A Randomized Controlled Trial of a Web-Based Management Support System for Children With Urinary Incontinence: The eADVICE Trial

Abstract

Purpose:Children referred to specialist outpatient clinics by primary care providers often have long waiting times before being seen. We assessed whether an individualized, web-based, evidence-informed management support for children with urinary incontinence while waiting reduced requests for specialist appointments.Materials and Methods:A multicenter, waitlisted randomized controlled trial was conducted for children (5-18 years) with urinary incontinence referred to tertiary pediatric continence clinics. Participants were randomized to the web-based eHealth program electronic Advice and Diagnosis Via the Internet following Computerized Evaluation (eADVICE), which used an embodied conversational agent to engage with the child at the time of referral (intervention) or 6 months later (control). The primary outcome was the proportion of participants requesting a clinic appointment at 6 months. Secondary outcomes included persistent incontinence, and the Paediatric incontinence Questionnaire (PinQ) score.Results:From 2018 to 2020, 239 children enrolled, with 120 randomized to eADVICE and 119 to the control arm. At baseline, participants’ mean age was 8.8 years (SD 2.2), 62% were males, mean PinQ score was 5.3 (SD 2.2), 36% had daytime incontinence, and 97% had nocturnal enuresis. At 6 months, 78% of eADVICE participants vs 84% of controls requested a clinic visit (relative risk 0.92, 95% CI 0.79, 1.06, P = .3), and 23% eADVICE participants vs 10% controls were completely dry (relative risk 2.23, 95% CI 1.10, 4.50, P = .03). The adjusted mean PinQ score was 3.5 for eADVICE and 3.9 for controls (MD −0.37, 95% CI −0.71, −0.03, P = .03).Conclusions:The eADVICE eHealth program for children awaiting specialist appointments doubled the proportion who were dry at 6 months and improved quality of life but did not reduce clinic appointment requests.

An Economic Evaluation of a Web-Based Management Support System for Children With Urinary Incontinence: The eADVICE Trial

“…Methods for multiple imputation are detailed in the clinical effectiveness paper. 10 Briefly, missing data were imputed 34 times, given 34% missing data using Fully Conditional Specification with the mice package version 3.14.0 22 for R with effectiveness and cost regression coefficients pooled using Rubin's rules. For economic analysis, bootstrapping with multiple imputation was performed with the bootImpute package version 1.2.0 for R using the von Hippel and Barlett approach.…”

“…8,9 Clinical effectiveness results of the eADVICE multicenter, waitlist-controlled, randomized trial have now been published. 10 The use of eADVICE during the waiting period doubled the proportion of children who were dry at 6 months (from 10%-23%) and improved quality of life (QoL) but did not reduce clinic appointment requests. 10 The finding of no commensurate reduction in requests for specialist appointments given improved clinical outcomes raised questions as to the cost-effectiveness of the program, making this economic evaluation substudy of the eADVICE trial even more critical to complete.…”

“…The detailed design of the eADVICE trial has been reported in the study protocol (Supplementary Appendix 2, https://www.jurology.com) and clinical effectiveness paper. 10 Briefly, the trial was a multicenter waitlist-controlled randomized trial of eADVICE vs usual care for patients aged 5 to 18 years with daytime incontinence (at least twice per week) or enuresis (at least three times per week), referred to three metropolitan specialist continence clinics in NSW, Australia. One child per family could participate.…”

“…The development and operation of eADVICE have previously been reported in detail. 7,10 Briefly, eADVICE is a web-based program with an embodied conversational agent named Dr Evie (eADVICE Virtual agent for Incontinence and Enuresis) with which the child and family can interact while waiting for a specialist appointment. Individualized treatment advice, assessment, and diagnosis are facilitated using the child's data to determine the best treatment protocol.…”