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Diagnostic Time-Out: A Randomized Clinical Trial of a Checklist to Improve Diagnostic Accuracy

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ClinicalTrials.gov Identifier: NCT01868659
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
University of Iowa

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Diagnostic Errors Behavioral: Diagnostic checklist Behavioral: Usual care with no diagnostic checklist Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Time-Out: A Randomized Clinical Trial of a Checklist to Improve Diagnostic Accuracy
Study Start Date : April 2010
Actual Primary Completion Date : November 2014
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: Diagnostic checklist
Diagnostic checklist used before patient discharged
Behavioral: Diagnostic checklist
Diagnostic checklist used before patient discharged

Placebo Comparator: Usual care
No diagnostic checklist used during patient encounter
Behavioral: Usual care with no diagnostic checklist
Patient receives usual care with no research intervention




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Number of diagnoses in differential diagnosis [ Time Frame: 1 day (At time of enrollment) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18 years
  • English speaking
  • Being seen for acute medical problem
  • Patient in family medicine or emergency room

Exclusion Criteria:

  • age under 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868659


Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: John W Ely, MD University of Iowa

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01868659     History of Changes
Other Study ID Numbers: IRB201002794
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2015