Clinical trial NCT05251051: Project Initiate: Transition to Community Therapy Services After NICU Discharge
Official title: Project INITIATE: Developing Community Collaborations to Improve Developmental Outcomes Through Prompt and Equitable Transition to Community Therapy Services in High-risk Newborn Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Delay
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: University of Chicago
First posted: 2022-02-22
Enrollment: 63
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Infants will be assigned to an intervention or control group based on the city of residence at discharge (Chicago or not-Chicago)
Primary purpose: TREATMENT

Brief summary: Project Initiate is a pilot study of early neuromotor outcomes in high risk newborn infants who are referred to Early Intervention services after NICU discharge. The investigators hypothesize that infants with Medicaid insurance who have prompt access to weekly post-discharge therapy services will have better early neuromotor function at 3 months corrected age and better parent satisfaction than infants who receive only care coordination to help with Early Intervention enrollment and locating outpatient transitional services as indicated.

Detailed description: Infants hospitalized in an neonatal intensive care unit with high risk illnesses typically receive physical therapy during the hospital stay to improve neuromotor function and promote optimal development. At discharge, infants residing in Illinois with high risk conditions are eligible for therapy services in the home through Illinois Early Intervention. The initiation of these services is typically delayed for several months or more after discharge and families with private insurance will often obtain transitional services. For children with Medicaid insurance, initiation of services is typically delayed or never occurs and there is concern that gaps in services may worsen outcomes and cause stress to parents.

The investigators hypothesize that infants with Medicaid insurance who have prompt access to weekly post-discharge therapy services will have better early neuromotor function at 3 months corrected age and better parent satisfaction than infants who receive only care coordination to help with Early Intervention enrollment and locating outpatient transitional services as indicated.

The aims of Project Initiate are:

Specific Aim 1: To pilot a NICU to home service delivery model for infants at high-risk for neuromotor complications with Medicaid Insurance.

Specific Aim 2: To test the feasibility of at NICU to home service delivery model for infants at high-risk for neuromotor complications.

Specific Aim 3: To compare motor and parental quality of life outcomes at 3-4 months corrected age in study participants and those who received standard discharge services.

Families of infants with high risk medical conditions qualifying for Early Intervention services will be recruited at NICU discharge and assigned to the intervention or control group based on the parents' city of residence (based on the availability of home therapists by location).

For the intervention group, therapy will be provided weekly within two weeks of discharge. Infants will be enrolled in Early Intervention, infants will receive care coordination to assist in engagement with the Early Intervention program and home services will be provided through the study until the Early intervention services are fully engaged or for 14 weeks, whichever comes first.

For the control group, infants will be enrolled in Early Intervention and infants will receive care coordination to assist in engagement with the Early Intervention program. If transitional services are recommended at discharge, the therapy care coordinator will assist families with these referrals until Early intervention is fully engaged r for 14 weeks, whichever comes first.

At discharge, neuromotor outcomes will be assessed. At 3 months corrected age, all infants will be evaluated in the Early Childhood clinic and their neuromotor outcome will be assessed. Parents will also complete quality of life surveys at discharge and at 3 months corrected age.

Eligibility criteria: Inclusion Criteria:

At-risk for developmental impairments (enrolled in Early Childhood Clinic and are automatically eligible for Illinois Early Intervention services)

Less that 45 weeks post-menstrual age (PMA) at discharge

English-speaking

Able to be identified and enrolled before discharge from the NICU

Exclusion Criteria:

Children in DCFS custody or children of parents who decline therapy services through the State of Illinois Early Intervention Program.

Primary outcomes:
measure: Test of Infant Motor Performance Score (TIMP)
timeFrame: 2-3 months (discharge to first developmental clinic visit)
measure: Time to initiation of Early Intervention therapy services
timeFrame: Discharge to EI initiation (1-6 months)
measure: Parent quality of life questionnaire assessed using the Peds QL Family Impact Module
timeFrame: 2-3 months
Secondary outcomes:
measure: General movements assessment-
timeFrame: At 3 months corrected age
measure: Hammersmith Infant Neurologic examination
timeFrame: At 3 months corrected age
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Chicago
country: United States
facility: Prentice Women's Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: Lurie Children's Hospital
name: Raye-Ann deRegnier, MD
role: PRINCIPAL_INVESTIGATOR
References: