Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Kaelin V

PROVIDER: S-EPMC8728410 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundFamily-centered care is a valued approach to improving child and family outcomes in early intervention (EI), yet there is need to implement interventions that support information exchange for shared decision-making when planning and monitoring EI care. This study aims at estimating the feasibility, acceptability, and value of implementing the Young Children's Participation and Environment Measure (YC-PEM), a valid electronic patient-reported outcome (e-PRO) that is designed to support family engagement when planning care and monitoring outcomes of care.MethodsData were gathered from caregivers (N = 139) that were enrolled in a Phase 1 trial of the YC-PEM e-PRO as implemented within 1 month of their child's next EI evaluation of progress. YC-PEM e-PRO feasibility was estimated according to enrollment and completion rates, and mean completion time. Chi-square tests were used to examine parent perceptions of YC-PEM e-PRO acceptability by caregiver education and family income. Caregiver feedback via open-ended responses were content coded to inform intervention and protocol optimizations. YC-PEM e-PRO value was estimated via composite and item-level scores to capture the extent of participation difficulty in home and community activities, and common areas of need regarding caregivers desired change in their child's participation.ResultsFeasibility of implementing the YC-PEM e-PRO in routine EI care was mixed, as evidenced by low enrollment rates (21.0-29.2%), a high completion rate (85.3%), and limited missing data (80.6% of completed cases contained no missing data). More than half of the participants reported that the completion of the YC-PEM e-PRO was at least somewhat helpful, regardless of family income or caregiver education, providing support for its acceptability. As for its value, the YC-PEM e-PRO results were viewed by 64% of caregivers, whose desire for change most often pertained to the child's participation in non-discretionary activities at home and structured activities in the community.ConclusionsResults may support the implementation of YC-PEM e-PRO as a feasible, acceptable, and valued option for engaging families in planning the child's EI care. Results also inform select intervention and protocol optimizations prior to undertaking a multi-site pragmatic trial of its effectiveness on family engagement and shared decision-making within an EI clinical workflow.Trial registrationTrial number: NCT03904797 . Trial registered at Clinicaltrials.gov . Registered 22 March 2019. Retrospectively registered.

Project description:AimTo evaluate the feasibility, acceptability, and preliminary effects of Participation and Environment Measure-Plus (PEM+) 2.0, an optimized version of a web-based, participation-focused, care-planning tool.MethodTwenty-two caregivers of children aged 0 to 5 years receiving rehabilitation services, who reported dissatisfaction with their child's participation, had internet access, and could read and write English, were recruited for this 2-week, single-arm pilot trial. Feasibility was assessed through retention rates, completion time, percentage of care plans developed relative to caregiver reported need, and independent completion of PEM+ 2.0. Acceptability was assessed by the Usefulness, Satisfaction, and Ease of Use Questionnaire. Preliminary effects were assessed by two items on caregiver reported impact of PEM+ 2.0 on confidence for addressing their child's participation.ResultsEighteen caregivers completed at least one iteration of PEM+ 2.0; of those, 17 were female and 15 were 30 to 39 years old. The median completion time was 12.99 minutes (quartile 1, 6.30; quartile 3, 17.33), mean care plan creation relative to need was 50% (standard deviation [SD] 31), and 17 completed PEM+ 2.0 independently. Mean acceptability scores were 3.80 to 4.97 (SD 1.25-1.97) and mean preliminary effect scores were 4.61 to 4.72 (SD 1.85-2.24), out of 7.0. There were strong and significant positive associations between two of the three estimates of PEM+ 2.0 acceptability and caregiver confidence (r=0.577-0.793, p<0.01).InterpretationElectronic health tools have the potential for facilitating family-centered care in pediatric rehabilitation. PEM+ 2.0 is a feasible tool within pediatric rehabilitation and has potential to be an acceptable tool for improving caregiver confidence for promoting their child's participation in valued activities.What this paper addsParticipation and Environment Measure-Plus (PEM+) 2.0 is feasible for collaboratively engaging caregivers in the care-planning process. Caregivers perceived PEM+ 2.0 as helpful for thinking about their child's participation and what can be done to improve it. Feasibility and acceptability results will inform PEM+ 2.0 optimizations.

Project description:IntroductionUsing patient-reported outcome measures (PROMs) with children have been described as 'giving a voice to the child'. Few studies have examined the routine use of these measures as potentially therapeutic interventions. This study aims to investigate: (1) the effectiveness of feedback using graphical displays of information from electronic PROMs (ePROMs) that target health-related quality of life, to improve health outcomes, referrals and treatment satisfaction and (2) the implementation of ePROMs and graphical displays by assessing acceptability, sustainability, cost, fidelity and context of the intervention and study processes.Methods and analysisA hybrid II effectiveness-implementation study will be conducted from February 2020 with children with life-altering skin conditions attending two outpatient clinics at a specialist paediatric children's hospital. A pragmatic randomised controlled trial and mixed methods process evaluation will be completed. Randomisation will occur at the child participant level. Children or parent proxies completing baseline ePROMs will be randomised to: (1) completion of ePROMs plus graphical displays of ePROM results to treating clinicians in consultations, versus (2) completion of ePROMs without graphical display of ePROM results. The primary outcome of the effectiveness trial will be overall health-related quality of life of children. Secondary outcomes will include other health-related quality of life outcomes (eg, child psychosocial and physical health, parent psychosocial health), referrals and treatment satisfaction. Trial data will be primarily analysed using linear mixed-effects models; and implementation data using inductive thematic analysis of interviews, meeting minutes, observational field notes and study communication mapped to the Consolidated Framework for Implementation Research.Ethics and disseminationEthical approval was obtained from Children's Health Queensland Human Research Ethics Committee (HREC/2019/QCHQ/56290), The University of Queensland (2019002233) and Queensland University of Technology (1900000847). Dissemination will occur through stakeholder groups, scientific meetings and peer-reviewed publications.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12620000174987).

Project description:Objective The aim of the study is to identify and prioritize early intervention (EI) stakeholders' perspectives of supports and barriers to implementing the Young Children's Participation and Environment Measure (YC-PEM), an electronic patient-reported outcome (e-PRO) tool, for scaling its implementation across multiple local and state EI programs.Methods An explanatory sequential (quan > QUAL) mixed-methods study was conducted with EI families (n = 6), service coordinators (n = 9), and program leadership (n = 7). Semi-structured interviews and focus groups were used to share select quantitative pragmatic trial results (e.g., percentages for perceived helpfulness of implementation strategies) and elicit stakeholder perspectives to contextualize these results. Three study staff deductively coded transcripts to constructs in the Consolidated Framework for Implementation Research (CFIR). Data within CFIR constructs were inductively analyzed to generate themes that were rated by national early childhood advisors for their relevance to longer term implementation.Results All three stakeholder groups (i.e., families, service coordinators, program leadership) identified thematic supports and barriers across multiple constructs within each of four CFIR domains: (1) Six themes for "intervention characteristics," (2) Six themes for "process," (3) three themes for "inner setting," and (4) four themes for "outer setting." For example, all stakeholder groups described the value of the YC-PEM e-PRO in forging connections and eliciting meaningful information about family priorities for efficient service plan development ("intervention characteristics"). Stakeholders prioritized reaching families with diverse linguistic preferences and user navigation needs, further tailoring its interface with automated data capture and exchange processes ("process"); and fostering a positive implementation climate ("inner setting"). Service coordinators and program leadership further articulated the value of YC-PEM e-PRO results for improving EI access ("outer setting").Conclusion Results demonstrate the YC-PEM e-PRO is an evidence-based intervention that is viable for implementation. Optimizations to its interface are needed before undertaking hybrid type-2 and 3 multisite trials to test these implementation strategies across state and local EI programs with electronic data capture capabilities and diverse levels of organizational readiness and resources for implementation.