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Clinical Trials/NCT06560229
NCT06560229Active, not recruitingNot Applicable

Giving Resources to lOw-income Children to Enhance RecoverY

Children's Hospital Medical Center, Cincinnati2 sites in 1 country400 target enrollmentStarted: September 27, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
400
Locations
2
Primary Endpoint
UDSA 6-question food insecurity survey

Study Overview

Brief Summary

The goal of this clinical trial is to learn if an intervention to provide food support to families who are part of a Medicaid Accountable Care Organization will provide benefits. The main question it aims to answer:

Does this monthly food support intervention reduce food insecurity and healthcare utilization in these patients.

Participants will complete surveys in the hospital, 14-days after discharge, and then quarterly for up to 18 months. Families randomized to the intervention group will receive monthly grocery gift cards for one year.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Parent of a pediatric patient admitted to one of two units at our hospital with HealthVine insurance

Exclusion Criteria

  • •Previous study participation

Arms & Interventions

Standard of Care

No Intervention

Can receive in-hospital social work referral if determined appropriate by clinical care team (also true for intervention group)

Intervention

Experimental

Monthly $100 grocery gift cards for 12 months

Intervention: Grocery gift card (Other)

Outcomes

Primary Outcomes

UDSA 6-question food insecurity survey

Time Frame: 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months

Adapted version of the UDSA 6-question food insecurity survey

Reutilization

Time Frame: 30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months

Validated measure of reutilization which includes unplanned readmission, return to the emergency department, or a visit to urgent care

Secondary Outcomes

  • Primary Care Healthcare Utilization(30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months)
  • Vaccine uptake at primary care clinic(30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months)
  • Post-Discharge Difficulty Coping Scale(14-days after discharge)
  • Perceived Stress Scale(14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months)
  • Recovery and return to normal routine(14-days after discharge)
  • Ability to pay for medications(14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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