Implementation of Electronic Shared Decision-Making Support for Early Intervention
Condition: Child Development Disorder; Development Delay
MeSH terms: Developmental Disabilities
Study type: Interventional

Summary: 
      Family-centered care is a best practice approach to delivering high quality early
      intervention (EI) services for children 0-3 years old with developmental needs. Yet, family
      engagement in designing and monitoring their child's EI service plan is suboptimal. Families
      need a valid, reliable, and useful tool to share in decisions about the scope of their
      child's EI service plan. The investigators will achieve a major advance in contributing
      occupational therapy expertise to improve family engagement when designing and monitoring
      their child's EI services. The investigators will test the use of an evidence-based
      electronic tool with families at one EI program, when the child is due for an annual review
      of progress in the program. The investigators will also gather input from families,
      practitioners, and program leadership to identify facilitators and barriers to its use in
      multiple EI programs. This project tries to test an innovation in how the investigators
      deliver family-centered and participation-focused care. Study results will yield evidence for
      the effectiveness of the electronic intervention on parent activation, EI service plan focus,
      EI service use quantity, parent perceptions of EI service quality, and child functioning.
    

Detailed description: 
      Poor quality of care in early intervention (EI) is pervasive, particularly for vulnerable
      populations. Sub-optimal outcomes are perpetuated within this federally-funded, state
      administrated program due to significant cuts in federal per child appropriations. Optimizing
      EI outcomes will require ensuring the delivery of high value EI (i.e., providing services
      with the greatest reach, optimal outcomes, at the lowest cost). A lever to improve
      value-based EI is family-centered care, an evidence-based EI approach, which is grounded in
      family engagement and shared decision-making. Regrettably, the systematic implementation of
      strategies to empower families in this role are suboptimal, perpetuating poor outcomes and
      the failure of family-centered care. More than half of all EI enrolled families lack
      sufficient tools to engage in shared decision-making with EI practitioners when designing and
      monitoring the EI service plan. Therefore, if EI service quality and outcomes are going to be
      optimized, there is urgent need to equip families with a tool that will foster shared
      decision-making between the provider and family.

      As EI programs transition to electronic data capture systems for accountability and quality
      improvement, the implementation of evidence-based electronic assessments is a scalable
      strategy to strengthen family engagement in shared decision-making to design and monitor EI
      services. One evidence-based option is the Young Children's Participation in Environment
      Measure (YC-PEM) electronic patient-reported outcome (e-PRO). The YC-PEM e-PRO has not been
      implemented into routine practice for families to communicate areas of participation
      difficulty for shared decision-making about intervention priorities.

      The first aim is to conduct a community-based pragmatic trial of the Young Children's
      Participation and Environment Measure (YC-PEM), a valid electronic patient-reported outcome
      (e-PRO), at a single large, urban EI program to examine how this intervention is associated
      with: 1) EI service use breadth, intensity, and focus, 2) parent activation for shared
      decision making and engagement in EI services, 3) parent-reported EI service quality, and 3)
      gains in children's functioning.

      EI service coordinators will be randomized to intervention and control groups arms, and then
      eligible and interested parents on their assigned caseloads will be assigned to the
      intervention and control groups as part of their child's annual evaluation of progress.
      Intervention group subjects will complete the YC-PEM e-PRO before the child's annual
      intervention planning meeting. EI service plan focus (participation-focused goals in the
      plan), EI service amount (breadth and intensity), EI service quality (parent-reported
      activation for shared decision-making to design EI services and parent satisfaction with
      family-centeredness of EI service delivery), and child functioning will be evaluated via
      electronic records and patient-reported outcomes data collected at baseline, and 4 weeks, 6
      months, and 12 months.

      AIM 1. Examine the effects of the YC-PEM e-PRO intervention on EI stakeholder outcomes.

      (Aim 1a). Examine the effects of the YC-PEM e-PRO on EI parent activation, parent engagement
      in EI services, service plan focus, and service use breadth and intensity. The investigators
      will test two hypotheses in this first sub-aim. As compared to children receiving usual EI
      care, intervention group subjects will: H1: report higher activation for shared
      decision-making and parent engagement when planning and monitoring the child's EI care within
      12 months; H2: receive a greater breadth and intensity of participation-focused EI services
      within 12 months.

      (Aim 1b). Examine the effects of the YC-PEM e-PRO on parent report of EI service quality. As
      compared to usual care subjects, the investigators expect that parents in the intervention
      group will report greater satisfaction with: H1: enabling and partnership; H2: general and
      specific information exchange for shared decision-making; H3: coordinated and comprehensive
      EI care; and H4: respectful and supportive EI care.

      (Aim 1c). Examine the effects of the YC-PEM e-PRO on child functioning. As compared to usual
      EI care, intervention group children will: H1: demonstrate greater developmental gains, as
      measured by state-mandated and norm-referenced developmental tests done at EI entry and 12
      months. H2: demonstrate greater gains in functional skills, as measured by state-mandated
      outcomes data at EI entry and 12 months.
    

Intervention name(s): Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)
Intervention type(s): Behavioral
Intervention description(s): The Young Children's Participation in Environment Measure (YC-PEM) is an evidence-based option for comprehensive proxy assessment of a young child's current and desired participation in occupations across home, daycare, and community settings. The YC-PEM is an electronic patient-reported outcome (e-PRO) that provides individual caregivers a valid, reliable, and feasible way to communicate information about their child's current participation in home and community activities and areas of participation need. The gained information is then summarized and shared with the child's EI provide team to identify intervention priorities and goal attainment strategies in partnership with families. For quality improvement, EI programs can aggregate the YC-PEM e-PRO data to examine trends in participation as a function of EI service use. It is therefore a promising electronic health systems intervention to enhance the parent-practitioner relationship, and an NIH common data element for trials.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: early intervention; participation; shared decision-making; electronic; family-centered care