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

NCT01868659 | Completed

• 1 other identifier: IRB201002794
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diagnostic Errors

Outcome Measures

Primary Outcomes (1)

• 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).

  1 month after enrollment

Secondary Outcomes (1)

• Number of diagnoses in differential diagnosis

  1 day (At time of enrollment)

Study Arms (2)

Diagnostic checklist

EXPERIMENTAL

Diagnostic checklist used before patient discharged

Behavioral: Diagnostic checklist

Usual care

PLACEBO COMPARATOR

No diagnostic checklist used during patient encounter

Behavioral: Usual care with no diagnostic checklist

Interventions

Diagnostic checklist BEHAVIORAL

Diagnostic checklist used before patient discharged

Diagnostic checklist

Usual care with no diagnostic checklist BEHAVIORAL

Patient receives usual care with no research intervention

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• age under 18 years

Sponsors & Collaborators

• University of Iowa: lead

Study Officials

• John W Ely, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 4, 2013
• Study Start: April 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 11, 2016

Record last verified: 2015-05