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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05760859
Other study ID # 4031_Sim_MedHistory
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date December 2019

Study information

Verified date March 2023
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Diagnostic errors are a relevant health-care problem. As medical history taking is usually the first step in a patient's assessment its quality is most likely a first and important barrier against diagnostic errors. There are, however, only limited data on the association of the quality of medical history taking and diagnostic accuracy.This prospective randomized simulator-based single-blind trial aimed to investigate the effects of initial cues and history taking skills on diagnostic accuracy. 198 medical students (135 females) were given the task to assess a patient presenting with simulated acute pulmonary embolism. Participants were randomized to six versions of the scenario differing only in the initial cues, i.e. in the reply of the patient to the initial question about the reason for his visit. In three of six versions, initial cues were restricted to thoracic symptoms (chest pain, dyspnoea, or combination of both). In the remaining three versions, initial cues consisted of thoracic and extra-thoracic (leg pain, immobilization) symptoms. The primary outcome was diagnostic accuracy. The mannequin was equipped with a speaker in its head that broadcasts the voice of a remote operator (experienced physician) allowing verbal interaction of the participants with the "patient". The "patient" did not speak unless asked and responded to all participants' questions during history taking according to a pre-defined checklist.


Recruitment information / eligibility

Status Completed
Enrollment 198
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - 4th year medical students participating in voluntary simulator-based workshops Exclusion Criteria: - decline to give written informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Initial cue
Symptom volunteered by the "patient"

Locations

Country Name City State
Switzerland University Hospital Basel BS

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Depth of history taking Data analysis is performed using video-recordings recorded during scenarios. Trained observers note kind and timing of all questions. Questions were categorized in six pre-defined categories (chest pain, dyspnoea,associated symptoms, risk factors for pulmonary embolism,cardiovascular risk factors, personal history). Depth of information gathering is assessed for each category separately and is defined as the total number of questions asked in any given category. 5 minutes
Secondary Breadth of history taking Data analysis is performed using video-recordings recorded during scenarios. Trained observers note kind and timing of all questions. The three problem areas chest pain, dyspnea, and leg pain or leg swelling were defined à priori as relevant. Breadth of information gathering is defined as number of relevant problem areas identified (possible range from 0 to 3). 5 minutes
Secondary Systematics of history taking Data analysis is performed using video-recordings recorded during scenarios. Trained observers note kind and timing of all questions. Questions were categorized in six pre-defined categories (chest pain, dyspnoea,associated symptoms, risk factors for pulmonary embolism,cardiovascular risk factors, personal history). All questions will be rated as either "systematic question" or "non-systematic question". A systematic questions is defined as question, that is either immediately preceded or immediately followed by a question of the same category. "Systematic questions" will be expressed as percentage of all questions asked during history taking (possible range 0% to 100%) 5 minutes
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