Effectiveness of Online vs In-Person Care for Adults With Psoriasis: A Randomized Clinical Trial

Abstract

Importance: Innovative, online models of specialty-care delivery are critical to improving patient access and outcomes.

Objective: To determine whether an online, collaborative connected-health model results in equivalent clinical improvements in psoriasis compared with in-person care.

Design, setting, and participants: The Patient-Centered Outcomes Research Institute Psoriasis Teledermatology Trial is a 12-month, pragmatic, randomized clinical equivalency trial to evaluate the effect of an online model for psoriasis compared with in-person care. Participant recruitment and study visits took place at multicenter ambulatory clinics from February 2, 2015, to August 18, 2017. Participants were adults with psoriasis in Northern California, Southern California, and Colorado. The eligibility criteria were an age of 18 years or older, having physician-diagnosed psoriasis, access to the internet and a digital camera or mobile phone with a camera, and having a primary care physician. Analyses were on an intention-to-treat basis.

Interventions: Participants were randomized 1:1 to receive online or in-person care (148 randomized to online care and 148 randomized to in-person care). The online model enabled patients and primary care physicians to access dermatologists online asynchronously. The dermatologists provided assessments, recommendations, education, and prescriptions online. The in-person group sought care in person. The frequency of online or in-person visits was determined by medical necessity. All participants were exposed to their respective interventions for 12 months.

Main outcomes and measures: The prespecified primary outcome was the difference in improvement in the self-administered Psoriasis Area and Severity Index (PASI) score between the online and in-person groups. Prespecified secondary outcomes included body surface area (BSA) affected by psoriasis and the patient global assessment score.

Results: Of the 296 randomized participants, 147 were women, 149 were men, 187 were white, and the mean (SD) age was 49 (14) years. The adjusted difference between the online and in-person groups in the mean change in the self-administered PASI score during the 12-month study period was -0.27 (95% CI, -0.85 to 0.31). The difference in the mean change in BSA affected by psoriasis between the 2 groups was -0.05% (95% CI, -1.58% to 1.48%). Between-group differences in the PASI score and BSA were within prespecified equivalence margins, which demonstrated equivalence between the 2 interventions. The difference in the mean change in the patient global assessment score between the 2 groups was -0.11 (95% CI, -0.32 to 0.10), which exceeded the equivalence margin, with the online group displaying greater improvement.

Conclusions and relevance: The online, collaborative connected-health model was as effective as in-person management in improving clinical outcomes among patients with psoriasis. Innovative telehealth delivery models that emphasize collaboration, quality, and efficiency can be transformative to improving patient-centered outcomes in chronic diseases.

Trial registration: ClinicalTrials.gov Identifier: NCT02358135.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Armstrong reported serving as an investigator, consultant, advisor, and/or speaker for AbbVie, Janssen, Lilly, Novartis, Sanofi, Regeneron, Leo, Science 37, Modmed, Pfizer, Ortho Dermatologics, and Modernizing Medicine. Dr Gelfand reported serving as a consultant for and receiving honoraria from BMS, Coherus (DSMB), Dermira, GSK, Janssen Biologics, Menlo Therapeutics, Novartis Corp, Regeneron, Dr Reddy’s Laboratories, Sanofi, and Pfizer Inc; receiving research grants (to the Trustees of the University of Pennsylvania) from AbbVie, Janssen, Novartis Corp, Regeneron, Sanofi, Celgene, Ortho Dermatologics, and Pfizer Inc; receiving payment for continuing medical education work related to psoriasis that was supported indirectly by Lilly, Ortho Dermatologics, and AbbVie; and being a co–patent holder of resiquimod for treatment of cutaneous T-cell lymphoma. Dr Wong reported being an employee of DirectDerm. No other disclosures were reported.

Figures

Figure 1.. CONSORT Flow Diagram

Figure 2.. Overview of Pragmatic Randomized Clinical Trial Comparing Online vs In-Person Care in Patients With Psoriasis

Figure 3.. Changes in Psoriasis Disease Severity and Summary Data on Equivalency Evaluation

A, Change in psoriasis disease severity as measured by Psoriasis Area and Severity Index (PASI) score by group over 12 months. B, Change in psoriasis disease severity as measured by body surface area by group over 12 months. C, Change in psoriasis disease severity as measured by Patient Global Assessment (PtGA) score by group over 12 months. D, Summary data on equivalency evaluation. Error bars indicate 95% CI.