Discharged Pediatric Patients and Their FamiliesGROCERYNCT06560229
Giving Resources to lOw-income Children to Enhance RecoverY
A study testing Grocery gift card in people with Discharged Pediatric Patients and Their Families, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Discharged Pediatric Patients and Their Families
- What is being tested?
- Grocery gift card
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent of a pediatric patient admitted to one of two units at our hospital with HealthVine insurance
Who cannot join
- Previous study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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.
- Being tested
- Grocery gift card
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grocery gift cardOther
Monthly $100 grocery gift cards for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Monthly $100 grocery gift cards for 12 months Receives: Other: Grocery gift card |
| Standard of Care | No intervention | Can receive in-hospital social work referral if determined appropriate by clinical care team (also true for intervention group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reutilization
Validated measure of reutilization which includes unplanned readmission, return to the emergency department, or a visit to urgent care
Measured: 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
Measured: 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
Secondary outcomes (6)
Primary Care Healthcare Utilization
Planned and unplanned visits to primary care provider
Measured: 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
Measured: 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
Measured: 14-days after discharge
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.
Measured: 14-days after discharge
Ability to pay for medications
Family-designed measure of difficulty obtaining medications after discharge
Measured: 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
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.
Measured: 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start27 Sep 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discharged Pediatric Patients and Their FamiliesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560229
- Sponsor's protocol ID
- 2024-0466
- Acronym
- GROCERY
- Status last verified
- Dec 2025
- First submitted
- 15 Aug 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giving Resources to lOw-income Children to Enhance RecoverY
- ClinicalTrials.gov ID
- NCT06560229
- Acronym / sponsor ID
- GROCERY / 2024-0466
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Grocery gift cardMonthly $100 grocery gift cards for 12 months |
| Standard of Care | No intervention | –Can receive in-hospital social work referral if determined appropriate by clinical care team (also true for intervention group) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parent of a pediatric patient admitted to one of two units at our hospital with HealthVine insurance
Key exclusion criteria (1 listed)
- Previous study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grocery gift cardMonthly $100 grocery gift cards for 12 months | Other | Intervention |
Primary outcome
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
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
6 secondary outcomes
Primary Care Healthcare Utilization
Time frame: 30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
Vaccine uptake at primary care clinic
Time frame: 30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
Recovery and return to normal routine
Time frame: 14-days after discharge
Post-Discharge Difficulty Coping Scale
Time frame: 14-days after discharge
Ability to pay for medications
Time frame: 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
Perceived Stress Scale
Time frame: 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grocery gift card in people with Discharged Pediatric Patients and Their Families, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reutilization (time frame: 30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.