A multi-center, pragmatic, effectiveness-implementation (hybrid I) cluster randomized controlled trial to evaluate a child-oriented goal-setting approach in paediatric rehabilitation (the ENGAGE approach): a study protocol

Lesley Pritchard-Wiart, Sandy Thompson-Hodgetts, Ashley B McKillop, Rhonda Rosychuk, Kelly Mrklas, Lonnie Zwaigenbaum, Jennifer Zwicker, John Andersen, Gillian King, Pegah Firouzeh, Lesley Pritchard-Wiart, Sandy Thompson-Hodgetts, Ashley B McKillop, Rhonda Rosychuk, Kelly Mrklas, Lonnie Zwaigenbaum, Jennifer Zwicker, John Andersen, Gillian King, Pegah Firouzeh

Abstract

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).

Keywords: Goal-setting; Implementation evaluation; Pediatrics; Pragmatic trial; Rehabilitation.

Conflict of interest statement

Authors have no competing interests to declare.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study conceptual model (moderators indicated with thin arrows)
Fig. 2
Fig. 2
CONSORT 2010 flow diagram
Fig. 3
Fig. 3
Guiding principles of ENGAGE
Fig. 4
Fig. 4
SPIRIT flow chart for study enrolment, interventions and assessments
Fig. 5
Fig. 5
Data collection phases for the implementation evaluation

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