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

NCT ID: NCT01868659

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2015-05-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic checklist

Diagnostic checklist used before patient discharged

Group Type: EXPERIMENTAL

Diagnostic checklist

Intervention Type: BEHAVIORAL

Diagnostic checklist used before patient discharged

Usual care

No diagnostic checklist used during patient encounter

Group Type: PLACEBO_COMPARATOR

Usual care with no diagnostic checklist

Intervention Type: BEHAVIORAL

Patient receives usual care with no research intervention

Interventions

Diagnostic checklist

Diagnostic checklist used before patient discharged

Intervention Type: BEHAVIORAL

Usual care with no diagnostic checklist

Patient receives usual care with no research intervention

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John W Ely, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Other Identifiers

IRB201002794

Identifier Type: -

Identifier Source: org_study_id