IMPORTANCE: New models of health care delivery for dermatological care have the potential to increase access and improve patient-centered outcomes. OBJECTIVE: To compare effectiveness of a direct-access, online model for follow-up dermatologic care in pediatric and adult patients with atopic dermatitis with that of in-person office visits. DESIGN, SETTING, AND PARTICIPANTS: This was a 1-year, randomized controlled equivalency clinical trial in medically underserved areas, outpatient clinics, and the general community. Participants included children and adults with atopic dermatitis with access to the Internet, computers, and digital cameras. INTERVENTIONS: After an initial in-person visit, patients were randomized 1:1 to direct-access online or usual in-person care for follow-up management of atopic dermatitis. In the direct-access online group, patients captured and transmitted clinical images and history asynchronously to dermatologists online; dermatologists evaluated the clinical information, provided recommendations and education, and prescribed medications online asynchronously. In the in-person group, patients visited dermatologists in their offices for follow-up care. MAIN OUTCOMES AND MEASURES: Atopic dermatitis disease severity as assessed by patient-oriented eczema measure (POEM) and investigator global assessment (IGA). RESULTS: A total of 156 children and adults were randomized. Between baseline and 12 months, the mean (SD) within-group difference in POEM score in patients in the direct-access online group was -5.1 (5.48) (95% CI, -6.32 to -3.88); in the in-person group, the within-group difference was -4.86 (4.87) (95% CI, -6.27 to -3.46). The difference in the change in POEM scores between the 2 groups was 0.24 (6.59) (90% CI, -1.70 to 1.23), which was contained within the predetermined 2.5 equivalence margin. The percentage of patients achieving clearance or near-clearance of their disease (IGA score of 0 or 1) was 38.4% (95% CI, 27.7% to 49.3%) in the direct-access online group and 43.6% (95% CI, 32.6%-54.6%) in the in-person group. The difference in the percent of patients achieving clearance or near-clearance between the 2 groups was 5.1% (90% CI, 1.7%-8.6%), which was contained within the predetermined 10% equivalence margin. CONCLUSIONS AND RELEVANCE: The direct-access online model results in equivalent improvements in atopic dermatitis clinical outcomes as in-person care. Direct-access online care may represent an innovative model of delivering dermatological services to patients with chronic skin diseases. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00985894.
RCT Entities:
IMPORTANCE: New models of health care delivery for dermatological care have the potential to increase access and improve patient-centered outcomes. OBJECTIVE: To compare effectiveness of a direct-access, online model for follow-up dermatologic care in pediatric and adult patients with atopic dermatitis with that of in-person office visits. DESIGN, SETTING, AND PARTICIPANTS: This was a 1-year, randomized controlled equivalency clinical trial in medically underserved areas, outpatient clinics, and the general community. Participants included children and adults with atopic dermatitis with access to the Internet, computers, and digital cameras. INTERVENTIONS: After an initial in-person visit, patients were randomized 1:1 to direct-access online or usual in-person care for follow-up management of atopic dermatitis. In the direct-access online group, patients captured and transmitted clinical images and history asynchronously to dermatologists online; dermatologists evaluated the clinical information, provided recommendations and education, and prescribed medications online asynchronously. In the in-person group, patients visited dermatologists in their offices for follow-up care. MAIN OUTCOMES AND MEASURES: Atopic dermatitis disease severity as assessed by patient-oriented eczema measure (POEM) and investigator global assessment (IGA). RESULTS: A total of 156 children and adults were randomized. Between baseline and 12 months, the mean (SD) within-group difference in POEM score in patients in the direct-access online group was -5.1 (5.48) (95% CI, -6.32 to -3.88); in the in-person group, the within-group difference was -4.86 (4.87) (95% CI, -6.27 to -3.46). The difference in the change in POEM scores between the 2 groups was 0.24 (6.59) (90% CI, -1.70 to 1.23), which was contained within the predetermined 2.5 equivalence margin. The percentage of patients achieving clearance or near-clearance of their disease (IGA score of 0 or 1) was 38.4% (95% CI, 27.7% to 49.3%) in the direct-access online group and 43.6% (95% CI, 32.6%-54.6%) in the in-person group. The difference in the percent of patients achieving clearance or near-clearance between the 2 groups was 5.1% (90% CI, 1.7%-8.6%), which was contained within the predetermined 10% equivalence margin. CONCLUSIONS AND RELEVANCE: The direct-access online model results in equivalent improvements in atopic dermatitis clinical outcomes as in-person care. Direct-access online care may represent an innovative model of delivering dermatological services to patients with chronic skin diseases. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00985894.
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