NCT01859845

Brief Summary

The specific aim of this study is to determine if interactive touchscreen-based learning with deliberate practice modules can enhance the retention of life-saving medical skills when incorporated into medical training curricula. We will analyze the retention and confidence of screening skills by comparing outcomes on pretest and posttest in each arm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 1, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

May 20, 2013

Last Update Submit

July 30, 2014

Conditions

Keywords

MelanomaOpportunistic surveillanceMelanoma simulation modelSmartphone devices

Outcome Measures

Primary Outcomes (1)

  • Evaluation of medical student's abilities to select pigmented lesions for review with dermoscopy on pre-didactic lecture test, pre-skills workshop test, and post-educational intervention test

    Retention will be measured using the percent of correctly identified benign nevi, clinically suspicious lesions, and melanomas identified by unaided visual inspection and the percent of correctly identified "benign" or "refer" lesions on dermoscopy images. The biopsy ratio of benign to malignant lesions will be also be assessed to determine the sensitivity and specificity outcomes of both study arms. Other outcomes measured are the confidence with identifying melanoma, attitudes toward melanoma screening, and recall of screening rules by participants. The rates of retention in both study arms will be compared on pre-workshop test and the post-test to determine if simulation learning modules positively impact learning and retention of skin screening.

    Two weeks post initial didactic education

Study Arms (2)

Control Study Arm

NO INTERVENTION

The control participants will first interact with the simulated melanoma back model to learn clinical unaided visual inspection skills and then view a passive image projected onto a screen for dermoscopy learning. Remediation of inappropriate clinical decisions will be carried out by the research coordinator and is based on predefined feedback consistent across both arms of the study. Along with the projected images, the coordinator will provide each control participant with worksheets for the clinical Asymmetry, Border, Color, Diameter (ABCD) and Dermoscopy 3-point check list. A copy of the completed worksheet will be made at the end of the workshop.

smartphone

EXPERIMENTAL

Each participant in the educational intervention arm will have access to a smartphone with a preloaded android software package. The smartphone software allows the participant to visualize a dermoscopic image of the pigmented lesion at the surface of the simulated melanoma model. Participants are given the freedom to navigate through the program via the smartphone to learn at their own pace with reinforcement of correct clinical management decisions and correction of weaknesses. The software content is limited to the dermoscopy information available to the positive control arm through the coordinator and the dermoscopic images projected onto the screen, thus a comparison of retention rates across both arms is possible.

Other: Smartphone

Interventions

Our team of dermatologists and biomechanical engineers led by the PI developed a simulation skills training prototype device using a smartphone. Software was developed to teach dermoscopic evaluation of pigmented lesions using the "three-poin checklist of dermoscopy". The software used in the smartphone presentation of the educational intervention also provides a decision tree of clinical management options and best-practices feedback. No patients are involved in this research.

Also known as: educational intervention
smartphone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Thirty 4th year medical students and 2nd year physician assistant (PA) students with previous experience with the Melanoma Simulation Model of the back (IRB STU00025072)
  • Eighty third-year medical students and thirty PA students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • June K Robinson, MD

    Northwestern University Department of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor of Dermatology

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 22, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 1, 2014

Record last verified: 2014-07

Locations