Trial Outcomes & Findings for The Impact of a Dermatology Information Source on Skin Problem Outcomes in Primary Care (NCT NCT02922738)
NCT ID: NCT02922738
Last Updated: 2019-07-30
Results Overview
Resolved skin disease status was assessed by phone interview. Patient reported status. Patients were censored if "unresolved" at 90 days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
465 participants
Primary outcome timeframe
Period of assessment was up to 3 months (90 days) after index visit.
Results posted on
2019-07-30
Participant Flow
Provider recruitment by email invitation to Family Medicine and Adult Medicine providers at one academic medical center. 32 primary care providers (PCPs) enrolled. 989 patients with a skin problem visit to a participating PCP were identified between November 2015 to August, 2016. 433 patients participated by providing data in telephone interviews.
Participant milestones
| Measure |
Intervention - VisualDx Arm
Providers (clusters) randomized to use VisualDx when seeing a patient that presented with a skin problem. Their patients, seen for a skin problem were interviewed for outcome data.
|
Control: Usual Care Arm
Control providers (clusters) did not use VisualDx but could refer to other information sources or none in usual care.
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
290
|
|
Overall Study
COMPLETED
|
175
|
290
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data were collected for patients only.
Baseline characteristics by cohort
| Measure |
Intervention - VisualDx Arm
n=175 Participants
Providers referred to VisualDx when seeing a patient with a skin problem. Patients with skin problem were interviewed for outcomes data.
|
Control - Usual Care Arm
n=290 Participants
Providers ddi not refer to VisualDx but could refer to other resources or none per usual care.
|
Total
n=465 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=158 Participants • Age data were collected for patients only.
|
58 years
n=275 Participants • Age data were collected for patients only.
|
58 years
n=433 Participants • Age data were collected for patients only.
|
|
Sex: Female, Male
Patients · Female
|
80 Participants
n=157 Participants • 2 patients, 1 intervention and 1 control, did not provide sex data.
|
137 Participants
n=274 Participants • 2 patients, 1 intervention and 1 control, did not provide sex data.
|
217 Participants
n=431 Participants • 2 patients, 1 intervention and 1 control, did not provide sex data.
|
|
Sex: Female, Male
Patients · Male
|
77 Participants
n=157 Participants • 2 patients, 1 intervention and 1 control, did not provide sex data.
|
137 Participants
n=274 Participants • 2 patients, 1 intervention and 1 control, did not provide sex data.
|
214 Participants
n=431 Participants • 2 patients, 1 intervention and 1 control, did not provide sex data.
|
|
Sex: Female, Male
Providers · Female
|
7 Participants
n=17 Participants • 2 patients, 1 intervention and 1 control, did not provide sex data.
|
8 Participants
n=15 Participants • 2 patients, 1 intervention and 1 control, did not provide sex data.
|
15 Participants
n=32 Participants • 2 patients, 1 intervention and 1 control, did not provide sex data.
|
|
Sex: Female, Male
Providers · Male
|
10 Participants
n=17 Participants • 2 patients, 1 intervention and 1 control, did not provide sex data.
|
7 Participants
n=15 Participants • 2 patients, 1 intervention and 1 control, did not provide sex data.
|
17 Participants
n=32 Participants • 2 patients, 1 intervention and 1 control, did not provide sex data.
|
|
Region of Enrollment
United States
|
175 Participants
n=175 Participants
|
290 Participants
n=290 Participants
|
465 Participants
n=465 Participants
|
PRIMARY outcome
Timeframe: Period of assessment was up to 3 months (90 days) after index visit.Population: Number of patient participants only (excludes providers)
Resolved skin disease status was assessed by phone interview. Patient reported status. Patients were censored if "unresolved" at 90 days.
Outcome measures
| Measure |
Intervention - Used VisualDx
n=158 Participants
Providers referred to VisualDx when seeing a patient that presented with a skin problem. Patients were interviewed about the outcome of their treatment. Patients were allocated to the randomization group of the PCP they saw.
VisualDx: VisualDx is a computerized clinical information technology with medical image and text content in dermatology.
|
Control - Usual Care
n=275 Participants
Providers did not use VisualDx but may have referred to other information sources or none (usual care). Patients were allocated to the randomization group of the PCP they saw.Patients were interviewed about the outcome of their treatment.
|
|---|---|---|
|
Number of Patients With Resolved Skin Problems
|
72 Participants
|
135 Participants
|
PRIMARY outcome
Timeframe: Period of Assessment is up to 90 days after index visitFollow-up visits count is assessed at each phone interview. Patients report return visits.
Outcome measures
| Measure |
Intervention - Used VisualDx
n=158 Participants
Providers referred to VisualDx when seeing a patient that presented with a skin problem. Patients were interviewed about the outcome of their treatment. Patients were allocated to the randomization group of the PCP they saw.
VisualDx: VisualDx is a computerized clinical information technology with medical image and text content in dermatology.
|
Control - Usual Care
n=275 Participants
Providers did not use VisualDx but may have referred to other information sources or none (usual care). Patients were allocated to the randomization group of the PCP they saw.Patients were interviewed about the outcome of their treatment.
|
|---|---|---|
|
Number of Follow-Up Visits to Any Provider for the Same Problem
|
0.65 Return Appointments
Interval 0.0 to 7.0
|
0.55 Return Appointments
Interval 0.0 to 7.0
|
Adverse Events
Intervention - Used VisualDx
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place