Quality of Life, Skin Diseases, Telemedicine
Conditions
Keywords
Telemedicine, Skin diseases, Dermatology, Quality of life, Economics
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.
Interventions
PROCEDUREStore and forward teledermatology
Standard electronic consult, standardized history, and image set
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score | Baseline to Month 3 | 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 | Baseline to Month 3 | 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 | Baseline to Month 9 | 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 9 - Composite Score | Baseline to Month 9 | 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 | Baseline to Month 3 | 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 | Baseline to Month 9 | 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 | Baseline to Month 3 | 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 | Baseline to Month 9 | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Course Rating Between Baseline and First Clinic Visit | Baseline to 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 Month 9 | Baseline to 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between 2008 and 2011.
Participants by arm
| Arm | Count |
|---|---|
| Teledermatology Referrals Store and forward teledermatology consult process
Store and forward teledermatology: Standard electronic consult, standardized history, and image set | 195 |
| Conventional Referrals Conventional consult process
Conventional consult process: Standard electronic consult | 196 |
| Total | 391 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 28 | 25 |
| Overall Study | Misrandomization/Other Unspecified | 1 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 3 |
Baseline characteristics
| Characteristic | Teledermatology Referrals | Conventional Referrals | Total |
|---|---|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 14.9 | 62.9 years STANDARD_DEVIATION 13.9 | 62.3 years STANDARD_DEVIATION 14.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 193 Participants | 191 Participants | 384 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 190 Participants | 192 Participants | 382 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 196 | 2 / 196 |
| serious Total, serious adverse events | 2 / 196 | 1 / 196 |
Outcome results
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.
Time frame: Baseline to Month 3
Population: Baseline to Month 3 Skindex-16 change scores - Composite Score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teledermatology Referrals | Skindex-16 Change Scores Baseline to Month 3 - Composite Score | -7.8 units on a scale | Standard Deviation 21.9 |
| Conventional Referrals | Skindex-16 Change Scores Baseline to Month 3 - Composite Score | -5.8 units on a scale | Standard Deviation 19.1 |
p-value: 0.39t-test, 2 sided
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.
Time frame: Baseline to Month 9
Population: Baseline to Month 9 Skindex-16 change scores - Symptoms Score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teledermatology Referrals | Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score | -10.3 units on a scale | Standard Deviation 30.6 |
| Conventional Referrals | Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score | -14.4 units on a scale | Standard Deviation 28.2 |
p-value: 0.22t-test, 2 sided
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.
Time frame: Baseline to Month 3
Population: Baseline to Month 3 Skindex-16 change scores - Functioning Scores
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teledermatology Referrals | Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score | -3.2 units on a scale | Standard Deviation 20.2 |
| Conventional Referrals | Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score | -0.5 units on a scale | Standard Deviation 20.9 |
p-value: 0.22t-test, 2 sided
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.
Time frame: Baseline to Month 9
Population: Baseline to Month 9 Skindex-16 change score - Emotions Score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teledermatology Referrals | Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score | -19.7 units on a scale | Standard Deviation 30.7 |
| Conventional Referrals | Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score | -18.1 units on a scale | Standard Deviation 25.1 |
p-value: 0.61t-test, 2 sided
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.
Time frame: Baseline to Month 9
Population: Baseline to Month 9 Skindex-16 change scores - Functioning Scores
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teledermatology Referrals | Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores | -6.0 units on a scale | Standard Deviation 24.5 |
| Conventional Referrals | Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores | -6.9 units on a scale | Standard Deviation 22.3 |
p-value: 0.73t-test, 2 sided
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.
Time frame: Baseline to Month 3
Population: Baseline to Month 3 Skindex-16 change scores - Emotions Score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teledermatology Referrals | Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score | -11.6 units on a scale | Standard Deviation 27.2 |
| Conventional Referrals | Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score | -8.9 units on a scale | Standard Deviation 25.3 |
p-value: 0.36t-test, 2 sided
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.
Time frame: Baseline to Month 9
Population: Baseline to Month 9 Skindex-16 change scores - Composite Score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teledermatology Referrals | Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score | -12.0 units on a scale | Standard Deviation 24.5 |
| Conventional Referrals | Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score | -13.2 units on a scale | Standard Deviation 21.6 |
p-value: 0.66t-test, 2 sided
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.
Time frame: Baseline to Month 3
Population: Baseline to Month 3 Skindex-16 change score - Symptoms Score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teledermatology Referrals | Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score | -8.7 units on a scale | Standard Deviation 29.8 |
| Conventional Referrals | Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score | -8.0 units on a scale | Standard Deviation 22.9 |
p-value: 0.81t-test, 2 sided
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.
Time frame: Baseline to First Clinic Visit
Population: Clinical course rating between baseline and first clinic visit, if a visit occurred. Timeframe varied and only applied if a first clinic visit occurred.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teledermatology Referrals | Clinical Course Rating Between Baseline and First Clinic Visit | Improved | 22 participants |
| Teledermatology Referrals | Clinical Course Rating Between Baseline and First Clinic Visit | Unchanged - Clinically Relevant | 54 participants |
| Teledermatology Referrals | Clinical Course Rating Between Baseline and First Clinic Visit | Unchanged - Not Clinically Relevant | 10 participants |
| Teledermatology Referrals | Clinical Course Rating Between Baseline and First Clinic Visit | Worse | 6 participants |
| Teledermatology Referrals | Clinical Course Rating Between Baseline and First Clinic Visit | Resolved | 2 participants |
| Conventional Referrals | Clinical Course Rating Between Baseline and First Clinic Visit | Worse | 15 participants |
| Conventional Referrals | Clinical Course Rating Between Baseline and First Clinic Visit | Resolved | 3 participants |
| Conventional Referrals | Clinical Course Rating Between Baseline and First Clinic Visit | Improved | 29 participants |
| Conventional Referrals | Clinical Course Rating Between Baseline and First Clinic Visit | Unchanged - Not Clinically Relevant | 20 participants |
| Conventional Referrals | Clinical Course Rating Between Baseline and First Clinic Visit | Unchanged - Clinically Relevant | 70 participants |
p-value: 0.65Chi-squared
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.
Time frame: Baseline to Month 9
Population: Clinical course rating between baseline and month 9
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teledermatology Referrals | Clinical Course Rating Between Baseline and Month 9 | Resolved | 31 participants |
| Teledermatology Referrals | Clinical Course Rating Between Baseline and Month 9 | Unchanged - Not Clinically Relevant | 13 participants |
| Teledermatology Referrals | Clinical Course Rating Between Baseline and Month 9 | Improved | 59 participants |
| Teledermatology Referrals | Clinical Course Rating Between Baseline and Month 9 | Unchanged - Clinically Relevant | 13 participants |
| Teledermatology Referrals | Clinical Course Rating Between Baseline and Month 9 | Worse | 9 participants |
| Conventional Referrals | Clinical Course Rating Between Baseline and Month 9 | Unchanged - Clinically Relevant | 17 participants |
| Conventional Referrals | Clinical Course Rating Between Baseline and Month 9 | Worse | 6 participants |
| Conventional Referrals | Clinical Course Rating Between Baseline and Month 9 | Resolved | 35 participants |
| Conventional Referrals | Clinical Course Rating Between Baseline and Month 9 | Improved | 63 participants |
| Conventional Referrals | Clinical Course Rating Between Baseline and Month 9 | Unchanged - Not Clinically Relevant | 15 participants |
p-value: 0.88Chi-squared