Pulmonary EmbolismNCT01752673
The Visualization of Uncertainty in Clinical Diagnostic Reasoning for Pulmonary Embolism
A study testing Visualized pulmonary embolism computer task model and Didactic review lecture in people with Pulmonary Embolism and Diagnostic Uncertainty, run by University of Calgary at 1 site in Canada.
Trial summary
Medical reasoning is a form of inquiry that examines the thought processes involved in making medical decisions. When physicians are faced with patients' symptoms or signs, their thought processes follow either direct shortcuts to suspect a diagnosis or go into a deeper and more analytic process to reach a diagnosis. Read more about this study
- Who is it for?
- Ages 24 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism, Diagnostic Uncertainty, Clinical Reasoning
- What is being tested?
- Visualized pulmonary embolism computer task model and Didactic review lecture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Oct 2011
- 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 24 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical students, University of Calgary, in clerkship who finished at least 4 weeks of a block of medicine rotation at any hospital site.
- First year subspecialty or Internal Medicine residents.
- Practicing physicians in the subspecialties of Internal Medicine or Emergency Medicine.
Who cannot join
- Physicians in the subspecialty of Haematology or Respiratory
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Visualization of Uncertainty in Clinical Diagnostic Reasoning for Pulmonary Embolism: a Randomized Controlled Trial.
Medical reasoning is a form of inquiry that examines the thought processes involved in making medical decisions. When physicians are faced with patients' symptoms or signs, their thought processes follow either direct shortcuts to suspect a diagnosis or go into a deeper and more analytic process to reach a diagnosis. The second pathway is less prone to biases and errors. This study explores whether the use of an interactive visual display of probabilities of pulmonary embolism generated from positive or negative test results will increase the adherence to evidence based guidelines in the diagnosis of pulmonary embolism.
- Conditions
- Pulmonary Embolism, Diagnostic Uncertainty, Clinical Reasoning, Evidence Based Medicine, Visualization of Uncertainty
- Being tested
- Visualized pulmonary embolism computer task model, Didactic review lecture
- Keywords
- randomized controlled study
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visualized pulmonary embolism computer task modelOther
This group of participants was presented and trained to use a visual representation of diagnostic pathway for pulmonary embolism. The design of this visual representation is based on Bayes theorem and cognition enhancing visual design principles.
Didactic review lectureOther
This group of participants was presented with a didactic lecture covering the diagnostic approach of pulmonary embolism.
| Study group | Role | What they receive |
|---|---|---|
| Visualized pulmonary embolism computer task model | Experimental | This group of participants was presented and trained to use a visual representation of diagnostic pathway for pulmonary embolism. The design of this visual representation is based on Bayes theorem and cognition enhancing visual design principles. Receives: Other: Visualized pulmonary embolism computer task model |
| Didactic review pulmonary embolism lecture | Active comparator | This group of participants was presented with a didactic lecture covering the diagnostic approach of pulmonary embolism. Receives: Other: Didactic review lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance with medical diagnostic reasoning pathway for pulmonary embolism.
Concordance with medical diagnostic reasoning pathway for a case presentation suggestive of pulmonary embolism will be reflected by whether participants are stopping prematurely or proceeding with diagnostic steps inappropriately.
Measured: Paper-based clinical case scenarios were completed within 2 hour after either intervention.
Secondary outcomes (1)
Time.
The overall time taken to solve each clinical scenario may give insight to which decision making process was predominant to solve each clinical scenario.
Measured: Paper-based clinical case scenarios were completed within 2 hour after either intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startMar 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghazwan Altabbaa, University of Calgary
- Investigators
- Ghazwan Altabbaa, MD MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752673
- Sponsor's protocol ID
- 23231
- Status last verified
- Dec 2012
- First submitted
- 12 Dec 2012
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Visualization of Uncertainty in Clinical Diagnostic Reasoning for Pulmonary Embolism: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01752673
- Acronym / sponsor ID
- 23231
- Conditions
- Pulmonary Embolism, Diagnostic Uncertainty, Clinical Reasoning, Evidence Based Medicine, Visualization of Uncertainty
- Keywords
- randomized controlled study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Dec 2012 (estimated)
- 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.
Medical reasoning is a form of inquiry that examines the thought processes involved in making medical decisions. When physicians are faced with patients' symptoms or signs, their thought processes follow either direct shortcuts to suspect a diagnosis or go into a deeper and more analytic process to reach a diagnosis. The second pathway is less prone to biases and errors. This study explores whether the use of an interactive visual display of probabilities of pulmonary embolism generated from positive or negative test results will increase the adherence to evidence based guidelines in the diagnosis of pulmonary embolism.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visualized pulmonary embolism computer task model | Experimental | Other: Visualized pulmonary embolism computer task modelThis group of participants was presented and trained to use a visual representation of diagnostic pathway for pulmonary embolism. The design of this visual representation is based on Bayes theorem and cognition enhancing visual design principles. |
| Didactic review pulmonary embolism lecture | Active comparator | Other: Didactic review lectureThis group of participants was presented with a didactic lecture covering the diagnostic approach of pulmonary embolism. |
Who may qualify
- Ages
- 24 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical students, University of Calgary, in clerkship who finished at least 4 weeks of a block of medicine rotation at any hospital site.
- First year subspecialty or Internal Medicine residents.
- Practicing physicians in the subspecialties of Internal Medicine or Emergency Medicine.
Key exclusion criteria (1 listed)
- Physicians in the subspecialty of Haematology or Respiratory
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 |
|---|---|---|
| Visualized pulmonary embolism computer task modelThis group of participants was presented and trained to use a visual representation of diagnostic pathway for pulmonary embolism. The design of this visual representation is based on Bayes theorem and cognition enhancing visual design principles. | Other | Visualized pulmonary embolism computer task model |
| Didactic review lectureThis group of participants was presented with a didactic lecture covering the diagnostic approach of pulmonary embolism. | Other | Didactic review pulmonary embolism lecture |
Primary outcome
Concordance with medical diagnostic reasoning pathway for pulmonary embolism.
Time frame: Paper-based clinical case scenarios were completed within 2 hour after either intervention.
Concordance with medical diagnostic reasoning pathway for a case presentation suggestive of pulmonary embolism will be reflected by whether participants are stopping prematurely or proceeding with diagnostic steps inappropriately.
1 secondary outcome
Time.
Time frame: Paper-based clinical case scenarios were completed within 2 hour after either intervention.
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 19 Dec 2012.
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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.
Ghazwan Altabbaa, MD MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visualized pulmonary embolism computer task model and Didactic review lecture in people with Pulmonary Embolism and Diagnostic Uncertainty, run by University of Calgary at 1 site in Canada.
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 3 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 19 Dec 2012. 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 Canada. 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?
Concordance with medical diagnostic reasoning pathway for pulmonary embolism. (time frame: Paper-based clinical case scenarios were completed within 2 hour after either intervention.). 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 19 Dec 2012.