Efficiency and Scalability of Electronic Patient-Reported Outcome Measurement and Decision Support Tool for Family-Centered and Participatory Early Intervention: PROSPECT Type 1 Hybrid Trial Protocol

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BMJ Open. Jan 4, 2022; 12 (1): e051582. doi: 10.1136 / bmjopen-2021-051582.

ABSTRACT

INTRODUCTION: Early Intervention (EI) endorses family-centered and participatory services, but options remain insufficient to consistently adopt this service approach. The Electronic Patient-Reported Outcome Measure for Early Childhood Engagement and Environment (YC-PEM e-PRO) is an evidence-based measurement for caregivers that enables EI services focused on family. Parent Reported Findings for Strengthening Partnership Within the Early Intervention Care Team (PROSPECT) is a community-based pragmatic trial examining the effectiveness of the measure and tool implementation. YC-PEM e-PRO decision aid as an option to be used in routine EI care. , on the quality of services and the results for children (objective 1). Once the trial is complete, we will characterize the perspectives of the facilitator stakeholders and the obstacles to its implementation in several CI programs (objective 2).

METHODS AND ANALYSIS: This study uses a hybrid type 1 efficacy-delivery study model. For objective 1, we aim to enroll 223 caregivers of children with or at risk of developmental disabilities or delays. developmental children aged 0 to 3 who have accessed EI services for three months or more under an EI program in the Denver Metro Watershed, Colorado. Participants will be invited to register for 12 months, starting from the annual assessment of their child’s progress. Participants will be randomized using a cluster randomized design at the CI service coordinator level. Both groups will complete the baseline testing and follow-up assessment at 1, 6, and 12 months. A generalized linear mixed model will be fitted for each outcome of interest, with group, time and their interactions as primary fixed effects, and an adjustment for child age and severity of condition as secondary fixed effects. . For objective 2, we will organize focus groups with EI stakeholders (families of the intervention group, service coordinators and other service providers of the EI program, and program management) which will be analyzed. thematically to explain the results of objective 1 and identify remaining supports and obstacles. to its wider implementation in several CI programs.

ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Boards of the University of Illinois at Chicago (2020-0555) and the University of Colorado (20-2380). An active dissemination plan will ensure that the results have maximum reach for research and practice.

TEST REGISTRATION NUMBER: NCT04562038.

PMID:34983760 | DO I:10.1136 / bmjopen-2021-051582


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Sara H. Byrd