Perceptual Expertise Training for Triage of Moles

September 21, 2018 updated by: June Robinson, Northwestern University

Perceptual Training to Improve Early Detection of Melanoma by Future Healthcare Providers: to Accuarate Triage of Benign vs. Malignant Pigmented Skin Lesions

The aim of this study is to assess a novel educational mobile and online application which will use images of pigmented skin lesions with question prompts to train future medical providers to more accurately detect malignant lesions.

The hypothesis of this study is that this new educational tool will result in higher melanoma detection rates among future providers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Objective: To design an online and mobile course in which participants will learn to triage pigmented lesions as benign or malignant. The course will use images and question prompts to train users in pattern recognition with the goal of increased diagnostic accuracy.

Secondary Objective: To assess the effectiveness of this course. Students will be asked to rank their confidence when answering questions at the end of each module and confidence over time will be tracked. Students will also be asked to complete a post-course survey which will include an externally validated, 10 question usability scale. Responses will be standardized and compared across participants.

The study will take place at Northwestern University Feinberg School of Medicine over a 2 year time course. Initially, participants will assess the diameter of pigmented lesions with and without a ruler incorporated in the image of a pigmented lesion that contains at least one hair (Phase 1). Next, participants will be asked to complete an online/mobile course with the goal of learning to triage pigmented lesions as benign or malignant. (Phase 2) (Figure 1) These will be accessed on personal smart phones and/or computers. The course will consist of four modules of increasing difficulty. These modules will be completed in (4) 20 minute sessions over the course of 2 weeks. Each module will pair 4 images of benign lesion with 4 images of melanomas. Each sequential module will incorporate one new type of benign lesion as well as re-introduced images that were triaged incorrectly in previous modules.

At the end of each module, participants will be asked to rate their confidence in answering triaging lesions on a scale of 1-10. The change in confidence rating between Module 1 and 4 will be tracked. Students will also be asked to answer a post-test questionnaire designed to assess: i) the usability of this course ii) effectiveness of this course in helping students triage benign and malignant lesions. Usability will be assessed with the System Usability Scale. Effectiveness of the course will be assessed with questions tailored to assess the specific learning objectives.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • 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
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inclusion Criteria for Phase 1

Study participants must:

  1. be over the age of 18
  2. be currently a medical student , dermatology resident or member of the dermatology faculty at Northwestern University Feinberg School of Medicine

  3. able to consent

    Inclusion Criteria for Phase 2

    Study participants must:

  4. be over the age of 18
  5. be currently enrolled in an MD or PA course at Northwestern University Feinberg School of Medicine
  6. able to consent
  7. have internet access
  8. own and be able to use a smart phone
  9. be willing to participate in two online surveys before and after each simulation

Exclusion Criteria:

Exclusion Criteria for Phases 1 and 2

Participants will be excluded if:

  1. Not over 18 years of age
  2. Do not have internet access
  3. Do not have smart phone access
  4. Are not currently enrolled as MD or PA students

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Perceptual Training
Single-Arm study, all participants will receive educational training via online modules and will be assessed after completion of the training.
Other: Perceptual Training
Participants will assess skin lesions before and after completion of an online/mobile course that has the goal of learning to triage pigmented lesions as benign or malignant. Participants will also help evaluate the usability and effectiveness of the course by completing a questionnaire after completion of the course.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of Course
Time Frame: 18 months
Usability will be assessed with the System Usability Scale, a widely accepted and validated scale to assess consumer satisfaction with new products
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of Course
Time Frame: 18 months
Effectiveness of the course will be assessed with quiz requiring a benign or malignant decision about each image presents
18 months

Collaborators and Investigators

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

Sponsor

Northwestern 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)

August 10, 2017

Primary Completion (Actual)

February 6, 2018

Study Completion (Actual)

February 6, 2018

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 21, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • STU00205548

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.

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