Quality of Medical History Taking and Diagnostic Accuracy

NCT05760859 | Completed

• 1 other identifier: 4031_Sim_MedHistory
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized simulator-based single-blind trial aimed to investigate the effects of initial cues and history taking skills on diagnostic accuracy

Conditions

Diagnostic Error

Keywords

medical simulation; diagnostic error; pulmonary embolism

Outcome Measures

Primary Outcomes (1)

• Stating the correct diagnosis

  At the end of the study time (5 minutes), a study physician enters the simulator room and asks the participate on his/her presumptive diagnosis. Simualtions are video-taped and the analysis of the outcome is performed by trained observers by video analysis. "Stating the correct diagnosis" is a binary outcome, rated either as "yes" (correct presumptive diagnosis of pulmonary embolism is stated) or "no" (correct presumptive diagnosis of pulmonary embolism is NOT stated).

  5 minutes

Secondary Outcomes (3)

• Depth of history taking

  5 minutes

• Breadth of history taking

  5 minutes

• Systematics of history taking

  5 minutes

Study Arms (6)

Chest pain

EXPERIMENTAL

Patient answers the initial question of history taking on why he had come to the hospital with "Chest pain"

Other: Initial cue

Dyspnoea

EXPERIMENTAL

Patient answers the initial question of history taking on why he had come to the hospital with "Dyspnoea"

Other: Initial cue

Chest pain AND Dyspnoea

EXPERIMENTAL

Patient answers the initial question of history taking on why he had come to the hospital with "Chest pain, and Dyspnoea"

Other: Initial cue

Chest pain AND dyspnoea, AND leg pain

EXPERIMENTAL

Patient answers the initial question of history taking on why he had come to the hospital with "Chest pain, and Dyspnoea, and leg pain"

Other: Initial cue

Chest pain AND dyspnoea, AND immobilization

EXPERIMENTAL

Patient answers the initial question of history taking on why he had come to the hospital with "Chest pain, and Dyspnoea, and immobilization"

Other: Initial cue

Chest pain AND dyspnoea, AND leg pain AND immobilization

EXPERIMENTAL

Patient answers the initial question of history taking on why he had come to the hospital with "Chest pain, and Dyspnoea, and leg pain, and immobilization"

Other: Initial cue

Interventions

Initial cue OTHER

Symptom volunteered by the "patient"

Chest pain; Chest pain AND Dyspnoea; Chest pain AND dyspnoea, AND immobilization; Chest pain AND dyspnoea, AND leg pain; Chest pain AND dyspnoea, AND leg pain AND immobilization; Dyspnoea

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• th year medical students participating in voluntary simulator-based workshops

You may not qualify if:

• decline to give written informed consent

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stephan Marsch, MD

  University Hospital of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind trial; participants not aware of the goal of the study
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized (computer-generated numbers) to six versions of a simulated scenario of pulmonary embolism. The six versions differed only in the initial cues, i.e. in the reply of the patient to the initial question about the reason for his visit.

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 8, 2023
• Study Start: March 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)