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Published on: April 14, 2016
Protocol for a multi-phase, multi-center, real-world, hybrid effectiveness-implementation study of a digital
Rocío de la Vega1,2, Elena R Serrano-Ibáñez1,2, Gema T Ruiz-Párraga1,2
1Facultad de Psicología y Logopedia, Universidad de Málaga, Málaga, Spain.
Insights
This study co-develops a digital pain management tool for adolescents with chronic pain, aiming to improve adherence and provide a sustainable implementation plan for better care access.
Area of Science:
- Digital health interventions
- Pediatric chronic pain management
- Implementation science
Background:
- Adolescents with chronic pain are a vulnerable group needing accessible management resources.
- Early intervention is crucial to mitigate long-term personal, social, and economic consequences.
- Existing digital health interventions face challenges with suboptimal adherence and sustainable implementation.
Purpose of the Study:
- To co-develop a digital intervention for pediatric chronic pain (Digital SPA) with end-users.
- To evaluate the effectiveness and implementation outcomes of the Digital SPA in Spain.
- To address gaps in adherence and sustainable delivery of digital health solutions for chronic pain.
Main Methods:
- Phase 1: Focus groups with patients, parents, and clinicians to identify unmet needs and inform co-design.
- Phase 2: Theory-driven content creation and usability testing based on Phase 1 findings and evidence.
- Phase 3: Hybrid effectiveness-implementation trial with 195 adolescents (12-17 years) and parents, assessing function, pain, sleep, anxiety, mood, and healthcare utilization.
Main Results:
- The study is expected to yield a co-created, evidence-based digital intervention for pediatric chronic pain.
- A roadmap for successful implementation of the intervention will be produced.
- The study will provide insights into improving adherence and sustainable implementation of digital health tools.
Conclusions:
- Co-designing digital interventions with end-users can enhance treatment adherence.
- Documenting the implementation process facilitates replication and adaptation in diverse settings.
- This research will advance knowledge on implementing digital health solutions for adolescents with chronic pain, particularly those lacking in-person multidisciplinary care.
Background:
Children and adolescents with chronic pain are a vulnerable population who often lack the resources to manage their condition. Due to high personal, social, and economic consequences, proper management in its early stages is key to reducing disability. The aim of this project is to co-develop a digital intervention for pediatric chronic pain (Digital SPA) with end-users and to evaluate its effectiveness and implementation outcomes in Spain.
Methods:
(Phase 1) Focus groups with patients, parents, and clinicians (n = 5-6 each) will inform about unmet pain care needs and provide a starting point for co-designing the intervention. (Phase 2) Content creation and usability testing will be based on the results of Phase 1, and the theory-driven development will follow the latest available evidence. The intervention will use validated psychological techniques focused on improving functioning by teaching pain coping skills. (Phase 3) Hybrid effectiveness-implementation trial. Participants (n = 195) will be adolescents aged 12-17 years old with chronic pain and one of their parents. Assessments include physical function, pain, sleep, anxiety, mood, satisfaction and adherence to the treatment, and number of visits to the emergency room. A qualitative framework analysis will be conducted with data from Phase 1. Effects of the intervention will be evaluated using linear multilevel modeling. The Consolidated Framework for Implementation Research (CFIR) and Behavioral Interventions Using Technology (BIT) frameworks will be used to evaluate implementation.
Discussion:
This study is expected to produce a co-created evidence-based digital intervention for pediatric chronic pain and a roadmap for successful implementation.
Trial Registration Number Trn And Date Of Registration:
ClinicalTrials.gov (registered on 26 June 2023: https://clinicaltrials.gov/study/NCT05917626). Contributions to the literature The implementation of digital health interventions has two major gaps: (1) adherence to treatment is suboptimal, and (2) the process of making the interventions available to the end-user in a sustainable way is often unsuccessful.In this study, we expect that assessing users' needs and co-designing an intervention with them will improve adherence.Documenting the implementation process from the project inception and integrating the results into an implementation framework will allow for replication and extension in different contexts.This study will increase the knowledge about implementation in a vulnerable population: adolescents with chronic pain without access to in-person multidisciplinary pain care.
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