A Digital Health Psychological Intervention (WebMAP Mobile) for Children and Adolescents With Chronic Pain

Results of a Hybrid Effectiveness-implementation Stepped-wedge Cluster Randomized Trial

Tonya M. Palermo; Rocio de la Vega; Caitlin Murray; Emily Law; Chuan Zhou

Disclosures

Pain. 2020;161(12):2763-2774. 

In This Article

Abstract and Introduction

Abstract

Although psychological treatments benefit youth with chronic pain, treatment is not accessible in most communities. Digital health interventions offer promise for expanding access and reach to this population. Using a stepped-wedge cluster randomized trial design, we evaluated effectiveness and implementation of a digital health delivered psychological intervention for pediatric chronic pain. One hundred forty-three youth, aged 10 to 17 years, with chronic pain and a caregiver were recruited from 8 clinics in the United States. Active intervention included access to the Web-based Management of Adolescent Pain (WebMAP) Mobile app and the WebMAP parent web site to learn pain self-management skills. Effectiveness outcomes included pain intensity, disability, and patient global impression of change, while Reach, Adoption, Implementation, and Maintenance were implementation outcomes. Results showed that youth in both treatment conditions (WebMAP vs Usual Care) had similar changes over time in pain and disability. Youth in the WebMAP condition perceived greater improvement (patient global impression of change) at post-treatment and follow-up (d's = 0.54 and 0.44, P < 0.05) compared with youth receiving usual care. Use of the digital health intervention was modest and variable; approximately 30% of youth and parents completed treatment. Greater engagement (number of completed modules) was associated with significantly greater reductions in pain and disability from pre-treatment to follow-up (d's = −0.57 and −0.38, P < 0.05). Parents, youth, and providers found treatment acceptable; providers had positive attitudes and demonstrated referrals over a maintenance period. Further research is needed to understand how to enhance treatment engagement with digital health interventions and optimize implementation.

Introduction

In the United States alone, 2 to 5 million children experience chronic pain[21,26] and are at risk of impairments in physical and psychosocial functioning. A robust evidence base demonstrates that psychological treatments have small to moderate effects for reducing pain and disability in children with chronic pain.[15] Because children with chronic pain are at risk of continued pain,[23,41] worse educational, vocational, and social outcomes in adulthood,[31] effective intervention during childhood is a key priority to address the overall societal burden of chronic pain. Despite the promise of psychological interventions for chronic pain management, few children have access to them[39] because of numerous barriers including geographic distance[4,7] and long wait-lists.[35]

Digital health interventions targeting behavior change (ie, psychological interventions delivered through the Internet and smartphone applications) have the unique potential to bridge this critical gap in service delivery. According to a recent Pew Research Center Internet Survey, 95% of teens in the United States own a smartphone and use the Internet daily.[37] Digital health interventions for pediatric chronic pain are emerging.[13] Our own Internet-delivered program, Web-based Management of Adolescent Pain (WebMAP),[33] has shown excellent patient engagement and small to moderate treatment effects for improving pain-related outcomes in a large-scale randomized controlled trial (RCT).[33]

Although positioned to overcome major barriers to access, effectiveness of digital health interventions for pediatric chronic pain in real-world settings—outside the tightly controlled setting of a randomized clinical trial design—has not been widely studied.[15] Furthermore, factors that may hinder or facilitate real-world implementation of digital health interventions in this population are understudied.[3,30] Systematic reviews have shown that end users do not typically have access to tools developed during research studies; for example, only 13 of 53 tools were found to be publicly available in a review of eHealth tools for pediatric pain management,[19] reducing their real-world impact. Hybrid effectiveness-implementation clinical trials have the potential to address these gaps.[28] To the best of our knowledge, there have not been any previous clinical trials of psychological interventions for youth with chronic pain that have evaluated both treatment effectiveness and implementation in real-world clinical settings.

Building on our previous work with WebMAP,[32,33] the goals of this hybrid effectiveness-implementation clinical trial are to (1) evaluate the real-world usage and effectiveness of WebMAP for youth with chronic pain and (2) assess implementation of WebMAP in pediatric specialty care and pain clinic settings across the United States. Using a stepped-wedge cluster randomized trial (SW-CRT) design, we hypothesized that youth receiving the WebMAP program would show greater improvements in pain-related disability, pain intensity, and patient-reported global impression of change compared with youth receiving usual care. We hypothesized that youth and parents would use the intervention in real-world clinical settings, and that higher engagement in the WebMAP program would be associated with greater treatment benefit. Finally, we expected to find that WebMAP would have adequate reach, adoption, implementation, and maintenance (assessed by the Reach, Effectiveness, Adoption, Implementation, and Maintenance [RE-AIM] framework).

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