Clinical trial NCT03246633: Perceptual Expertise Training for Triage of Moles
Official title: Perceptual Training to Improve Early Detection of Melanoma by Future Healthcare Providers: to Accuarate Triage of Benign vs. Malignant Pigmented Skin Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lesion; Pigment
Diagnostic Self Evaluation
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Usability of Course
timeFrame: 18 months
Secondary outcomes:
measure: Effectiveness of Course
timeFrame: 18 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
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