Giving Resources to lOw-income Children to Enhance RecoverY (GROCERY)

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 Overview

• Status: Active, not recruiting
• Conditions: Discharged Pediatric Patients and Their Families
• Intervention / Treatment: Other: Grocery gift card

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Previous study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Monthly $100 grocery gift cards for 12 months	Other: Grocery gift card; Monthly $100 grocery gift cards for 12 months
No Intervention: Standard of Care; Can receive in-hospital social work referral if determined appropriate by clinical care team (also true for intervention group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reutilization	Validated measure of reutilization which includes unplanned readmission, return to the emergency department, or a visit to urgent care	30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
UDSA 6-question food insecurity survey	Adapted version of the UDSA 6-question food insecurity survey	14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Care Healthcare Utilization	Planned and unplanned visits to primary care provider	30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
Vaccine uptake at primary care clinic	Immunization percentage as part of the Medicaid accountability measure	30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
Recovery and return to normal routine	Family-designed measure of recovery and return to normal routine	14-days after discharge
Ability to pay for medications	Family-designed measure of difficulty obtaining medications after discharge	14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
Post-Discharge Difficulty Coping Scale	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.	14-days after discharge
Perceived Stress Scale	Perceived Stress Scale (PSS) uses a 5 point scaling format (0-4) with total scores ranging from 0 to 40. Higher scores represent higher perceived stress.	14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-0466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No