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Effectiveness and scalability of an electronic patient-reported outcome measure and decision support tool for family-centred and participation-focused early intervention: PROSPECT hybrid type 1 trial protocol
Children's Participation in Environment Research Lab, University of Illinois at Chicago, Chicago, Illinois, USA; Rehabilitation Sciences, University of Illinois at Chicago, Chicago, Illinois, USA.ORCID iD: 0000-0003-1290-9441
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2022 (English)In: BMJ Open, E-ISSN 2044-6055, Vol. 12, no 1, article id e051582Article in journal (Refereed) Published
Abstract [en]

Introduction: Early intervention (EI) endorses family-centred and participation-focused services, but there remain insufficient options for systematically enacting this service approach. The Young Children’s Participation and Environment Measure electronic patient-reported outcome (YC-PEM e-PRO) is an evidence-based measure for caregivers that enables family-centred services in EI. The Parent-Reported Outcomes for Strengthening Partnership within the Early Intervention Care Team (PROSPECT) is a community-based pragmatic trial examining the effectiveness of implementing the YC-PEM e-PRO measure and decision support tool as an option for use within routine EI care, on service quality and child outcomes (aim 1). Following trial completion, we will characterise stakeholder perspectives of facilitators and barriers to its implementation across multiple EI programmes (aim 2).

Methods and analysis: This study employs a hybrid type 1 effectiveness-implementation study design. For aim 1, we aim to enrol 223 caregivers of children with or at risk for developmental disabilities or delays aged 0–3 years old that have accessed EI services for three or more months from one EI programme in the Denver Metro catchment of Colorado. Participants will be invited to enrol for 12 months, beginning at the time of their child’s annual evaluation of progress. Participants will be randomised using a cluster-randomised design at the EI service coordinator level. Both groups will complete baseline testing and follow-up assessment at 1, 6 and 12 months. A generalised linear mixed model will be fitted for each outcome of interest, with group, time and their interactions as primary fixed effects, and adjusting for child age and condition severity as secondary fixed effects. For aim 2, we will conduct focus groups with EI stakeholders (families in the intervention group, service coordinators and other service providers in the EI programme, and programme leadership) which will be analysed thematically to explain aim 1 results and identify supports and remaining barriers to its broader implementation in multiple EI programmes.

Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2022. Vol. 12, no 1, article id e051582
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Occupational Therapy
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URN: urn:nbn:se:umu:diva-212593DOI: 10.1136/bmjopen-2021-051582ISI: 000739490700007PubMedID: 34983760Scopus ID: 2-s2.0-85122755036OAI: oai:DiVA.org:umu-212593DiVA, id: diva2:1785909
Available from: 2023-08-07 Created: 2023-08-07 Last updated: 2023-08-28Bibliographically approved

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Kaelin, Vera C.

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