A Priori Diagnosis and Diagnostic Errors

NCT04659265 | Completed

• 1 other identifier: 4031-Sim-1
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized single-blind simulator-based trial. 156 4th year medical students were randomised to receive one of three different suspected diagnoses of a pre-treating physician (no diagnosis, myocardial infarction, pulmonary embolism) prior to the task to make a focussed assessment and perform first management steps in a patient presenting to the emergency department. The patient (simulator) suffered from an acute myocardial infarction. Video recordings were obtained during simulation and used for data analysis. Primary endpoint was the participants' final presuptive diagnosis.

Conditions

Error Disclosure; Diagnoses Disease; Simulation of Physical Illness

Keywords

diagnostic error; presumptive diagnosis

Outcome Measures

Primary Outcomes (1)

• Correct diagnosis

  Correct presumptive diagnosis

  5 minutes

Secondary Outcomes (2)

• number and kind of questions asked during history taking

  5 minutes

• probing of the à priori diagnosis

  5 minutes

Study Arms (3)

No suspected diagnosis (control group)

ACTIVE COMPARATOR

Participants receive the information that the pre-treating physician thought that the patient is suffering from a medical emergency (no diagnosis).

Other: Suspected diagnosis of a pre-treating physician

Correct suspected diagnosis

ACTIVE COMPARATOR

Participants receive the information that the pre-treating physician thought that the patient is suffering from an acute myocardial infarction (correct diagnosis).

Other: Suspected diagnosis of a pre-treating physician

Wrong suspected diagnosis

ACTIVE COMPARATOR

Participants receive the information that the pre-treating physician thought that the patient is suffering from a pulmonary embolism (wrong diagnosis).

Other: Suspected diagnosis of a pre-treating physician

Interventions

Suspected diagnosis of a pre-treating physician OTHER

Participants receive the information that the pre-treating physician thought the patient is suffering from a medical emergency (no diagnosis), an acute myocardial infarction (correct diagnosis) or a pulmonary embolism (wrong diagnosis)

Correct suspected diagnosis; No suspected diagnosis (control group); Wrong suspected diagnosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• th year medical students and physicians taking part in simulation workshops

You may not qualify if:

• no consent given to video-tape simulation and analyse vide recordings for scientific purpose

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Medical Intensive Care; University of Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Study Officials

• Stephan Marsch

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants not aware of the study goal
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Intensive Care

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 9, 2020
• Study Start: January 1, 2011
• Primary Completion: June 1, 2019
• Study Completion: February 1, 2020
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)