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

NCT ID: NCT06893003

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-03-03

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.

Detailed Description

Participants and setting

Participants include 20 high-risk parent-infant dyads hospitalized at CHLA. Enrolled infants and families will be randomized to receive Baby Bridge services either through telehealth or in-person visits. Parent-infant dyads will be enrolled at least 2 days before NICU discharge to enable rapport to be established (between the Baby Bridge therapist and family) through a visit to the NICU when possible and via telephone, text or email messaging when an in-person visit is not possible prior to discharge. This first contact will be attempted to be in-person in the NICU for both the telehealth and in-person groups. Enrolled infants and families will then have a Baby Bridge telehealth or in-person visit scheduled within one week of discharge (depending on their group assignment). Subsequent individual weekly visits will be adapted to in-person or telehealth (varying from assigned group) when needed or deemed appropriate (requested by the family or therapist or when an in-person visit is felt to improve the quality of the therapy session). Weekly Baby Bridge programming will be conducted until other therapy through the state-wide early intervention program commences, as in the infant begins receiving therapy services as recommended. Investigators will also track rates of enrollment, rates and reasons for any cancellations, and completion of the program (defined as being seen until community-based early intervention services commenced). Infants will be withdrawn if they are transferred to another hospital prior to discharge or if they are readmitted to the hospital and additional contact was not possible or feasible.

Sociodemographic and medical data will be collected from the electronic medical record for each dyad enrolled to better understand differences between groups as well as to define sample characteristics. Sociodemographic factors collected will include: infant race, insurance type (public or private), maternal age, number of siblings, home distance from the hospital, and categorization of home residence (urban with <3,000 people per square mile, suburban with between 1,000 and 3,000 people per square mile, or rural with <1,000 people per square mile). Medical factors collected will include: estimated gestational age at birth, the primary condition of the infant (congenital anomaly, preterm birth, or neurological condition not related to preterm birth or congenital anomaly), number of days of endotracheal intubation, number of days of hospitalization, and whether or not the infant was orally feeding at time of hospital discharge.

In-person group assignment 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.

Telehealth group assignment 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.

Implementation outcomes The primary outcome of interest for this study will be cost difference between telehealth and in-person visits of the Baby Bridge program. Investigators also plan to investigate implementation outcomes of adoptability (enrollment rate), feasibility (whether program tenets were followed), adaptations, and acceptability (parent satisfaction).

Conditions

Prematurity Complications; NICU Infants; Early Intervention; Telehealth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telehealth Baby Bridge model

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.

Group Type: EXPERIMENTAL

Baby Bridge

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Baby Bridge

Intervention Type: 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.

Interventions

Baby Bridge

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Roberta Pineda

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberta Pineda, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Children's Hospital of Los Angeles

Los Angeles, California, United States

University of Southern California

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AOTFIR21

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AOTFIR21

Identifier Type: -

Identifier Source: org_study_id