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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04621682
Other study ID # F070
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2021
Est. completion date August 1, 2021

Study information

Verified date March 2022
Source Universidad de Antioquia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date August 1, 2021
Est. primary completion date July 18, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
Checklist training simulation
using structured debrifing, in three random medical simulation crises, training in checklist will be carried out

Locations

Country Name City State
Colombia Mario Andres Zamudio Medellin Antioquia

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Medical error Proportion of omission of treatment steps over the total number of steps per group. 3 days after finishing the training
Secondary 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
Secondary 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
Secondary Crisis resolution time Mean interval difference per group 3 days after finishing the training
Secondary Time in detection and discrimination of the crisis Mean interval difference per group 3 days after finishing the training
Secondary Incidence of improper handling relative risk 3 days after finishing the training
Secondary Student understanding of strategies qualitative analysis with grounded theory after conducting semi-structured interviews 10 days after finishig the primary outcome
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