Diagnostic ErrorNCT05760859
Quality of Medical History Taking and Diagnostic Accuracy
A study testing Initial cue in people with Diagnostic Error, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Error
- What is being tested?
- Initial cue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 4th year medical students participating in voluntary simulator-based workshops
Who cannot join
- decline to give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Initial Cues and the Quality of Medical History Taking on 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
Read the 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.
- Conditions
- Diagnostic Error
- Being tested
- Initial cue
- Keywords
- medical simulation, diagnostic error, pulmonary embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial cueOther
Symptom volunteered by the "patient"
| Study group | Role | What they receive |
|---|---|---|
| Chest pain | Experimental | Patient answers the initial question of history taking on why he had come to the hospital with "Chest pain" Receives: Other: Initial cue |
| Dyspnoea | Experimental | Patient answers the initial question of history taking on why he had come to the hospital with "Dyspnoea" Receives: 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" Receives: 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" Receives: 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" Receives: 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" Receives: Other: Initial cue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 minutes
Secondary outcomes (3)
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.
Measured: 5 minutes
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).
Measured: 5 minutes
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%)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study startMar 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ErrorStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Marsch, MD, Principal investigator, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760859
- Sponsor's protocol ID
- 4031_Sim_MedHistory
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Video recordings are confidential and cannot be shared. Extracted data can be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Initial Cues and the Quality of Medical History Taking on Diagnostic Accuracy
- ClinicalTrials.gov ID
- NCT05760859
- Acronym / sponsor ID
- 4031_Sim_MedHistory
- Conditions
- Diagnostic Error
- Keywords
- medical simulation, diagnostic error, pulmonary embolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized simulator-based single-blind trial aimed to investigate the effects of initial cues and history taking skills on diagnostic accuracy
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chest pain | Experimental | Other: Initial cuePatient answers the initial question of history taking on why he had come to the hospital with "Chest pain" |
| Dyspnoea | Experimental | Other: Initial cuePatient answers the initial question of history taking on why he had come to the hospital with "Dyspnoea" |
| Chest pain AND Dyspnoea | Experimental | Other: Initial cuePatient answers the initial question of history taking on why he had come to the hospital with "Chest pain, and Dyspnoea" |
| Chest pain AND dyspnoea, AND leg pain | Experimental | Other: Initial cuePatient answers the initial question of history taking on why he had come to the hospital with "Chest pain, and Dyspnoea, and leg pain" |
| Chest pain AND dyspnoea, AND immobilization | Experimental | Other: Initial cuePatient answers the initial question of history taking on why he had come to the hospital with "Chest pain, and Dyspnoea, and immobilization" |
| Chest pain AND dyspnoea, AND leg pain AND immobilization | Experimental | Other: Initial cuePatient 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" |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 4th year medical students participating in voluntary simulator-based workshops
Key exclusion criteria (1 listed)
- decline to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial cueSymptom volunteered by the "patient" | Other | 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 |
Primary outcome
Stating the correct diagnosis
Time frame: 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).
3 secondary outcomes
Depth of history taking
Time frame: 5 minutes
Breadth of history taking
Time frame: 5 minutes
Systematics of history taking
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No. Video recordings are confidential and cannot be shared. Extracted data can be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Marsch, MD principal investigator
University Hospital of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial cue in people with Diagnostic Error, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stating the correct diagnosis (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.