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A multi-center, pragmatic, effectiveness-implementation (hybrid I) cluster randomized controlled trial to evaluate a
Lesley Pritchard-Wiart1, Sandy Thompson-Hodgetts2, Ashley B McKillop3
1Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta, University of Alberta, 3-60 Corbett Hall, Edmonton, AB, T6G 2G4, Canada. lwiart@ualberta.ca.
Insights
Child-focused goal-setting in pediatric rehabilitation, Enhancing Child Engagement in Goal-Setting (ENGAGE), may improve therapy outcomes. This trial compares ENGAGE to usual care, assessing effectiveness, cost, and implementation factors.
Area of Science:
- Pediatric Rehabilitation
- Implementation Science
- Clinical Trial Design
Background:
- Child-oriented goal-setting in pediatric rehabilitation can enhance motivation, engagement, and outcomes.
- The Enhancing Child Engagement in Goal-Setting (ENGAGE) approach aims to improve these aspects compared to usual practice.
- Understanding implementation barriers and facilitators is crucial for widespread adoption.
Purpose of the Study:
- To determine the effectiveness of the ENGAGE child-focused goal-setting approach in pediatric rehabilitation.
- To compare the costs and secondary outcomes of ENGAGE versus usual care.
- To explore factors influencing child engagement and rehabilitation outcomes, and implementation challenges.
Main Methods:
- A pragmatic, multi-site, cluster randomized controlled trial with an effectiveness-implementation hybrid type 1 design.
- Therapists randomized to ENGAGE or usual care, recruiting children aged 5-12 with neurodevelopmental conditions.
- Outcomes measured include goal performance, therapy engagement, functional abilities, quality of life, and implementation barriers/facilitators via qualitative interviews.
Main Results:
- Primary outcome: goal performance.
- Secondary outcomes: engagement in therapy, functional abilities, participation, quality of life, cost-effectiveness.
- Qualitative data will identify implementation barriers and facilitators.
Conclusions:
- This study will evaluate the impact of collaborative, child-focused goal-setting in pediatric rehabilitation.
- Findings will inform the effective implementation of the ENGAGE approach.
- The research aims to optimize pediatric rehabilitation services through enhanced child engagement.
Background:
Child-oriented goal-setting in pediatric rehabilitation may improve child motivation, engagement in therapy, child outcomes related to therapy, and service delivery efficiency. The primary objective of this trial is to determine the effectiveness of a principles-driven, child-focused approach to goal-setting, Enhancing Child Engagement in Goal-Setting (ENGAGE), on pediatric rehabilitation outcomes compared to usual practice. The three secondary objectives are to 1) compare costs and secondary outcomes of the ENGAGE approach to usual practice, 2) determine the influence of child, parent and therapist characteristics on child engagement in therapy and rehabilitation outcomes, and 3) identify barriers and facilitators to the implementation of ENGAGE.
Methods:
This research protocol describes a pragmatic, multi-site, cluster, effectiveness-implementation (hybrid type 1 design) randomized controlled trial. Therapists (n = 12 clusters of two therapists) at participating sites (n = 6) will be randomized to 1) the ENGAGE intervention group, or 2) usual care (control) using a computer-generated, permuted-block randomization sequence with site as a stratification variable designed by a statistician (RR). Each therapist will recruit four children 5-12 years old with neurodevelopmental conditions (n = 96), who will receive ENGAGE or usual care, according to therapist group allocation. ENGAGE therapists will be trained to use a 'toolbox' of evidence-driven, theory-informed principles to optimize child and parent motivation, engagement in the goal-setting process, and performance feedback strategies. Outcomes include goal performance (primary outcome), engagement in therapy, functional abilities, participation, and parent and child quality of life. Qualitative interviews with children, parents, ENGAGE therapists, and managers will explore challenges to implementation and potential mitigation strategies. Mixed effects multiple linear regression models will be developed for each outcome to assess group differences adjusted for clustering. A cost-effectiveness analysis will combine cost and a measure of effectiveness into an incremental cost-effectiveness ratio. Qualitative data on implementation will be analyzed inductively (thematic analysis) and deductively using established implementation science frameworks.
Discussion:
This study will evaluate the effects of collaborative goal-setting in pediatric rehabilitation and inform effective implementation of child-focused goal-setting practices.
Trial Registration:
NCT05017363 (registered August 23, 2021 on ClinicalTrials.gov).
