Quality of Medical History Taking and Diagnostic Accuracy

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT05760859
Collaborator
(none)
198
1
6
69
2.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Initial cue
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
198 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Single (Participant)
Masking Description:
Single-blind trial; participants not aware of the goal of the study
Primary Purpose:
Diagnostic
Official Title:
Effects of Initial Cues and the Quality of Medical History Taking on Diagnostic Accuracy
Actual Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chest pain

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

Other: Initial cue
Symptom volunteered by the "patient"

Experimental: Dyspnoea

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

Other: Initial cue
Symptom volunteered by the "patient"

Experimental: Chest pain AND Dyspnoea

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

Other: Initial cue
Symptom volunteered by the "patient"

Experimental: Chest pain AND dyspnoea, AND leg pain

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
Symptom volunteered by the "patient"

Experimental: Chest pain AND dyspnoea, AND immobilization

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
Symptom volunteered by the "patient"

Experimental: Chest pain AND dyspnoea, AND leg pain AND immobilization

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
Symptom volunteered by the "patient"

Outcome Measures

Primary Outcome Measures

  1. Stating the correct diagnosis [5 minutes]

    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).

Secondary Outcome Measures

  1. Depth of history taking [5 minutes]

    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.

  2. Breadth of history taking [5 minutes]

    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).

  3. Systematics of history taking [5 minutes]

    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%)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 4th year medical students participating in voluntary simulator-based workshops
Exclusion Criteria:
  • decline to give written informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Basel BS Switzerland 4031

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Stephan Marsch, MD, University Hospital of Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT05760859
Other Study ID Numbers:
  • 4031_Sim_MedHistory
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Basel, Switzerland

Study Results

No Results Posted as of Mar 8, 2023