Development Delay Clinical Trial
Official title:
Implementation of Electronic Shared Decision-Making Support for Families to Design and Monitor Participation-Focused Early Intervention
Verified date | February 2023 |
Source | University of Illinois at Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 36 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Rocky Mountain Human Services | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | Rocky Mountain Human Services, University of Colorado, Denver, University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure of Processes of Care (MPOC-20) | 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) | |
Primary | Measure of Processes of Care (MPOC-20) | 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 | |
Primary | Measure of Processes of Care (MPOC-20) | 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 | |
Primary | Measure of Processes of Care (MPOC-20) | 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. | 12 months | |
Secondary | Parent Patient Activation Measure (P-PAM) | Parent activation for shared decision-making; 13 items assesses parent knowledge, skills, and confidence to manage their child's care | Baseline (pre-intervention) | |
Secondary | Parent Patient Activation Measure (P-PAM) | Parent activation for shared decision-making; 13 items assesses parent knowledge, skills, and confidence to manage their child's care | 4 weeks | |
Secondary | Parent Patient Activation Measure (P-PAM) | Parent activation for shared decision-making; 13 items assesses parent knowledge, skills, and confidence to manage their child's care | 6 months | |
Secondary | Parent Patient Activation Measure (P-PAM) | Parent activation for shared decision-making; 13 items assesses parent knowledge, skills, and confidence to manage their child's care | 12 months | |
Secondary | Parent Participation Engagement measure (PPEM) | Parent engagement in EI services; 5 items (5-point scale) assesses parent active engagement in their child's EI services | Baseline (pre-intervention) | |
Secondary | Parent Participation Engagement measure (PPEM) | Parent engagement in EI services; 5 items (5-point scale) assesses parent active engagement in their child's EI services | 4 weeks | |
Secondary | Parent Participation Engagement measure (PPEM) | Parent engagement in EI services; 5 items (5-point scale) assesses parent active engagement in their child's EI services | 6 months | |
Secondary | Parent Participation Engagement measure (PPEM) | Parent engagement in EI services; 5 items (5-point scale) assesses parent active engagement in their child's EI services | 12 months | |
Secondary | Early Intervention Service Use Quantity | 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 | |
Secondary | Early Intervention Service Use Quantity | 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 | |
Secondary | Early Intervention Service Plan Focus | 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. | 4 weeks | |
Secondary | Child Functioning | 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. | Baseline (pre-intervention) | |
Secondary | Child Functioning | 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 |
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