Feasibility of a randomized controlled trial of paediatric interdisciplinary pain management using home-based telehealth

Abstract

Purpose: Chronic pain is common in adolescents. Evidence-based guidelines recommend interdisciplinary treatment, but access is limited by geography. The development of hybrid programs utilizing both face-to-face and videoconference treatment may help overcome this. We developed a 7-week hybrid pediatric interdisciplinary pain program (Hybrid-PIPP) and wished to compare it to individual face-to-face sessions (Standard Care). Our objective was to test the feasibility of a protocol that used a matched pair un-blinded randomized controlled design to investigate the efficacy and cost-effectiveness of the Hybrid-PIPP compared to Standard Care. Patients and Methods: Parent–adolescent dyads were recruited from tertiary pediatric clinics and matched by disability before randomization to minimize allocation bias. The adolescents (aged 11–17) had experienced primary pain for >3 months. Hybrid-PIPP involved 11 hrs of group therapy and 4 individual videoconference sessions. Standard care was provided by the same clinical team, using the same treatment model and similar intensity as the Hybrid-PIPP. The intention was to recruit participants for 3 Hybrid-PIPP groups with a comparison stream. Recruitment was ceased after 2 groups due to the high participant disability requiring more intensive intervention. Results: Eighteen dyads were screened and 13 randomized (7 Hybrid-PIPP, 6 Standard Care, 2 unsuitable, 3 unallocated when the study was stopped). The study met a priori feasibility criteria for staff availability; recruitment rate; treatment completion; and data collection. Global satisfaction ratings were similar in both streams (SC median 7, range 5–9 and Hybrid-PIPP median 8.5, range 5–10). Challenges were identified in both streams. A future modified Hybrid-PIPP was considered acceptable if the intensity is increased to manage the high level of disability. Standard care was considered inefficient. No adverse events were reported. Conclusion: The study determined that the protocol met a priori feasibility criteria, but to be practicable in a real world, health environment requires significant modifications. Registration: ANZTR(ACTRN2614000489695).