopy Videos

Interventions

Directed feedback OTHER

Group will receive feedback from an airway management expert while the paramedic review their baseline simulation scenario through recorded video

Directed feedback

Basic Videolaryngoscopy Videos OTHER

Group will watch a series of educational videos related to common airway management errors.

Basic Videolaryngoscopy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently certified central Ohio paramedics

You may not qualify if:

• Refusal to participate
• Non-certified paramedics

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Study Officials

• Thomas E Terndrup, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Emergency Medicine

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: March 27, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2016
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

US (1)