Non-technical Skills Training and Checklists Versus Standard Training With Checklists for Prevention of Medical Error (TECRISIS)

Non-technical Skills Training and Checklists Versus Standard Training With Checklists in Boarding School Students to Reduce Simulation Crisis Medical Error, Randomized Controlled Clinical Trial

The purpose of this study is to reduce medical error by omitting management steps in medical crises. The Interventions will be: training in non-technical skills and checklists versus Control: standard training with checklists

Study Overview

• Status: Completed
• Conditions: Medical Emergencies
• Intervention / Treatment: Other: Non technical skills and checklist training in simulation; Other: Checklist training simulation

Detailed Description

56 participants will be searched for simulation training, randomly assigned in assignment 1 to 1, the follow-up will be 10 days, the primary outcome will be Proportion of omissions of treatment steps per group, and secondary outcomes will be sought. Crisis resolution time, detection time. and discrimination from the crisis Global score of non-technical skills, Discriminated score between dimensions of non-technical skills, Student satisfaction and Incidence of inadequate crisis management.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Mario Andres Zamudio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• over 18 years old.
• Final semester student of medicine at the University of Antioquia.
• Have passed the theoretical knowledge exam for handling crisis events with a score of 100%.
• On-site availability on training days

Exclusion Criteria:

• Having received training in a specific crisis resource management course.
• Refusing to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non technical skills and check list; 10 hours of training in non-technical skills and checklists in high Fidelity simulation	Other: Non technical skills and checklist training in simulation; using structured debrifing, in three random medical simulation crises, training in non-technical skills will be carried out
Active Comparator: check list; Control: 10 hours of standard training with checklists in high Fidelity simulation	Other: Checklist training simulation; using structured debrifing, in three random medical simulation crises, training in checklist will be carried out

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical error	Proportion of omission of treatment steps over the total number of steps per group.	3 days after finishing the training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall score on non-technical skills scale Ottawa	Mean interval difference per group between 1 to 45 Brief Name: Ottawa Global Rating Scale (GRS) Minimum value: 1 Maximum value: 45 Higher scores mean a better outcome	3 days after finishing the training
score for each non-technical skill category on the ottawa scale	Mean interval difference per group between 1 to 7 Brief Name: Ottawa Global Rating Scale (GRS)/ For Category Minimum value: 1 Maximum value: 7 Higher scores mean a better outcome	3 days after finishing the training
Crisis resolution time	Mean interval difference per group	3 days after finishing the training
Time in detection and discrimination of the crisis	Mean interval difference per group	3 days after finishing the training
Incidence of improper handling	relative risk	3 days after finishing the training
Student understanding of strategies	qualitative analysis with grounded theory after conducting semi-structured interviews	10 days after finishig the primary outcome

Collaborators and Investigators

• Sponsor: Universidad de Antioquia

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2021
• Primary Completion (Actual): July 18, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 5, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: checklist; medical error; high fidelity simulation; non technical skills
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: F070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: through email communication with the lead author
• IPD Sharing Time Frame: 10 years
• IPD Sharing Access Criteria: through email communication with the lead author
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No