ThinkingdiagnosisNCT04030975
Cognitive Process of Diagnostic Error in Emergency Physicians
An observational study of Thinking, run by Cathay General Hospital at 1 site in Taiwan.
Trial summary
Diagnostic error, Dual process model of reasoning) During the last decade, much emphasis has been placed on system solutions to patient safety problems. However, diagnostic error, despite being responsible for twice as many adverse events as medication error, has received little attention. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thinking
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2014to Nov 2015
- Phase
- Observational
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: emergency physicians
Who may be able to join
- trained emergency physicians
Who cannot join
- refused interview
Trial locations and contacts
1 site in 1 country.
About this study
Diagnostic error, Dual process model of reasoning) During the last decade, much emphasis has been placed on system solutions to patient safety problems. However, diagnostic error, despite being responsible for twice as many adverse events as medication error, has received little attention. The rate of diagnostic errors have been estimated to be between 0.6% to 12%.Some estimates are as high as 15%.The rate of negative outcome or adverse effects of diagnostic errors range from 6.9% to 17%. Most authors accept that the dual process model of reasoning explains how clinicians make diagnoses. The purpose of this study is to investigate why diagnostic errors occurred in the emergency departments (EDs).
Read the detailed description
Diagnostic error, Dual process model of reasoning) During the last decade, much emphasis has been placed on system solutions to patient safety problems. However, diagnostic error, despite being responsible for twice as many adverse events as medication error, has received little attention. The rate of diagnostic errors have been estimated to be between 0.6% to 12%.Some estimates are as high as 15%.The rate of negative outcome or adverse effects of diagnostic errors range from 6.9% to 17%. Most authors accept that the dual process model of reasoning explains how clinicians make diagnoses. The purpose of this study is to investigate why diagnostic errors occurred in the emergency departments (EDs). A qualitative study approach was used with in-depth semi-structured interviews conducted with emergency physicians to investigate the cognitive diagnosis process. The study takes place in the EDs of three hospitals in Taiwan. We chose the participants using a purposive sampling technique to yield a sample that would be most likely contribute significant information on the diagnostic process. Sampling continued until novel information was no longer being gathered. All audiotapes were transcribed verbatim. The transcripts are analyzed by two of the investigators based on the ground theory. Once all relevant codes were identified, they were grouped together into meaningful categories. These categories were then grouped under appropriate themes, which were used to generate a theory of diagnostic errors.
- Conditions
- Thinking
- Keywords
- diagnostic error
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| interview | emergency physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
generate a theory of diagnostic errors
Measured: Dec., 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study startMay 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThinkingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathay General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cardinal Tien Hospital
- Responsible party
- Principal investigator, Cathay General Hosp. IRB, Cathay General Hospital
- Investigators
- Chaou-Shune Lin, MD, Principal investigator, Hsinchu Cathay General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030975
- Sponsor's protocol ID
- CGH-P103018
- Other IDs
- CGH-P103018
- Acronym
- diagnosis
- Status last verified
- Jul 2019
- First submitted
- 27 May 2014
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Process of Diagnostic Error in Emergency Physicians
- ClinicalTrials.gov ID
- NCT04030975
- Acronym / sponsor ID
- diagnosis / CGH-P103018
- Conditions
- Thinking
- Keywords
- diagnostic error
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cathay General HospitalUniversity, hospital or other
- Collaborators
- Cardinal Tien Hospital
- Study start
- May 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Jul 2019 (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.
Diagnostic error, Dual process model of reasoning) During the last decade, much emphasis has been placed on system solutions to patient safety problems. However, diagnostic error, despite being responsible for twice as many adverse events as medication error, has received little attention. The rate of diagnostic errors have been estimated to be between 0.6% to 12%.Some estimates are as high as 15%.The rate of negative outcome or adverse effects of diagnostic errors range from 6.9% to 17%. Most authors accept that the dual process model of reasoning explains how clinicians make diagnoses. The purpose of this study is to investigate why diagnostic errors occurred in the emergency departments (EDs).
Detailed description
Diagnostic error, Dual process model of reasoning) During the last decade, much emphasis has been placed on system solutions to patient safety problems. However, diagnostic error, despite being responsible for twice as many adverse events as medication error, has received little attention. The rate of diagnostic errors have been estimated to be between 0.6% to 12%.Some estimates are as high as 15%.The rate of negative outcome or adverse effects of diagnostic errors range from 6.9% to 17%. Most authors accept that the dual process model of reasoning explains how clinicians make diagnoses. The purpose of this study is to investigate why diagnostic errors occurred in the emergency departments (EDs). A qualitative study approach was used with in-depth semi-structured interviews conducted with emergency physicians to investigate the cognitive diagnosis process. The study takes place in the EDs of three hospitals in Taiwan. We chose the participants using a purposive sampling technique to yield a sample that would be most likely contribute significant information on the diagnostic process. Sampling continued until novel information was no longer being gathered. All audiotapes were transcribed verbatim. The transcripts are analyzed by two of the investigators based on the ground theory. Once all relevant codes were identified, they were grouped together into meaningful categories. These categories were then grouped under appropriate themes, which were used to generate a theory of diagnostic errors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interview | – | –emergency physicians |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- emergency physicians
Key inclusion criteria (1 listed)
- trained emergency physicians
Key exclusion criteria (1 listed)
- refused interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
generate a theory of diagnostic errors
Time frame: Dec., 2015
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 24 Jul 2019.
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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.
Chaou-Shune Lin, MD principal investigator
Hsinchu Cathay General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thinking, run by Cathay General Hospital at 1 site in Taiwan.
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 24 Jul 2019. 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 Taiwan. 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?
generate a theory of diagnostic errors (time frame: Dec., 2015). 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 24 Jul 2019; AzTrials last refreshed its copy on 29 Oct 2026.