- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04562038
Implementation of Electronic Shared Decision-Making Support for Early Intervention
Implementation of Electronic Shared Decision-Making Support for Families to Design and Monitor Participation-Focused Early Intervention
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vera C Kaelin, MSc
- Phone Number: 312-413-2850
- Email: vkaeli2@uic.edu
Study Contact Backup
- Name: Vivian Villegas, MS
- Phone Number: 312-413-2850
- Email: vvilleg2@uic.edu
Study Locations
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Colorado
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Denver, Colorado, United States, 80231
- Rocky Mountain Human Services
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Caregiver identifies as a parent or legal guardian of a child enrolled in early intervention
- Caregiver is at least 18 years old
- Caregiver reads, writes, and speaks English
- Caregiver has internet and telephone access
- Caregiver has a child who has received early intervention services for 3 or more months
Exclusion Criteria:
- Caregiver is not the parent or legal guardian of a child enrolled in early intervention
- Caregiver is 0-17 years old
- Caregiver does not read, write, or speak English
- Caregiver does not have internet or telephone access
- Caregiver does not have a child who has received early intervention services for 3 or more months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: YC-PEM e-PRO
Participants are administered an electronic patient-reported outcome measure to obtain information about parent priorities, and they obtain a summary report of their responses to share with their early intervention team for discussion during the annual IFSP meeting.
|
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.
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No Intervention: Family Assessment
Participants are scheduled to complete a semi-structured family interview to obtain information about parent priorities, for use during the annual IFSP meeting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of Processes of Care (MPOC-20)
Time Frame: Baseline (pre-intervention)
|
Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.
|
Baseline (pre-intervention)
|
Measure of Processes of Care (MPOC-20)
Time Frame: 4 weeks
|
Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.
|
4 weeks
|
Measure of Processes of Care (MPOC-20)
Time Frame: 6 months
|
Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.
|
6 months
|
Measure of Processes of Care (MPOC-20)
Time Frame: 12 months
|
Parent-reported EI quality; 20 items (7-point scale) assesses these domains of family-centered care: 1) enabling and partnership; 2) providing general and specific information; 3) coordinated and comprehensive care; and 4) respectful and supportive care.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent Patient Activation Measure (P-PAM)
Time Frame: Baseline (pre-intervention)
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Parent activation for shared decision-making; 13 items assesses parent knowledge, skills, and confidence to manage their child's care
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Baseline (pre-intervention)
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Parent Patient Activation Measure (P-PAM)
Time Frame: 4 weeks
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Parent activation for shared decision-making; 13 items assesses parent knowledge, skills, and confidence to manage their child's care
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4 weeks
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Parent Patient Activation Measure (P-PAM)
Time Frame: 6 months
|
Parent activation for shared decision-making; 13 items assesses parent knowledge, skills, and confidence to manage their child's care
|
6 months
|
Parent Patient Activation Measure (P-PAM)
Time Frame: 12 months
|
Parent activation for shared decision-making; 13 items assesses parent knowledge, skills, and confidence to manage their child's care
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12 months
|
Parent Participation Engagement measure (PPEM)
Time Frame: Baseline (pre-intervention)
|
Parent engagement in EI services; 5 items (5-point scale) assesses parent active engagement in their child's EI services
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Baseline (pre-intervention)
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Parent Participation Engagement measure (PPEM)
Time Frame: 4 weeks
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Parent engagement in EI services; 5 items (5-point scale) assesses parent active engagement in their child's EI services
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4 weeks
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Parent Participation Engagement measure (PPEM)
Time Frame: 6 months
|
Parent engagement in EI services; 5 items (5-point scale) assesses parent active engagement in their child's EI services
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6 months
|
Parent Participation Engagement measure (PPEM)
Time Frame: 12 months
|
Parent engagement in EI services; 5 items (5-point scale) assesses parent active engagement in their child's EI services
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12 months
|
Early Intervention Service Use Quantity
Time Frame: 1 month
|
EI service use quantity will be captured according to service breadth and intensity.
EI service breadth will be derived as a count of core EI services received (1, 2, 3+): physical therapy (PT), occupational therapy (OT), speech therapy (ST), developmental intervention (DI).
For service intensity, estimates of service amount (hours) and service duration (months) from the service record will be used to derive an estimate of service use intensity (hours per month).
|
1 month
|
Early Intervention Service Use Quantity
Time Frame: 12 months
|
EI service use quantity will be captured according to service breadth and intensity.
EI service breadth will be derived as a count of core EI services received (1, 2, 3+): physical therapy (PT), occupational therapy (OT), speech therapy (ST), developmental intervention (DI).
For service intensity, estimates of service amount (hours) and service duration (months) from the service record will be used to derive an estimate of service use intensity (hours per month).
|
12 months
|
Early Intervention Service Plan Focus
Time Frame: 4 weeks
|
Record abstraction will be used to extract data on the child's service plan focus (i.e., EI service goals).
These data will be coded using established quality criteria, to derive an estimate of the proportion of participation-focused goals in the EI service plan.
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4 weeks
|
Child Functioning
Time Frame: Baseline (pre-intervention)
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Child Outcomes Summary (COS) scores that capture the child's functional capabilities.
COS scores are a consensus rating by the EI team based on developmental scores and practitioner and parent perceptions of child function.
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Baseline (pre-intervention)
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Child Functioning
Time Frame: 12 months
|
Child Outcomes Summary (COS) scores that capture the child's functional capabilities.
COS scores are a consensus rating by the EI team based on developmental scores and practitioner and parent perceptions of child function.
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mary A Khetani, University of Illinois at Chicago
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-0555
- AOTFIR20KHETANI (Other Grant/Funding Number: American Occupational Therapy Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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