Giving Resources to lOw-income Children to Enhance RecoverY: Clinical Trial Identifier NCT06560229

Insurance Daily News

2024 SEP 03 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- Staff editors report on the newly launched clinical trial, NCT06560229, which has the following summary description: “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.”

As a matter of record, on August 20, 2024, NewsRx staff editors report that the available information provided by Children’s Hospital Medical Center, Cincinnati on this trial include:

Tracking Information

Trial Identifier	NCT06560229
First Submitted Date	August 15, 2024
First Posted Date	August 19, 2024
Results First Submitted Date	Not Provided
Results First Posted Date	Not Provided
Last Update Submitted Date	August 15, 2024
Last Update Posted Date	August 19, 2024
Primary Completion Date	July 31, 2026
Start Date	2024-08-19
Current Primary Outcome Measures	•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
Current Secondary Outcome Measures	•Primary Care Healthcare Utilization [ Time Frame: 30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months ] -- Planned and unplanned visits to primary care provider
	•Vaccine uptake at primary care clinic [ Time Frame: 30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months ] -- Immunization percentage as part of the Medicaid accountability measure
	•Recovery and return to normal routine [ Time Frame: 14-days after discharge ] -- Family-designed measure of recovery and return to normal routine
	•Post-Discharge Difficulty Coping Scale [ Time Frame: 14-days after discharge ] -- Post-Discharge Difficulty Coping Scale
	•Ability to pay for medications [ Time Frame: 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months ] -- Family-designed measure of difficulty obtaining medications after discharge
	•Parenting Stress Scale [ Time Frame: 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months ] -- Parenting Stress Scale
Other Outcome Measures	Not Provided
Change History	Complete list of historical revisions of study NCT06560229

Descriptive Information

Brief Title	Giving Resources to lOw-income Children to Enhance RecoverY
Official Title	Giving Resources to lOw-income Children to Enhance RecoverY
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.
Detailed Description	Not Provided
Study Type	INTERVENTIONAL
Study Phase	NA
Study Design	Allocation: RANDOMIZED
	Intervention Model: PARALLEL
	Primary Purpose: HEALTH_SERVICES_RESEARCH
	Masking: TRIPLE
Condition	Food Insecurity and Reutilization of Discharged Pediatric Patients and Their Families
Intervention	•OTHER: Grocery gift card
	Monthly $100 grocery gift cards for 12 months
Study Arms	•EXPERIMENTAL: Intervention
	Monthly $100 grocery gift cards for 12 months
	Interventions:
	⚬OTHER: Grocery gift card

Recruitment Information

Recruitment Status	NOT_YET_RECRUITING
Enrollment	400
Completion Date	2026-07-31
Primary Completion Date	July 31, 2026 (Final data collection date for primary outcome measure)
Eligibility	Inclusion Criteria: * Parent of a pediatric patient admitted to one of two units at our hospital with HealthVine insurance Exclusion Criteria: * Previous study participation
Sex/Gender	Sexes Eligible for Study: ALL
Ages	to
Accepts Healthy Volunteers	f
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries

Administrative Information

NCT Number	NCT06560229
Other Study ID Numbers	2024-0466
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
Plan to Share Data (IPD) Description	Not Provided
Collaborators	Not Provided
Investigators	Not Provided
Information Provided By	Children’s Hospital Medical Center, Cincinnati
Verification Date	2024-08