MedPath

Food-based Support for Hospitalized Children and Their Families

Not Applicable
Not yet recruiting
Conditions
Food Insecurity
Registration Number
NCT06946355
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
9119
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Primary Outcome Measures
NameTimeMethod
30-day urgent reutilization30 days post-discharge

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

Hunger during hospitalizationWithin 36 hours before discharge

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

Post-discharge hunger and food insecurity14 Days post-discharge

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

Secondary Outcome Measures
NameTimeMethod
30-day unplanned readmission30 Days post-discharge

Validated measure of unplanned readmission

30-day Emergency department utilization30 Days post-discharge

Emergency department utilization

Understanding of discharge instructions Confidence in care at home14 Days post-discharge

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

Return to normal routine14 Days post-discharge

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

Out of pocket expensesWithin 36 hours before discharge

Expenses paid by the family during the hospitalization

Ability to pay for medications14 Days post-discharge

Family-reported measure regarding difficulty paying for medications

Post-Discharge coping14 Days post-discharge

Post-Discharge Difficulty Coping Scale is measured at 14-day post-discharge phone call. Post-Discharge Coping Difficulty Scale uses an 11-point scaling format (0-10) with total scores ranging from 0 to 100. Higher scores represent greater coping difficulty.

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