Improving Patient Safety Through Simulation Research

Sponsor

Ohio State University (Other)

Overall Status

Completed

CT.gov ID

NCT02097498

Collaborator

(none)

387

Enrollment

Location

Arms

Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Airway Management Assessment	Other: Directed feedback Other: Basic Videolaryngoscopy Videos	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

387 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Improving Patient Safety Through Simulation Research: Airway Management Proficiency Study

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

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.

Other: Directed feedback

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

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.

Other: Basic Videolaryngoscopy Videos

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

Outcome Measures

Primary Outcome Measures

Development and validation of an airway management assessment tool [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 Outcome Measures

Development of educational interventions to improve skill retention [2 years]
The paramedics will be reassessed at 12 to determine whether skill level was maintained.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Currently certified central Ohio paramedics

Exclusion Criteria:

Refusal to participate
Non-certified paramedics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator: Thomas E Terndrup, MD, The Ohio State University Wexner Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas E. Terndrup, Chair, Department of Emergency Medicine, Ohio State University

ClinicalTrials.gov Identifier:

NCT02097498

Other Study ID Numbers:

2013H0226

First Posted:

Mar 27, 2014

Last Update Posted:

Sep 28, 2016

Last Verified:

Sep 1, 2016

Keywords provided by Thomas E. Terndrup, Chair, Department of Emergency Medicine, Ohio State University

Study Results

No Results Posted as of Sep 28, 2016