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: May 11, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Skin Diseases
Telemedicine
Quality of Life
Procedure: Store and forward teledermatology

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Teledermatology on Health Services Outcomes in the VA

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score [ Time Frame: Baseline to Month 9 ] [ Designated as safety issue: No ]
    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

  • Skindex-16 Change Scores Baseline to Month 3 - Composite Score [ Time Frame: Baseline to Month 3 ] [ Designated as safety issue: No ]
    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

  • Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score [ Time Frame: Baseline to Month 9 ] [ Designated as safety issue: No ]
    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

  • Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score [ Time Frame: Baseline to Month 3 ] [ Designated as safety issue: No ]
    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

  • Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score [ Time Frame: Baseline to Month 9 ] [ Designated as safety issue: No ]
    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

  • Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score [ Time Frame: Baseline to Month 3 ] [ Designated as safety issue: No ]
    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

  • Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores [ Time Frame: Baseline to Month 9 ] [ Designated as safety issue: No ]
    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

  • Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score [ Time Frame: Baseline to Month 3 ] [ Designated as safety issue: No ]
    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.


Secondary Outcome Measures:
  • Clinical Course Rating Between Baseline and Month 9 [ Time Frame: Baseline to Month 9 ] [ Designated as safety issue: No ]
    Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.

  • Clinical Course Rating Between Baseline and First Clinic Visit [ Time Frame: Baseline to First Clinic Visit ] [ Designated as safety issue: No ]
    Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.


Enrollment: 392
Study Start Date: November 2008
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Store and forward teledermatology consult process
Procedure: Store and forward teledermatology
Standard electronic consult, standardized history, and image set
Other Name: Teledermatology
No Intervention: Arm 2
Conventional consult process

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488293

Locations
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Harry S. Truman Memorial, Columbia, MO
Columbia, Missouri, United States, 65201-5297
Sponsors and Collaborators
Investigators
Principal Investigator: John D. Whited, MD MHS Harry S. Truman Memorial, Columbia, MO
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00488293     History of Changes
Other Study ID Numbers: IIR 05-278
Study First Received: June 18, 2007
Results First Received: November 3, 2014
Last Updated: May 11, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Telemedicine
Skin diseases
Dermatology
Quality of life
Economics

Additional relevant MeSH terms:
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2015