Perceptual Expertise Training for Triage of Moles

Diagnostic Self Evaluation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246633
• Other study ID #: STU00205548
• Status: Completed
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: February 6, 2018

Study information

• Verified date: September 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: February 6, 2018
• Est. primary completion date: February 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnostic Self Evaluation
• Lesion; Pigment

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (17)

Avilés-Izquierdo JA, Molina-López I, Rodríguez-Lomba E, Marquez-Rodas I, Suarez-Fernandez R, Lazaro-Ochaita P. Who detects melanoma? Impact of detection patterns on characteristics and prognosis of patients with melanoma. J Am Acad Dermatol. 2016 Nov;75(5):967-974. doi: 10.1016/j.jaad.2016.07.009. Epub 2016 Sep 16. — View Citation

Brochez L, Verhaeghe E, Bleyen L, Naeyaert JM. Diagnostic ability of general practitioners and dermatologists in discriminating pigmented skin lesions. J Am Acad Dermatol. 2001 Jun;44(6):979-86. — View Citation

Brooke, J., SUS: A

Cassileth BR, Clark WH Jr, Lusk EJ, Frederick BE, Thompson CJ, Walsh WP. How well do physicians recognize melanoma and other problem lesions? J Am Acad Dermatol. 1986 Apr;14(4):555-60. — View Citation

Eide MJ, Asgari MM, Fletcher SW, Geller AC, Halpern AC, Shaikh WR, Li L, Alexander GL, Altschuler A, Dusza SW, Marghoob AA, Quigley EA, Weinstock MA; INFORMED (INternet course FOR Melanoma Early Detection) Group. Effects on skills and practice from a web-based skin cancer course for primary care providers. J Am Board Fam Med. 2013 Nov-Dec;26(6):648-57. doi: 10.3122/jabfm.2013.06.130108. — View Citation

Garg A, Wang J, Reddy SB, Powers J, Jacob R, Powers M, Biello K, Cayce R, Savory S, Belazarian L, Domingues E, Korzenko A, Wilson L, Grant-Kels JM, George P, Robinson-Bostom L, Trotter SC, Geller AC. The Integrated Skin Exam film: an educational intervention to promote early detection of melanoma by medical students. J Am Acad Dermatol. 2014 Jan;70(1):115-9. doi: 10.1016/j.jaad.2013.09.028. Epub 2013 Nov 9. — View Citation

Herschorn A. Dermoscopy for melanoma detection in family practice. Can Fam Physician. 2012 Jul;58(7):740-5, e372-8. Review. English, French. — View Citation

Jain N, Anderson MJ, Patel P, Blatt H, Davis L, Bierman J, McGaghie W, Brucker JB, Martini M, Robinson JK. Melanoma simulation model: promoting opportunistic screening and patient counseling. JAMA Dermatol. 2013 Jun;149(6):710-6. doi: 10.1001/jamadermatol.2013.2882. — View Citation

Lofgreen S, Lehrer M, Bennett P, Garg A, Dunnick CA. Integrating The Integrated Skin Exam film into medical education. Dermatol Online J. 2016 Nov 15;22(11). pii: 13030/qt5pk3n658. — View Citation

Oliveria SA, Heneghan MK, Cushman LF, Ughetta EA, Halpern AC. Skin cancer screening by dermatologists, family practitioners, and internists: barriers and facilitating factors. Arch Dermatol. 2011 Jan;147(1):39-44. doi: 10.1001/archdermatol.2010.414. — View Citation

Reed KB, Brewer JD, Lohse CM, Bringe KE, Pruitt CN, Gibson LE. Increasing incidence of melanoma among young adults: an epidemiological study in Olmsted County, Minnesota. Mayo Clin Proc. 2012 Apr;87(4):328-34. doi: 10.1016/j.mayocp.2012.01.010. — View Citation

Scope A, Dusza SW, Halpern AC, Rabinovitz H, Braun RP, Zalaudek I, Argenziano G, Marghoob AA. The "ugly duckling" sign: agreement between observers. Arch Dermatol. 2008 Jan;144(1):58-64. doi: 10.1001/archdermatol.2007.15. — View Citation

Society, A.C. Melanoma Skin Cancer. 2016.

Society, A.C. Skin Exams. 2016.

Summaries for patients. Screening for skin cancer: U.S. Preventive Services Task Force recommendation. Ann Intern Med. 2009 Feb 3;150(3):I40. — View Citation

Thomas L, Tranchand P, Berard F, Secchi T, Colin C, Moulin G. Semiological value of ABCDE criteria in the diagnosis of cutaneous pigmented tumors. Dermatology. 1998;197(1):11-7. — View Citation

Wender RC. Barriers to effective skin cancer detection. Cancer. 1995 Jan 15;75(2 Suppl):691-8. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability of Course	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	Effectiveness of Course	Effectiveness of the course will be assessed with quiz requiring a benign or malignant decision about each image presents	18 months