Facilitating Adaptive Expertise in Learning Computed Tomography (FAIL CT)

March 31, 2024 updated by: Leonardo Aliaga, Stanford University

The FAIL CT Study: Facilitating Adaptive Expertise in Learning Computed Tomography, a Multi-center Randomized Controlled Trial

The main objective of this study is to demonstrate that Error Management Training improves adaptive expertise in head computed tomography interpretation. The investigators will conduct a randomized controlled trial comparing two learning strategies, Error Management Training vs Error Avoidance Training, in emergency medicine residents. The investigators hypothesize that Error Management Training, as compared to Error Avoidance Training, will improve adaptive expertise, as measured by skills transfer, when used to teach head computed tomography interpretation to emergency medicine residents.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Adaptive expertise is the ability to apply existing skills to novel situations. Adaptive expertise enables physicians to reduce preventable medical errors when managing clinical scenarios not encountered during training. However, residency curricula rarely address this learning outcome. Error Management Training improves transfer of skills to new contexts and develops adaptive expertise. Although this methodology has been shown to improve adaptive expertise in procedural skills, its impact on cognitive skills in medical training remains underexplored. Error Management Training promises to improve patient care by developing emergency physicians' adaptive expertise. However, the investigators need further evidence for its efficacy with cognitive skills in residency training. The investigators aim to demonstrate that Error Management Training improves adaptive expertise in a cognitive skill, using head computed tomography interpretation as a model.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Study participation will be available to all current emergency medicine residents at Stanford and at thirteen external sites.

Exclusion Criteria:

  • Adults unable to consent
  • Pregnant women
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners
  • Medical students
  • Residents from specialties other than emergency medicine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Error Management Training (Difficult)
Participants receive the learning strategy Error Management Training and encounter difficult questions.
Other: Error Management Training (Difficult)
Error Management Training is used to teach head computed tomography interpretation. Participants encounter difficult questions.
Experimental: Error Management Training (Easy)
Participants receive the learning strategy Error Management Training and encounter easy questions.
Other: Error Management Training (Easy)
Error Management Training is used to teach head computed tomography interpretation. Participants encounter easy questions.
Active Comparator: Error Avoidance Training
Participants receive the learning strategy Error Avoidance Training.
Other: Error Avoidance Training
Error Avoidance Training used to teach head computed tomography interpretation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent correct on an assessment of transfer of skills (adaptive expertise)
Time Frame: Immediately after instructional session (up to 60 minutes to complete the assessment)
Participants will have to demonstrate transfer of head computed tomography interpretation skills by interpreting novel radiology cases different from those used in the instructional session. Performance will be assessed by percent score on a head computed tomography interpretation test using novel radiology content not addressed in the instructional session. Score range is 0-100%.
Immediately after instructional session (up to 60 minutes to complete the assessment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent correct on an assessment of post-session proficiency for learning objectives (routine expertise)
Time Frame: Immediately after instructional session (up to 60 minutes to complete the assessment)
Participants will have to demonstrate direct application of the intervention's learning objectives by interpreting radiology cases similar to those used in the instructional session. Performance will be assessed by percent score on a head computed tomography interpretation test using radiology content similar to that used in the instructional session. Score range is 0-100%.
Immediately after instructional session (up to 60 minutes to complete the assessment)
Effect of post-graduate year level on post-test performance
Time Frame: Immediately after instructional session (up to 60 minutes to complete the assessment)
Performance on a head computed tomography interpretation test (both adaptive expertise and routine expertise cases) will be assessed by percent score, stratified by post-graduate year level to show differences across residency training stage. Score range is 0-100%.
Immediately after instructional session (up to 60 minutes to complete the assessment)
Mediation effect of errors on performance on the adaptive expertise cases
Time Frame: Number of errors will be measured during the educational intervention
The number of errors made during the educational intervention will be measured for both the Error Management Training (Difficult) arm and the Error Management Training (Easy) arm. A mediation analysis will be conducted to assess the effect of committing errors during learning on subsequent performance in the cases measuring adaptive expertise.
Number of errors will be measured during the educational intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Texas Health Science Center, Houston
University of California, Los Angeles
University of Chicago
Brown University
University of Wisconsin, Madison
Vanderbilt University
Alameda Health System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leonardo Aliaga, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 64099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plan to share data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings