Trial Outcomes & Findings for Impact of Teledermatology on Health Services Outcomes in the Department of Veterans Affairs (NCT NCT00488293)

NCT ID: NCT00488293

Last Updated: 2015-06-08

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 392 participants
• Primary outcome timeframe: Baseline to Month 9
• Results posted on: 2015-06-08

Participant Flow

Recruitment occurred between 2008 and 2011.

Participant milestones

Measure	Teledermatology Referrals Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals Conventional consult process Conventional consult process: Standard electronic consult
Overall Study STARTED	196	196
Overall Study COMPLETED	160	166
Overall Study NOT COMPLETED	36	30

Reasons for withdrawal

Measure	Teledermatology Referrals Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals Conventional consult process Conventional consult process: Standard electronic consult
Overall Study Lost to Follow-up	28	25
Overall Study Withdrawal by Subject	5	3
Overall Study Death	2	1
Overall Study Misrandomization/Other Unspecified	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Teledermatology Referrals n=195 Participants Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals n=196 Participants Conventional consult process Conventional consult process: Standard electronic consult	Total n=391 Participants Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 14.9 • n=5 Participants	62.9 years STANDARD_DEVIATION 13.9 • n=7 Participants	62.3 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	190 Participants n=5 Participants	192 Participants n=7 Participants	382 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	193 Participants n=5 Participants	191 Participants n=7 Participants	384 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Month 9

Population: Baseline to Month 9 Skindex-16 change scores - 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.

Outcome measures

Measure	Teledermatology Referrals n=160 Participants Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals n=164 Participants Conventional consult process Conventional consult process: Standard electronic consult
Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score	-12.0 units on a scale Standard Deviation 24.5	-13.2 units on a scale Standard Deviation 21.6

PRIMARY outcome

Timeframe: Baseline to Month 3

Population: Baseline to Month 3 Skindex-16 change scores - 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.

Outcome measures

Measure	Teledermatology Referrals n=161 Participants Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals n=171 Participants Conventional consult process Conventional consult process: Standard electronic consult
Skindex-16 Change Scores Baseline to Month 3 - Composite Score	-7.8 units on a scale Standard Deviation 21.9	-5.8 units on a scale Standard Deviation 19.1

PRIMARY outcome

Timeframe: Baseline to Month 9

Population: Baseline to Month 9 Skindex-16 change scores - 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.

Outcome measures

Measure	Teledermatology Referrals n=159 Participants Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals n=164 Participants Conventional consult process Conventional consult process: Standard electronic consult
Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score	-10.3 units on a scale Standard Deviation 30.6	-14.4 units on a scale Standard Deviation 28.2

PRIMARY outcome

Timeframe: Baseline to Month 3

Population: Baseline to Month 3 Skindex-16 change score - 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.

Outcome measures

Measure	Teledermatology Referrals n=160 Participants Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals n=171 Participants Conventional consult process Conventional consult process: Standard electronic consult
Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score	-8.7 units on a scale Standard Deviation 29.8	-8.0 units on a scale Standard Deviation 22.9

PRIMARY outcome

Timeframe: Baseline to Month 9

Population: Baseline to Month 9 Skindex-16 change score - 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.

Outcome measures

Measure	Teledermatology Referrals n=160 Participants Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals n=164 Participants Conventional consult process Conventional consult process: Standard electronic consult
Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score	-19.7 units on a scale Standard Deviation 30.7	-18.1 units on a scale Standard Deviation 25.1

PRIMARY outcome

Timeframe: Baseline to Month 3

Population: Baseline to Month 3 Skindex-16 change scores - 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.

Outcome measures

Measure	Teledermatology Referrals n=160 Participants Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals n=171 Participants Conventional consult process Conventional consult process: Standard electronic consult
Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score	-11.6 units on a scale Standard Deviation 27.2	-8.9 units on a scale Standard Deviation 25.3

PRIMARY outcome

Timeframe: Baseline to Month 9

Population: Baseline to Month 9 Skindex-16 change scores - 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.

Outcome measures

Measure	Teledermatology Referrals n=160 Participants Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals n=164 Participants Conventional consult process Conventional consult process: Standard electronic consult
Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores	-6.0 units on a scale Standard Deviation 24.5	-6.9 units on a scale Standard Deviation 22.3

PRIMARY outcome

Timeframe: Baseline to Month 3

Population: Baseline to Month 3 Skindex-16 change scores - 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.

Outcome measures

Measure	Teledermatology Referrals n=160 Participants Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals n=164 Participants Conventional consult process Conventional consult process: Standard electronic consult
Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score	-3.2 units on a scale Standard Deviation 20.2	-0.5 units on a scale Standard Deviation 20.9

SECONDARY outcome

Timeframe: Baseline to Month 9

Population: 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.

Outcome measures

Measure	Teledermatology Referrals n=125 Participants Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals n=136 Participants Conventional consult process Conventional consult process: Standard electronic consult
Clinical Course Rating Between Baseline and Month 9 Improved	59 participants	63 participants
Clinical Course Rating Between Baseline and Month 9 Unchanged - Not Clinically Relevant	13 participants	15 participants
Clinical Course Rating Between Baseline and Month 9 Unchanged - Clinically Relevant	13 participants	17 participants
Clinical Course Rating Between Baseline and Month 9 Worse	9 participants	6 participants
Clinical Course Rating Between Baseline and Month 9 Resolved	31 participants	35 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Teledermatology Referrals n=94 Participants Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals n=137 Participants Conventional consult process Conventional consult process: Standard electronic consult
Clinical Course Rating Between Baseline and First Clinic Visit Unchanged - Clinically Relevant	54 participants	70 participants
Clinical Course Rating Between Baseline and First Clinic Visit Resolved	2 participants	3 participants
Clinical Course Rating Between Baseline and First Clinic Visit Improved	22 participants	29 participants
Clinical Course Rating Between Baseline and First Clinic Visit Unchanged - Not Clinically Relevant	10 participants	20 participants
Clinical Course Rating Between Baseline and First Clinic Visit Worse	6 participants	15 participants

Adverse Events

Teledermatology Referrals

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Conventional Referrals

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Teledermatology Referrals n=196 participants at risk Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals n=196 participants at risk Conventional consult process Conventional consult process: Standard electronic consult
General disorders Death Unrelated to Study Participation	1.0% 2/196 • Number of events 2	0.51% 1/196 • Number of events 1

Other adverse events

Measure	Teledermatology Referrals n=196 participants at risk Store and forward teledermatology consult process Store and forward teledermatology: Standard electronic consult, standardized history, and image set	Conventional Referrals n=196 participants at risk Conventional consult process Conventional consult process: Standard electronic consult
Skin and subcutaneous tissue disorders Wound Dehiscence	0.00% 0/196	0.51% 1/196 • Number of events 1
Skin and subcutaneous tissue disorders Rash from Sunscreen	0.51% 1/196 • Number of events 1	0.00% 0/196
Skin and subcutaneous tissue disorders Infection at Biopsy Site	0.00% 0/196	0.51% 1/196 • Number of events 1

Additional Information

John D. Whited, MD, MHS

Department of Veterans Affairs

Phone: 919-286-6926

Email: john.whited@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place