Diagnostic ErrorsNCT01868659
Diagnostic Time-Out: A Randomized Clinical Trial of a Checklist to Improve Diagnostic Accuracy
A study testing Diagnostic checklist in people with Diagnostic Errors, run by University of Iowa.
Trial summary
Diagnostic errors are common, but they have been largely ignored by patient safety groups. Diagnostic errors are often traced to physicians' cognitive biases and failed heuristics (mental shortcuts). We know how these faulty thinking processes lead to diagnostic errors, but we know little about how to resist them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnostic Errors
- What is being tested?
- Diagnostic checklist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to May 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- English speaking
- Being seen for acute medical problem
- Patient in family medicine or emergency room
Who cannot join
- age under 18 years
About this study
Diagnostic errors are common, but they have been largely ignored by patient safety groups. Diagnostic errors are often traced to physicians' cognitive biases and failed heuristics (mental shortcuts). We know how these faulty thinking processes lead to diagnostic errors, but we know little about how to resist them. Faulty thinking has plagued other high-risk, high-reliability professionals, such as airline pilots and nuclear plant operators. These professions have learned from their mistakes and have developed checklists to help prevent them. The medical profession has started to use checklists and time-out periods in the operating room and intensive care unit, but these strategies have not been used to reduce diagnostic errors. The most common reason that physicians fail to make the correct diagnosis is that they never consider it. This failure could potentially be prevented if the physician took a time-out to review a checklist. Our broad long-term goal is to reduce diagnostic errors by developing interventions that help counter faulty diagnostic thinking. The specific aims of this project are to (1) determine the feasibility of taking a diagnostic time-out in the acute outpatient setting (urgent care clinic and emergency department), (2) determine if new diagnostic possibilities are seriously considered as a result of the time-out and checklist, and (3) compare the initial differential diagnosis with the new differential diagnosis following the time-out, and with the discharge diagnosis documented in the medical record, and with the "final" diagnosis based on a one-month follow-up. To achieve these aims, the investigators will ask 5 urgent-care physicians to complete a time-out procedure for 10 diagnostically challenging adult patients and 5 physicians will serve as controls (no time out) for 10 diagnostically challenging patients (total of 100 patients). The investigator will ask the intervention physicians to take a 2-minute time-out to review a complaint-specific differential-diagnosis checklist, which includes the differential diagnosis for 60 common presenting complaints, such as dyspnea and chest pain. The time-out will occur at the conclusion of the history and physical exam. We will use descriptive statistics and qualitative methods to characterize physicians' reactions to the time-out and checklists. We will use this pilot project to plan a larger study that will determine the risks and benefits of diagnostic time-outs and checklists.
Read the detailed description
Diagnostic errors are common. They are more common than medication errors and they are the second leading cause of malpractice claims. They are more likely to harm patients and more likely to be preventable than other kinds of errors. Yet they have been largely ignored by patient safety groups, which have focused more on system problems than thinking problems. Diagnostic errors are often traced to physicians' cognitive biases and failed heuristics (mental shortcuts). We know how these faulty thinking processes lead to diagnostic errors, but we know little about how to resist them. Faulty thinking has plagued other high-risk, high-reliability professionals, such as airline pilots and nuclear plant operators. These professions have learned from their mistakes and have developed checklists to help prevent them. The medical profession has started to use checklists and time-out periods in the operating room and intensive care unit, but these strategies have not been used to reduce diagnostic errors. The most common reason that physicians fail to make the correct diagnosis is that they never consider it. This failure could potentially be prevented if the physician took a time-out to review a checklist. Our broad long-term goal is to reduce diagnostic errors by developing interventions that help counter faulty diagnostic thinking. The specific aims of this project are to (1) determine the feasibility of taking a diagnostic time-out in the acute outpatient setting (urgent care clinic and emergency department), (2) determine if new diagnostic possibilities are seriously considered as a result of the time-out and checklist, and (3) compare the initial differential diagnosis with the new differential diagnosis following the time-out, and with the discharge diagnosis documented in the medical record, and with the "final" diagnosis based on a one-month follow-up. To achieve these aims, the investigators will ask 5 urgent-care physicians to complete a time-out procedure for 10 diagnostically challenging adult patients and 5 physicians will serve as controls (no time out) for 10 diagnostically challenging patients (total of 100 patients). The investigator will ask the intervention physicians to take a 2-minute time-out to review a complaint-specific differential-diagnosis checklist, which includes the differential diagnosis for 60 common presenting complaints, such as dyspnea and chest pain. The time-out will occur at the conclusion of the history and physical exam. We will use descriptive statistics and qualitative methods to characterize physicians' reactions to the time-out and checklists. We will use this pilot project to plan a larger study that will determine the risks and benefits of diagnostic time-outs and checklists.
- Conditions
- Diagnostic Errors
- Being tested
- Diagnostic checklist, Usual care with no diagnostic checklist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic checklistBehavioural
Diagnostic checklist used before patient discharged
Usual care with no diagnostic checklistBehavioural
Patient receives usual care with no research intervention
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic checklist | Experimental | Diagnostic checklist used before patient discharged Receives: Behavioral: Diagnostic checklist |
| Usual care | Placebo comparator | No diagnostic checklist used during patient encounter Receives: Behavioral: Usual care with no diagnostic checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Diagnoses will be considered "correct" if the one-month followup diagnosis exactly agrees with the final diagnosis recorded in the medical record at the time of the visit. The one-month followup diagnosis will be determined by the investigators after reviewing the medical record and a one-month telephone interview with the patient. Diagnoses will be labeled "trivial discrepancy" if the one-month followup diagnosis differs in a trivial manner with the final diagnosis recorded in the medical record at the time of the visit (e.g., viral upper respiratory infection vs. viral bronchitis). Diagnoses will be labeled "important discrepancy" if the one-month followup diagnosis differs in an important manner with the final diagnosis recorded in the medical record at the time of the visit (e.g., viral bronchitis vs. bacterial pneumonia).
Measured: 1 month after enrollment
Secondary outcomes (1)
Number of diagnoses in differential diagnosis
At the conclusion of the history and physical exam, physicians will be asked for their opinion about the primary diagnosis plus any other diagnoses they believe should be considered (i.e., the differential diagnosis). The number of diagnoses in the differential diagnosis will be compared for checklist physicians vs. no-checklist physicians.
Measured: 1 day (At time of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startApr 2010
- Primary completionNov 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ErrorsStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John W Ely, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868659
- Sponsor's protocol ID
- IRB201002794
- Status last verified
- May 2015
- First submitted
- 30 May 2013
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Time-Out: A Randomized Clinical Trial of a Checklist to Improve Diagnostic Accuracy
- ClinicalTrials.gov ID
- NCT01868659
- Acronym / sponsor ID
- IRB201002794
- Conditions
- Diagnostic Errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 4 Jun 2013 (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.
Diagnostic errors are common, but they have been largely ignored by patient safety groups. Diagnostic errors are often traced to physicians' cognitive biases and failed heuristics (mental shortcuts). We know how these faulty thinking processes lead to diagnostic errors, but we know little about how to resist them. Faulty thinking has plagued other high-risk, high-reliability professionals, such as airline pilots and nuclear plant operators. These professions have learned from their mistakes and have developed checklists to help prevent them. The medical profession has started to use checklists and time-out periods in the operating room and intensive care unit, but these strategies have not been used to reduce diagnostic errors. The most common reason that physicians fail to make the correct diagnosis is that they never consider it. This failure could potentially be prevented if the physician took a time-out to review a checklist. Our broad long-term goal is to reduce diagnostic errors by developing interventions that help counter faulty diagnostic thinking. The specific aims of this project are to (1) determine the feasibility of taking a diagnostic time-out in the acute outpatient setting (urgent care clinic and emergency department), (2) determine if new diagnostic possibilities are seriously considered as a result of the time-out and checklist, and (3) compare the initial differential diagnosis with the new differential diagnosis following the time-out, and with the discharge diagnosis documented in the medical record, and with the "final" diagnosis based on a one-month follow-up. To achieve these aims, the investigators will ask 5 urgent-care physicians to complete a time-out procedure for 10 diagnostically challenging adult patients and 5 physicians will serve as controls (no time out) for 10 diagnostically challenging patients (total of 100 patients). The investigator will ask the intervention physicians to take a 2-minute time-out to review a complaint-specific differential-diagnosis checklist, which includes the differential diagnosis for 60 common presenting complaints, such as dyspnea and chest pain. The time-out will occur at the conclusion of the history and physical exam. We will use descriptive statistics and qualitative methods to characterize physicians' reactions to the time-out and checklists. We will use this pilot project to plan a larger study that will determine the risks and benefits of diagnostic time-outs and checklists.
Detailed description
Diagnostic errors are common. They are more common than medication errors and they are the second leading cause of malpractice claims. They are more likely to harm patients and more likely to be preventable than other kinds of errors. Yet they have been largely ignored by patient safety groups, which have focused more on system problems than thinking problems. Diagnostic errors are often traced to physicians' cognitive biases and failed heuristics (mental shortcuts). We know how these faulty thinking processes lead to diagnostic errors, but we know little about how to resist them. Faulty thinking has plagued other high-risk, high-reliability professionals, such as airline pilots and nuclear plant operators. These professions have learned from their mistakes and have developed checklists to help prevent them. The medical profession has started to use checklists and time-out periods in the operating room and intensive care unit, but these strategies have not been used to reduce diagnostic errors. The most common reason that physicians fail to make the correct diagnosis is that they never consider it. This failure could potentially be prevented if the physician took a time-out to review a checklist. Our broad long-term goal is to reduce diagnostic errors by developing interventions that help counter faulty diagnostic thinking. The specific aims of this project are to (1) determine the feasibility of taking a diagnostic time-out in the acute outpatient setting (urgent care clinic and emergency department), (2) determine if new diagnostic possibilities are seriously considered as a result of the time-out and checklist, and (3) compare the initial differential diagnosis with the new differential diagnosis following the time-out, and with the discharge diagnosis documented in the medical record, and with the "final" diagnosis based on a one-month follow-up. To achieve these aims, the investigators will ask 5 urgent-care physicians to complete a time-out procedure for 10 diagnostically challenging adult patients and 5 physicians will serve as controls (no time out) for 10 diagnostically challenging patients (total of 100 patients). The investigator will ask the intervention physicians to take a 2-minute time-out to review a complaint-specific differential-diagnosis checklist, which includes the differential diagnosis for 60 common presenting complaints, such as dyspnea and chest pain. The time-out will occur at the conclusion of the history and physical exam. We will use descriptive statistics and qualitative methods to characterize physicians' reactions to the time-out and checklists. We will use this pilot project to plan a larger study that will determine the risks and benefits of diagnostic time-outs and checklists.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostic checklist | Experimental | Behavioral: Diagnostic checklistDiagnostic checklist used before patient discharged |
| Usual care | Placebo comparator | Behavioral: Usual care with no diagnostic checklistNo diagnostic checklist used during patient encounter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years
- English speaking
- Being seen for acute medical problem
- Patient in family medicine or emergency room
Key exclusion criteria (1 listed)
- age under 18 years
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 |
|---|---|---|
| Diagnostic checklistDiagnostic checklist used before patient discharged | Behavioural | Diagnostic checklist |
| Usual care with no diagnostic checklistPatient receives usual care with no research intervention | Behavioural | Usual care |
Primary outcome
Diagnostic accuracy
Time frame: 1 month after enrollment
Diagnoses will be considered "correct" if the one-month followup diagnosis exactly agrees with the final diagnosis recorded in the medical record at the time of the visit. The one-month followup diagnosis will be determined by the investigators after reviewing the medical record and a one-month telephone interview with the patient. Diagnoses will be labeled "trivial discrepancy" if the one-month followup diagnosis differs in a trivial manner with the final diagnosis recorded in the medical record at the time of the visit (e.g., viral upper respiratory infection vs. viral bronchitis). Diagnoses will be labeled "important discrepancy" if the one-month followup diagnosis differs in an important manner with the final diagnosis recorded in the medical record at the time of the visit (e.g., viral bronchitis vs. bacterial pneumonia).
1 secondary outcome
Number of diagnoses in differential diagnosis
Time frame: 1 day (At time of enrollment)
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 11 May 2016.
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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.
John W Ely, MD principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic checklist in people with Diagnostic Errors, run by University of Iowa.
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 4 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 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Diagnostic accuracy (time frame: 1 month after enrollment). 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 11 May 2016.