Clinical trial NCT00488293: Impact of Teledermatology on Health Services Outcomes in the Department of Veterans Affairs
Official title: Impact of Teledermatology on Health Services Outcomes in the VA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Diseases
Telemedicine
Quality of Life
Keywords: Telemedicine
Skin diseases
Dermatology
Quality of life
Economics
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2007-06-20
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares store and forward teledermatology with the conventional clinic-based consult process. Our primary objective is to determine whether the mean change in quality of life, as rated by the subscale scores and composite score on the Skindex-16 differs between the store and forward and conventional care modalities.

Detailed description: Anticipated Impact on Veterans' Healthcare - Teledermatology has the potential to have a significant impact on veterans' healthcare. There is an unmet demand for Dermatology services distributed throughout a nation-wide patient base. Decentralization of care through the expansion of Community Based Outpatient Centers (CBOCs) adds to the demand for these services. Dermatologic care typically resides only at the largest medical centers within a Veterans Integrated Service Network (VISN). Teledermatology is one means of meeting the demand for Dermatology services by delivering dermatologic care to those sites that are geographically removed from the Dermatology Consult Service.

Project Background - For the majority of ambulatory skin conditions encountered in Primary Care and Dermatology Clinics the impact those conditions have on patients' quality of life is of principal importance. Commonly encountered skin diseases frequently result in discomfort or pain, pruritis, emotional concerns, embarrassment, anxiety, and interfere with activities of daily living, work activities, or interpersonal relations. To date, no data exist that compares quality of life outcomes - the fundamental metric to assess in an ambulatory dermatology population - between patients undergoing store and forward teledermatology consultations with patients managed by the conventional consult processes. Existing data does indicate that teledermatology is a reliable and accurate method of diagnosing skin disease.

Research Objectives - The purpose of this study was to compare store and forward teledermatology with a conventional clinic-based dermatology consultation process. Our primary objective was to determine whether the mean change in patient quality of life, as rated by the composite score and subscale scores of a skin-specific quality of life index (Skindex-16), differed between the time of randomization and 9 months for patients evaluated by store and forward teledermatology compared to conventional consult methods. Secondary objectives included (a) assessing quality of life between time of randomization and 3 months, (b) assessing time to initial definitive evaluation for patients using each modality, (c) evaluating clinical course using serial digital imaging, (d) comparing the costs and cost-effectiveness of store and forward teledermatology with conventional consult methods.

Project Methods - The study was a parallel-group, superiority, randomized clinical trial that compared store and forward teledermatology with a conventional clinic-based consult process. Patients were randomized using a simple randomization scheme stratified by site to one of the two consult modalities. Eligible patients included those being referred from the remote sites of primary care to the medical center-based sites of dermatology services. Skindex-16 was administered at baseline, 3 months, and 9 months. Time to initial definitive evaluation, calculated based on the need for and timing of a clinic-based visit was measured for both groups. Using digital images, clinical course was assessed on a 5 point scale by an expert panel of three dermatologists. Categories included resolved, improved, unchanged not clinically relevant, unchanged clinically relevant, and worse. Health care utilities were measured using time trade-off data and the Health Utilities Index Mark 2 (HUI2). We compared the costs of teledermatology with conventional consult methods by estimating the average cost per patient over the 9 month study period. Effectiveness was assessed using health care utilities and time to initial definitive evaluation. Costs were estimated from the VA perspective.

Eligibility criteria: Inclusion Criteria:

* Patients with a single non-emergent skin condition being referred to a VA Dermatology Clinic
* Must be a veteran at the study site

Exclusion Criteria:

* Full body examination requested
* Unable to read or speak English
* Emergent skin condition
* Pending dermatology appointment within 9 months
* Previous enrollment in the study
* Impending move from the area

Primary outcomes:
measure: Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score
timeFrame: Baseline to Month 9
measure: Skindex-16 Change Scores Baseline to Month 3 - Composite Score
timeFrame: Baseline to Month 3
measure: Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score
timeFrame: Baseline to Month 9
measure: Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score
timeFrame: Baseline to Month 3
measure: Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score
timeFrame: Baseline to Month 9
measure: Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score
timeFrame: Baseline to Month 3
measure: Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores
timeFrame: Baseline to Month 9
measure: Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score
timeFrame: Baseline to Month 3
Secondary outcomes:
measure: Clinical Course Rating Between Baseline and Month 9
timeFrame: Baseline to Month 9
measure: Clinical Course Rating Between Baseline and First Clinic Visit
timeFrame: Baseline to First Clinic Visit
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Columbia
country: United States
facility: Harry S. Truman Memorial, Columbia, MO
state: Missouri
Study officials:
affiliation: Harry S. Truman Memorial, Columbia, MO
name: John D. Whited, MD MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whited JD, Warshaw EM, Edison KE, Kapur K, Thottapurathu L, Raju S, Cook B, Engasser H, Pullen S, Parks P, Sindowski T, Motyka D, Brown R, Moritz TE, Datta SK, Chren MM, Marty L, Reda DJ. Effect of store and forward teledermatology on quality of life: a randomized controlled trial. JAMA Dermatol. 2013 May;149(5):584-91. doi: 10.1001/2013.jamadermatol.380.
citation: Whited JD, Warshaw EM, Kapur K, Edison KE, Thottapurathu L, Raju S, Cook B, Engasser H, Pullen S, Moritz TE, Datta SK, Marty L, Foman NA, Suwattee P, Ward DS, Reda DJ. Clinical course outcomes for store and forward teledermatology versus conventional consultation: a randomized trial. J Telemed Telecare. 2013 Jun;19(4):197-204. doi: 10.1177/1357633x13487116. Epub 2013 May 23.
citation: Datta SK, Warshaw EM, Edison KE, Kapur K, Thottapurathu L, Moritz TE, Reda DJ, Whited JD. Cost and Utility Analysis of a Store-and-Forward Teledermatology Referral System: A Randomized Clinical Trial. JAMA Dermatol. 2015 Dec 1;151(12):1323-1329. doi: 10.1001/jamadermatol.2015.2362.