Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event

The purpose of this study is to determine the diagnostic and management concordance of face-to-face dermatologist versus a store-and-forward teledermatologist at a skin cancer screening event.

The investigators' hypotheses include the following:

1. Compared to in-person assessment, store-and-forward teledermatology assessment will result in adequate diagnostic concordance.
2. Compared to in-person assessment, store-and-forward teledermatology results in adequate management concordance.
3. The sensitivity and specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant will be similar to that of in-person evaluation.

Study Overview

• Status: Completed
• Conditions: Telemedicine; Skin Cancer; Screening
• Intervention / Treatment: Other: In-person dermatology evaluation; Other: Store-and-forward teledermatology evaluation

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95818
      • University of California, Davis Shifa Community Clinic

Participation Criteria

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:

• 18 years of age or older at time of consent, may be male or female.
• Able to provide a brief medical history and have/allow an examination of their skin including photographs.
• Capable of giving informed consent.
• Will be able to receive notification of follow-up recommendations

Exclusion Criteria:

• Patients who will not provide informed consent
• Patient who are unable to fulfill tasks of this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: In-person dermatology evaluation; Health care modality	Other: In-person dermatology evaluation; Every patient will be evaluated by an in person dermatologist present at the screening.
OTHER: Store-and-forward teledermatology evaluation; Health care modality	Other: Store-and-forward teledermatology evaluation; Every patient will be evaluated online via a store and forward teledermatology modality.; Other Names: Health care modality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aggregated diagnostic concordance	Aggregated diagnostic concordance which is defined as the agreement of the in-person dermatologist's principle diagnosis with the teledermatologist's primary diagnosis or any of the differential diagnoses.	At the time of dermatologist evaluation (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary diagnostic concordance	Diagnostic concordance between the in-person dermatologist and the teledermatologist for their primary diagnosis.	At the time of dermatologist evaluation (Day 1)
Categorical diagnostic concordance	Diagnostic concordance between the in-person dermatologist and teledermatologist based on standard clinical diagnostic categories for each lesion.	At the time of dermatologist evaluation (Day 1)
Management concordance	The concordance between the in-person dermatologist and teledermatologist for the chosen management plan for each lesion.	At the time of dermatologist evaluation (Day 1)
Sensitivity	The sensitivity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.	At the time of dermatologist evaluation (Day 1)
Specificity	The specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.	At the time of dermatologist evaluation (Day 1)

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: April W Armstrong, MD, MPH, University of California, Davis

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: March 25, 2013
• First Posted (ESTIMATE): March 28, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Screening; Skin cancer; Teledermatology; Store-and-forward
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: 201018315