A Randomized Feasibility Study of Virtual and Face-to-Face Care Using a Novel Mobile Health Solution for Outpatient...

Burn injury in childhood is common, and patients often travel long distances to burn centers due to regionalization of care. To address these geographic disparities, we created a smartphone app, telemedicine optimized burn intervention (TOBI), to provide access to burn care in the outpatient setting. We conducted a randomized controlled trial to assess the feasibility, acceptability, trial methodology, and variability estimates for a larger efficacy study. Eligible pediatric burn patients were recruited in the emergency or clinic setting and randomly assigned to virtual outpatient care with TOBI or routine face-to-face (FTF) care in the clinic. Participation, study retention, compliance with prescribed burn care regimen, and clinical outcomes were assessed at baseline and each visit. After approaching 85 families, 65 (78%) patient/caregiver dyads were randomized to TOBI (n = 32) or FTF care (n = 33). The average age was 7.8 (5.4) vs 5.5 (4.6) years with 2.4 (2.1) vs 2.2 (1.6) % TBSA partial thickness burns in the TOBI and FTF groups, respectively. Treatment adherence was similar (TOBI 85% vs FTF 77%, 95% CI [-9.4, 25.7]), as were burn care completion rates (TOBI 91% vs FTF 76%, 95% CI [-0.03, 0.3]). Telemedicine optimized burn intervention patients had less pain (0.3 vs 1.0, 95% CI [-1.3, -0.1]), fewer in-person clinic visits (1.1 vs 2.1, 95% CI [-1.2, -0.7]), and shorter travel time (2.3 vs 4.0 h, 95% CI [-3.5, -0.1]). Virtual outpatient care was well-received by pediatric burn patients and caregivers, with strong engagement. The study established clinical efficacy endpoints for a future large-scale study. Clinical Trial Registration ID: 005019144.