Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488293
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2007-06-18
Brief Title:
Impact of Teledermatology on Health Services Outcomes in the Department of Veterans Affairs
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Impact of Teledermatology on Health Services Outcomes in the VA
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None