A Pilot Study Comparing Telehealth and In-Person Therapy Service Delivery Following NICU Discharge

NCT06893003 | Completed

• 1 other identifier: AOTFIR21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

20 high-risk parent-infant dyads hospitalized in a 58-bed level IV NICU will be randomized to either receive Telehealth or in-person Baby Bridge services. Baby Bridge is a program to bridge the gap between NICU discharge and initiation of community-based early intervention services. Weekly therapy services are provided in the child's home, either via telehealth or in-person. An in-person evaluation in the NICU is attempted for each child prior to NICU discharge. Cost, adoptability, feasibility, adaptations, and acceptability amongst caregivers will be compared between the two groups.

Conditions

Prematurity Complications; NICU Infants; Early Intervention; Telehealth

Keywords

Baby Bridge; Early intervention; Telehealth

Outcome Measures

Primary Outcomes (1)

• Cost of the Baby Bridge program

  For the purposes of this project, we estimated costs associated with each Baby Bridge visit. We did not assess cost across group assignment, due to the allowed adaptations to each visit type. Cost was defined in relation to the organizational cost of providing Baby Bridge visits and included the time that the therapist spent conducting therapy sessions (billable time), administrative time (documentation, communication with families), driving (for in-person visits), and mileage reimbursement.

  From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants)

Secondary Outcomes (7)

• Adoptability of the Baby Bridge program

  From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants

• Feasibility of the Baby Bridge program - Timing

  From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants

• Feasibility of the Baby Bridge program - Frequency

  From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants

• Feasibility of the Baby Bridge program - Completion rate

  From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants

• Feasibility of the Baby Bridge program - Timing of transition

  From first Baby Bridge visit to last Baby Bridge visit for each infant (approx 12 weeks but varies significantly between infants

Study Arms (2)

Telehealth Baby Bridge model

EXPERIMENTAL

For those assigned to the telehealth Baby Bridge group, a first telehealth visit will be scheduled within one week of discharge, and weekly telehealth visits will be scheduled thereafter. However, parents will be informed that in-person visits are an option when needs arise. Adaptations from a telehealth visit to an in-person visit will be made in the event of therapist clinical judgment due to the medical complexity or feeding/tonal abnormalities of the infant and parent preference or rapport building. Visit adaptations will be tracked along with the reasoning for them.

Other: Baby Bridge

In-Person Baby Bridge model

ACTIVE COMPARATOR

For those assigned to the in-person Baby Bridge group, the first visit will be scheduled in the home within one week of NICU discharge, and attempts will be made to see the infant weekly in the home environment for a one-hour therapy session. Scheduled visits will be confirmed with families via text messaging the day before each visit. Visits will be rescheduled to telehealth in the event of therapist illness, parent preference or parent/child illness, or distance or therapist schedule limitations. Changes of visits from in-person to telehealth will be tracked along with their reasoning.

Other: Baby Bridge

Interventions

Baby Bridge OTHER

The Baby Bridge program is an evidence-based implementation strategy aimed at enhancing early and continuous therapy services following NICU discharge for infants with alterations in neurodevelopment. The Baby Bridge program utilizes an occupational or physical therapist to see the infant and family in the NICU prior to discharge, complete a comprehensive neurodevelopmental and feeding assessment to inform targeted interventions, and provide early therapy services in the home environment within one week of discharge and weekly thereafter, until other community-based services commence. While most of the program occurs after NICU discharge, a hallmark of the Baby Bridge program is that families establish rapport with the therapist while the infant is still in the NICU. The therapist also educates the family on ways to support their infant's development between sessions and offers support and assistance during the transition from hospital to home.

In-Person Baby Bridge model; Telehealth Baby Bridge model

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Hospitalized in the NICU for \>7 days
• Received a referral for early intervention at time of NICU discharge
• Was referred to program at least 48 hours before NICU discharge

You may not qualify if:

• Chronological age \>6 months at time of NICU discharge
• Non-English speakers
• Those discharging home to a different state/country

Sponsors & Collaborators

• University of Southern California: lead
• Children's Hospital Los Angeles: collaborator

Study Sites (2)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

University of Southern California

Los Angeles, California, 90089, United States

Location

Study Officials

• Roberta Pineda, PhD, OTR/L

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 25, 2025
• Study Start: May 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: March 3, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)