Project Initiate: Transition to Community Therapy Services After NICU Discharge

Motor Delay Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05251051
• Other study ID #: 2021-4541
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2022
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Raye-Ann deRegnier, MD
• Phone: 3120227-4190
• Email: rderegnier[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: June 30, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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.

Related Conditions & MeSH terms

• Motor Delay

Intervention

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

Other:
• Care Coordination
A navigator will be assigned who will assist families in obtaining Early Intervention services and other therapy services if needed

Locations

Country	Name	City	State
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	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test of Infant Motor Performance Score (TIMP)	The TIMP is a motor evaluation conducted by a physical therapist. The test is scored and the scores are converted to standard deviations based on the child's age. Changes in the infant's TIMP standard deviation score from discharge to 3 months of age, corrected for prematurity, assessed by an physical therapist blinded to the intervention group.	2-3 months (discharge to first developmental clinic visit)
Primary	Time to initiation of Early Intervention therapy services	The time from discharge to the first Early Intervention home therapy service will be assessed	Discharge to EI initiation (1-6 months)
Primary	Parent quality of life questionnaire assessed using the Peds QL Family Impact Module	Parent quality of life will be assessed at the beginning and end of the study. This test asks parents to rate their quality of life in 6 categories. Each item is scored on a Likert Scale from 0-4 and then reverse transformed to a score from 0-100. The investigators will use an overall score averaged from the 6 categories as an outcome, as well as scores for the individual categories. Higher scores indicated better parent reported quality of life.	2-3 months
Secondary	General movements assessment-	Motor optimality scores will be obtained from observation of standard videos and rated by blinded trained observers. Motor optimality scores can range from 5-28 with higher scores indicating better motor optimality.	At 3 months corrected age
Secondary	Hammersmith Infant Neurologic examination	A neurologic examination performed by blinded observers who have been trained (physical therapists or physicians). Each item (n=26) is scored from 0-3 points. Higher scores indicate better neurologic function with a maximum score of 78.	At 3 months corrected age