Improving Patient Safety Through Simulation Research (REDSTAMP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Thomas E. Terndrup, Ohio State University
ClinicalTrials.gov Identifier:
NCT02097498
First received: February 18, 2014
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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 Intervention
Educational Tool Assessment
Other: Simulation with feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Remote Expert Direction and Simulation Training in Airway Management With Paramedics

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Validity of assessment tool [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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:
  • Skill retention [ Time Frame: One and two years after enrollment ] [ Designated as safety issue: No ]
    The paramedics will be reassessed at 12 and 24 months to determine whether skill level was maintained and human cases will be assessed for actual airway management success.


Estimated Enrollment: 250
Study Start Date: August 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Simulation only
One group will be randomized to receive simulation training similar to that required for certification
Experimental: Simulation with feedback
Participants will be filmed during the simulation, then given specific feedback on how to improve.
Other: Simulation with feedback
Group will receive feedback from an airway management expert linked to the simulation test site via a 2-way audio-video feed

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Currently certified central Ohio paramedics

Exclusion Criteria:

  • Refusal to participate
  • Non-certified paramedics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097498

Contacts
Contact: Thomas E Terndrup, MD 6142938176 thomas.terndrup@osumc.edu

Locations
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Melanie R Heinlein, BS, CCRP    614-366-6852    melanie.heinlein@osumc.edu   
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Thomas E Terndrup, MD The Ohio State University Wexner Medical Center
  More Information

No publications provided

Responsible Party: Thomas E. Terndrup, Chair, Department of Emergency Medicine, Ohio State University
ClinicalTrials.gov Identifier: NCT02097498     History of Changes
Other Study ID Numbers: 2013H0226
Study First Received: February 18, 2014
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Simulation
Enhance
safety
proficiency
paramedics.

ClinicalTrials.gov processed this record on October 22, 2014