Comparing Online Care with In-Person Care for Patients with Psoriasis [Internet]

Excerpt

Background: Psoriasis is a chronic, inflammatory skin disease that affects 3% to 4% of the US population and is associated with several serious comorbidities. Many patients with psoriasis lack regular specialty care and experience worse clinical outcomes and reduced quality of life than those who do not have psoriasis.

Objectives: To determine whether an online, collaborative, connected health model results in equivalent improvements in disease severity, quality of life, and mental health, and whether the online model provides better access to specialty care compared with usual in-person care for psoriasis management.

Design: The PCORI Psoriasis Teledermatology Trial was a 12-month, pragmatic randomized controlled equivalency trial to evaluate the impact of an online model for psoriasis compared with regular in-person care. The study took place between 2014 and 2017.

Population and setting: Participants were adults with psoriasis from ambulatory dermatology and primary care clinics in northern California, southern California, and Colorado. Eligibility criteria were being aged ≥ 18 years; having physician-diagnosed psoriasis; and having access to the internet, a camera, and primary care providers.

Interventions: Participants were randomly assigned 1:1 to online or 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. For the in-person group, their appointments took place with providers face to face in dermatology or primary care clinics. The frequency of online or in-person visits was determined by medical necessity. All participants were exposed to their respective interventions for 12 months.

Outcomes: All outcomes were prespecified. We measured psoriasis disease severity endpoints by Self-Administered Psoriasis Area and Severity Index (SA-PASI), body surface area (BSA), and patient global assessment (PtGA). The SA-PASI is a validated scale with possible scores ranging from 0 to 72. The primary endpoint was the difference in improved SA-PASI scores between the online and in-person groups over 12 months. Secondary psoriasis disease severity endpoints included BSA and PtGA; other secondary endpoints included quality of life, mental health, and access-to-care measures.

Data sources: We collected data using online surveys administered at baseline and 3-month intervals until study completion. We conducted qualitative interviews at month 6 and month 12.

Methods of analysis and evaluation: In this equivalency trial, we used an intention-to-treat approach to analyze all clinical and quality-of-life outcomes. Equivalence margins for all outcome measures were determined a priori and were derived from clinical trials evaluating systemic medications for psoriasis. All equivalence margins were considered clinically meaningful by clinicians and psoriasis patients during pilot work. Equivalence margins for SA-PASI, BSA, and PtGA were ±6.5, ±6.5%, and ±0.25, respectively. We used mixed models for repeated measures as the primary analysis for handling missing data. This approach included all available data to estimate study group-specific means at 3, 6, 9, and 12 months for disease severity and quality-of-life outcomes.

Results: The 300 enrolled participants were 50% female and 63% white, with a mean age of 49 years (SD ± 14). The completion rates for the quarterly assessments were 93% at month 3, 90% at month 6, 89% at month 9, and 86% at month 12. In the online group, the mean change in SA-PASI from baseline across follow-up visits was −1.37 (SD ± 3.33). In the in-person group, the mean change from baseline across follow-up visits was −0.82 (SD ± 3.43). The adjusted difference in the mean change in SA-PASI over 12 months between the online and in-person groups was −0.27 (95% CI, −0.85 to 0.31).

In the online group, the mean change in BSA from baseline across follow-up visits was −3.38% (SD ± 11.08%). In the in-person group, the mean change from baseline across follow-up visits was −1.55% (SD ± 8.87%). The difference in the mean change in BSA between the 2 groups was −0.05% (95% CI, −1.58% to 1.48%). The confidence intervals for the between-group differences in SA-PASI and BSA were within the prespecified equivalence margins (±6.5 and ±6.5%, respectively), which demonstrated equivalence between the 2 interventions. In the online group, the mean change in PtGA from baseline across follow-up visits was −0.37 (SD ± 1.00). In the in-person group, the mean change from baseline across follow-up visits was −0.22 (SD ± 1.26). The difference in the mean change in PtGA between the 2 groups was −0.11 (95% CI, −0.32-0.10); the lower bound for the 95% CI is outside the lower bound of the prespecified equivalence margin (−0.25), indicating an inconclusive result for equivalence for the PtGA outcome.

In the online group, the mean change in health-related quality of life from baseline across follow-up visits was −9.02 (SD ± 20.67). In the in-person group, the mean change from baseline across follow-up visits was −10.55 (SD ± 23.50). The adjusted difference in the mean change in Skindex-16 over 12 months between the online and in-person groups was −0.83 (95% CI, −5.18 to 3.51).

In the online group, the mean change in Dermatology Life Quality Index (DLQI) from baseline across follow-up visits was −1.64 (SD ± 4.34). In the in-person group, the mean change from baseline across follow-up visits was −1.18 (SD ± 4.77). The difference in the mean change in DLQI between the 2 groups was −0.45 (95% CI, −1.29 to 0.38). In the online group, the mean change in Patient Health Questionnaire-9 (PHQ-9) from baseline across follow-up visits was − 0.4 (SD ± 3.94). In the in-person group, the mean change from baseline across follow-up visits was −0.76 (SD ± 4.66). The difference in the mean change in PHQ-9 between the 2 groups was − 0.33 (95% CI, −1.20 to 0.55). Between-group differences in Skindex-16, DLQI, and PHQ-9 were within prespecified equivalence margins (± 7.0, ± 2.5, and ± 3.0, respectively), which demonstrated equivalence between the 2 assignments.

Over 12 months the patients in the in-person group traveled an average of 108.6 (SD ± 358.8) miles to get to and from their appointments, compared with 1.4 (SD ± 8.8) miles for the online group (p = 0.0003). The patients in the in-person group spent an average of 4.0 (SD ± 4.5) hours on in-person visits (round-trip travel plus in-office wait time) over 12 months, compared with 0.1 (SD ±0.4) hours for the online group (p = 0.0001). Patients found the online model to be safe, accessible, efficient, effective, and patient-centered. Primary care physicians expressed that the online model was convenient for accessing dermatologists, and dermatologists deemed the model to be highly effective for providing care to patients with chronic skin diseases.

Conclusions: The collaborative online model was as effective as in-person care in improving clinical, quality-of-life, and mental health outcomes for patients with psoriasis. The online model resulted in superior access to specialty care compared with in-person management. Innovative telehealth delivery models that emphasize collaboration, quality, and efficiency can be transformative in improving patient-centered outcomes for individuals with chronic diseases.

Limitations: Due to the nature of the random assignments, study participants were not able to be blinded to the intervention.