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.

Autor:	Kaelin V; 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., Villegas V; Children's Participation in Environment Research Lab, University of Illinois at Chicago, Chicago, Illinois, USA., Chen YF; Center for Clinical and Translational Science, University of Illinois at Chicago, Chicago, Illinois, USA., Murphy N; Health Systems, Management & Policy, University of Colorado - Anschutz Medical Campus, Aurora, Colorado, USA., Papautsky E; Biomedical & Health Information Sciences, University of Illinois at Chicago, Chicago, Illinois, USA., Litfin J; Rocky Mountain Human Services, Denver, Colorado, USA., Leland N; Occupational Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA., Maheshwari V; Children's Participation in Environment Research Lab, University of Illinois at Chicago, Chicago, Illinois, USA., McManus B; Health Systems, Management & Policy, University of Colorado - Anschutz Medical Campus, Aurora, Colorado, USA., Khetani M; Children's Participation in Environment Research Lab, University of Illinois at Chicago, Chicago, Illinois, USA mkhetani@uic.edu.; Rehabilitation Sciences, University of Illinois at Chicago, Chicago, Illinois, USA.; CanChild Centre for Childhood Disability Research, McMaster University, Hamilton, Ontario, Canada.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2022 Jan 04; Vol. 12 (1), pp. e051582. Date of Electronic Publication: 2022 Jan 04.
DOI:	10.1136/bmjopen-2021-051582
Abstrakt:	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. Ethics and Dissemination: This study has been approved by the institutional review boards at the University of Illinois at Chicago (2020-0555) and University of Colorado (20-2380). An active dissemination plan will ensure that findings have maximum reach for research and practice. Trial Registration Number: NCT04562038. Competing Interests: Competing interests: The YC-PEM e-PRO is licensed for distribution through CanChild Centre for Childhood Disability Research. MK shares in revenue from YC-PEM sales for research and development activities in the Children’s Participation in Environment Research Lab (CPERL) at the University of Illinois at Chicago. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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