Back to resultsNon-technical Skills Training and Checklists Versus Standard Training With Checklists for Prevention of Medical Error (TECRISIS)
Primary Purpose
Medical Emergencies
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Non technical skills and checklist training in simulation
Checklist training simulation
Sponsored by
About this trial
This is an interventional other trial for Medical Emergencies focused on measuring medical error, high fidelity simulation, non technical skills, checklist
Eligibility Criteria
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
Sites / Locations
- Mario Andres Zamudio
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Non technical skills and check list
check list
Arm Description
10 hours of training in non-technical skills and checklists in high Fidelity simulation
Control: 10 hours of standard training with checklists in high Fidelity simulation
Outcomes
Primary Outcome Measures
Medical error
Proportion of omission of treatment steps over the total number of steps per group.
Secondary Outcome Measures
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
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
Crisis resolution time
Mean interval difference per group
Time in detection and discrimination of the crisis
Mean interval difference per group
Incidence of improper handling
relative risk
Student understanding of strategies
qualitative analysis with grounded theory after conducting semi-structured interviews
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04621682
Brief Title
Non-technical Skills Training and Checklists Versus Standard Training With Checklists for Prevention of Medical Error
Acronym
TECRISIS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2021 (Actual)
Primary Completion Date
July 18, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Antioquia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medical Emergencies
Keywords
medical error, high fidelity simulation, non technical skills, checklist
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
TECRISIS is a study designed as a controlled clinical trial of superiority with parallel groups, random allocation and blinding of investigators who measure outcome.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non technical skills and check list
Arm Type
Active Comparator
Arm Description
10 hours of training in non-technical skills and checklists in high Fidelity simulation
Arm Title
check list
Arm Type
Active Comparator
Arm Description
Control: 10 hours of standard training with checklists in high Fidelity simulation
Intervention Type
Other
Intervention Name(s)
Non technical skills and checklist training in simulation
Intervention Description
using structured debrifing, in three random medical simulation crises, training in non-technical skills will be carried out
Intervention Type
Other
Intervention Name(s)
Checklist training simulation
Intervention Description
using structured debrifing, in three random medical simulation crises, training in checklist will be carried out
Primary Outcome Measure Information:
Title
Medical error
Description
Proportion of omission of treatment steps over the total number of steps per group.
Time Frame
3 days after finishing the training
Secondary Outcome Measure Information:
Title
Overall score on non-technical skills scale Ottawa
Description
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
Time Frame
3 days after finishing the training
Title
score for each non-technical skill category on the ottawa scale
Description
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
Time Frame
3 days after finishing the training
Title
Crisis resolution time
Description
Mean interval difference per group
Time Frame
3 days after finishing the training
Title
Time in detection and discrimination of the crisis
Description
Mean interval difference per group
Time Frame
3 days after finishing the training
Title
Incidence of improper handling
Description
relative risk
Time Frame
3 days after finishing the training
Title
Student understanding of strategies
Description
qualitative analysis with grounded theory after conducting semi-structured interviews
Time Frame
10 days after finishig the primary outcome
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mario Andres Zamudio
City
Medellin
State/Province
Antioquia
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Non-technical Skills Training and Checklists Versus Standard Training With Checklists for Prevention of Medical Error
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