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

NCT04621682 | Completed

• 1 other identifier: F070
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Medical Emergencies

Keywords

medical error; high fidelity simulation; non technical skills; checklist

Outcome Measures

Primary Outcomes (1)

• Medical error

  Proportion of omission of treatment steps over the total number of steps per group.

  3 days after finishing the training

Secondary Outcomes (6)

• Overall score on non-technical skills scale Ottawa

  3 days after finishing the training

• score for each non-technical skill category on the ottawa scale

  3 days after finishing the training

• Crisis resolution time

  3 days after finishing the training

• Time in detection and discrimination of the crisis

  3 days after finishing the training

• Incidence of improper handling

  3 days after finishing the training

Study Arms (2)

Non technical skills and check list

ACTIVE COMPARATOR

10 hours of training in non-technical skills and checklists in high Fidelity simulation

Other: Non technical skills and checklist training in simulation

check list

ACTIVE COMPARATOR

Control: 10 hours of standard training with checklists in high Fidelity simulation

Other: Checklist training simulation

Interventions

Non technical skills and checklist training in simulation OTHER

using structured debrifing, in three random medical simulation crises, training in non-technical skills will be carried out

Non technical skills and check list

Checklist training simulation OTHER

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

check list

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

Mario Andres Zamudio

Medellín, Antioquia, Colombia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: TECRISIS is a study designed as a controlled clinical trial of superiority with parallel groups, random allocation and blinding of investigators who measure outcome.

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: November 9, 2020
• Study Start: March 20, 2021
• Primary Completion: July 18, 2021
• Study Completion: August 1, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 10 years
• Access Criteria: through email communication with the lead author

Locations

CO (1)