Project Initiate: Transition to Community Therapy Services After NICU Discharge

NCT ID: NCT05251051

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2024-09-30

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.

Conditions

Motor Delay

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

At NICU discharge, infants will be referred to Illinois Early Intervention. A coordinator (the navigator) will assist families in engaging with Early Intervention and completing all enrollment requirements.

At NICU discharge, infants will be provided with standard home pediatric therapy services weekly for up to 14 weeks. These will be initiated within 2 weeks of discharge.

Group Type: ACTIVE_COMPARATOR

pediatric physical therapy

Intervention Type: BEHAVIORAL

Pediatric physical therapists will provide weekly home therapy using standard of care/best evidence procedures

Care Coordination

Intervention Type: OTHER

A navigator will be assigned who will assist families in obtaining Early Intervention services and other therapy services if needed

Control Group

At NICU discharge, infants will be referred to Illinois Early Intervention. A coordinator (the navigator) will assist families in engaging with Early Intervention and completing all enrollment requirements. If transitional services were recommended by the NICU providers, the navigator will help families identify these services and obtain the necessary referrals.

Group Type: OTHER

Care Coordination

Intervention Type: OTHER

A navigator will be assigned who will assist families in obtaining Early Intervention services and other therapy services if needed

Interventions

pediatric physical therapy

Pediatric physical therapists will provide weekly home therapy using standard of care/best evidence procedures

Intervention Type: BEHAVIORAL

Care Coordination

A navigator will be assigned who will assist families in obtaining Early Intervention services and other therapy services if needed

Intervention Type: OTHER

Other Intervention Names

Navigation

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Raye Ann deRegnier

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raye-Ann deRegnier, MD

Role: PRINCIPAL_INVESTIGATOR

Lurie Children's Hospital

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Lurie Children's Hospital

Chicago, Illinois, United States

Prentice Women's Hospital

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2021-4541

Identifier Type: -

Identifier Source: org_study_id