Food-based Support for Hospitalized Children and Their Families (FRESH)

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Food Insecurity

Treatments: Other: In-hospital food support intervention; Other: Post-discharge food support intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06946355

1R01HD114702-01A1 (U.S. NIH Grant/Contract)

2023-0331

Details and patient eligibility

About

The goal of this clinical trial is to learn if an intervention to provide food support to families who are part of government or self-pay insurances will provide benefits. The main questions it aims to answer are:

• Determine the effect of implementing an in-hospital food support intervention for low-income parents on reutilization and family-centered outcomes.
• Among families with baseline food insecurity, determine the effectiveness of a post-discharge food support intervention and as-needed social work referral on reutilization and family-centered outcomes.

Researchers will compare the in-hospital food support intervention and will be rolled out to sequential hospital units. In addition, the post-discharge food support intervention will be compared to standard discharge.

Some participants will:

• Receive in-hospital meal cards or standard care during hospitalization
• Receive post-discharge food support intervention or standard discharge
• Complete a 14-day post discharge follow-up survey

Enrollment: 9,119 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All families of patients less than 21 years of age with Medicaid insurance or uninsured will be eligible

Exclusion criteria

• Patients admitted for end-of-life care, patients who will be discharged to a location other than home, patients who live independently, and patients in county custody.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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9,119 participants in 4 patient groups

Standard Care

No Intervention group

Description:

No post-discharge food support offered; no in-hospital food support offered; social work consults available per standard of care

Both In-Hosptial and Post-Discharge

Active Comparator group

Description:

The study team will provide two meals to up to two parents per day (for a maximum of four meals per day) in the hospital. The study team will provide families with a grocery gift card and frozen meals at the time of discharge.

Treatment:

Other: Post-discharge food support intervention

Other: In-hospital food support intervention

Post-Discharge No In-Hospital

Active Comparator group

Description:

The study team will provide families with a grocery gift card and frozen meals at the time of discharge. No in-hospital food support offered; social work consults available per standard of care.

Treatment:

Other: Post-discharge food support intervention

In-Hospital No Post-Discharge

Active Comparator group

Description:

The study team will provide two meals to up to two parents per day (for a maximum of four meals per day) in the hospital. No post-discharge food support offered; social work consults available per standard of care.

Treatment:

Other: In-hospital food support intervention