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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Store and forward teledermatology consult process |
|
| Arm 2 | No Intervention | Conventional consult process |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Store and forward teledermatology | Procedure | Standard electronic consult, standardized history, and image set |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score | 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. | Baseline to Month 9 |
| Skindex-16 Change Scores Baseline to Month 3 - Composite Score | 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. | Baseline to Month 3 |
| Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score | 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. | Baseline to Month 9 |
| Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Course Rating Between Baseline and Month 9 | 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. | Baseline to Month 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John D. Whited, MD MHS | Harry S. Truman Memorial, Columbia, MO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417 | United States | ||
| Harry S. Truman Memorial, Columbia, MO |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23426111 | Background | 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. | |
| 23666440 |
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Recruitment occurred between 2008 and 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teledermatology Referrals | Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set |
| FG001 | Conventional Referrals | Conventional consult process Conventional consult process: Standard electronic consult |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One patient assigned to teledermatology was misrandomized and not included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Teledermatology Referrals | Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set |
| BG001 | Conventional Referrals |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score | 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. | Baseline to Month 9 Skindex-16 change scores - Composite Score. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Month 9 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teledermatology Referrals | Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death Unrelated to Study Participation | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Dehiscence | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John D. Whited, MD, MHS | Department of Veterans Affairs | 919-286-6926 | john.whited@va.gov |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| Baseline to Month 3 |
| Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score | 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. | Baseline to Month 9 |
| Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score | 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. | Baseline to Month 3 |
| Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores | 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. | Baseline to Month 9 |
| Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score | 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. | Baseline to Month 3 |
| Clinical Course Rating Between Baseline and First Clinic Visit | 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. | Baseline to First Clinic Visit |
| Columbia |
| Missouri |
| 65201-5297 |
| United States |
| 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. |
| 26375589 | Derived | 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. |
| Death |
|
| Misrandomization/Other Unspecified |
|
Conventional consult process
Conventional consult process: Standard electronic consult
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Conventional Referrals | Conventional consult process Conventional consult process: Standard electronic consult |
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| Secondary | Clinical Course Rating Between Baseline and Month 9 | 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 month 9 | Posted | Number | participants | Baseline to Month 9 |
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| Primary | Skindex-16 Change Scores Baseline to Month 3 - Composite Score | 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. | Baseline to Month 3 Skindex-16 change scores - Composite Score | Posted | Mean | Standard Deviation | units on a scale | Baseline to Month 3 |
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| Primary | Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score | 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. | Baseline to Month 9 Skindex-16 change scores - Symptoms Score | Posted | Mean | Standard Deviation | units on a scale | Baseline to Month 9 |
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| Primary | Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score | 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. | Baseline to Month 3 Skindex-16 change score - Symptoms Score | Posted | Mean | Standard Deviation | units on a scale | Baseline to Month 3 |
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| Primary | Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score | 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. | Baseline to Month 9 Skindex-16 change score - Emotions Score | Posted | Mean | Standard Deviation | units on a scale | Baseline to Month 9 |
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| Primary | Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score | 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. | Baseline to Month 3 Skindex-16 change scores - Emotions Score | Posted | Mean | Standard Deviation | units on a scale | Baseline to Month 3 |
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| Primary | Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores | 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. | Baseline to Month 9 Skindex-16 change scores - Functioning Scores | Posted | Mean | Standard Deviation | units on a scale | Baseline to Month 9 |
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| Primary | Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score | 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. | Baseline to Month 3 Skindex-16 change scores - Functioning Scores | Posted | Mean | Standard Deviation | units on a scale | Baseline to Month 3 |
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| Secondary | Clinical Course Rating Between Baseline and First Clinic Visit | 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, if a visit occurred. Timeframe varied and only applied if a first clinic visit occurred. | Posted | Number | participants | Baseline to First Clinic Visit |
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| 2 |
| 196 |
| 1 |
| 196 |
| EG001 | Conventional Referrals | Conventional consult process Conventional consult process: Standard electronic consult | 1 | 196 | 2 | 196 |
| Rash from Sunscreen | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Infection at Biopsy Site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Unchanged - Not Clinically Relevant |
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| Unchanged - Clinically Relevant |
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| Worse |
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| Unchanged - Not Clinically Relevant |
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| Unchanged - Clinically Relevant |
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| Worse |
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