Medical Emergencies Clinical Trial
— TECRISISOfficial 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
| 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 |
| Verified date | March 2022 |
| Source | Universidad de Antioquia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Colombia | Mario Andres Zamudio | Medellin | Antioquia |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad de Antioquia |
Colombia,
| 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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