Impact of Teledermatology on Health Services Outcomes in the Department of Veterans Affairs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00488293
First received: June 18, 2007
Last updated: April 15, 2014
Last verified: April 2014

June 18, 2007
April 15, 2014
November 2008
February 2011   (final data collection date for primary outcome measure)
Quality of Life [ Time Frame: Baseline, Month 3, Month 9 ] [ Designated as safety issue: No ]
Quality of Life
Complete list of historical versions of study NCT00488293 on ClinicalTrials.gov Archive Site
Clinical course [ Time Frame: Baseline to Month 9 ] [ Designated as safety issue: No ]
Clinical course
Not Provided
Not Provided
 
Impact of Teledermatology on Health Services Outcomes in the Department of Veterans Affairs
Impact of Teledermatology on Health Services Outcomes in the VA

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.

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 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 asses 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Skin Diseases
  • Telemedicine
  • Quality of Life
Procedure: Store and forward teledermatology
Standard electronic consult, standardized history, and image set
Other Name: Teledermatology
  • Experimental: Arm 1
    Store and forward teledermatology consult process
    Intervention: Procedure: Store and forward teledermatology
  • No Intervention: Arm 2
    Conventional consult process

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
392
June 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00488293
IIR 05-278
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: John D. Whited, MD MHS Durham VA Medical Center, Durham, NC
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP