Food-based Support for Hospitalized Children and Their Families

Trial statusEnrolling by invitation
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be currently admitted to a hospital unit where the study is active

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

Disqualifiers

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

Design model

Factorial

Treatments tested in this trial

  • In-hospital food support intervention

    Other intervention

    The in-hospital food support intervention will provide two meals for up to two parents per day.

  • Post-discharge food support intervention

    Other intervention

    The post-discharge intervention will provide families with grocery gift cards and frozen meals at the time of discharge.

Treatment groups

9,119 Participants
are divided into 4 treatment groups
Group A: Standard CareNo intervention 0 interventions
Group B: Both In-Hosptial and Post-DischargeActive comparator 2 interventions
Group C: Post-Discharge No In-HospitalActive comparator 1 intervention
Group D: In-Hospital No Post-DischargeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

30-day urgent reutilization

Validated measure of unplanned readmission/ED/urgent care use via electronic health record (EHR)

Time frame
30 days post-discharge
2

Hunger during hospitalization

USDA Six-Item Short Form of the Food Security Survey Module, adapted to measure hunger in hospital. Families with lower scores are less likely to experience food insecurity. The family's level of food insecurity increases with the score. * Raw score 0-1-High food security * Raw score 2-4-Low food security * Raw score 5-6-Very low food security

Time frame
Within 36 hours before discharge
3

Post-discharge hunger and food insecurity

USDA Six-Item Short Form of the Food Security Survey Module. Families with lower scores are less likely to experience food insecurity. The family's level of food insecurity increases with the score. * Raw score 0-1-High food security * Raw score 2-4-Low food security * Raw score 5-6-Very low food security

Time frame
14 Days post-discharge

Secondary outcomes

1

30-day unplanned readmission

Validated measure of unplanned readmission

Time frame
30 Days post-discharge
2

30-day Emergency department utilization

Emergency department utilization

Time frame
30 Days post-discharge
3

Understanding of discharge instructions Confidence in care at home

Pediatric Transition Experience Measure (P-TEM)-Transition Preparation Domain

Time frame
14 Days post-discharge
4

Return to normal routine

Family designed measure that assesses a family's return to normal routines

Time frame
14 Days post-discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator