Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD114702-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | No Intervention | No post-discharge food support offered; no in-hospital food support offered; social work consults available per standard of care | |
| Both In-Hosptial and Post-Discharge | Active Comparator | The study team will provide two meals to up to two parents per day (for a maximum of four meals per day) in the hospital. The study team will provide families with a grocery gift card and frozen meals at the time of discharge. |
|
| Post-Discharge No In-Hospital | Active Comparator | The study team will provide families with a grocery gift card and frozen meals at the time of discharge. No in-hospital food support offered; social work consults available per standard of care. |
|
| In-Hospital No Post-Discharge | Active Comparator | The study team will provide two meals to up to two parents per day (for a maximum of four meals per day) in the hospital. No post-discharge food support offered; social work consults available per standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-hospital food support intervention | Other | The in-hospital food support intervention will provide two meals for up to two parents per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day urgent reutilization | Validated measure of unplanned readmission/ED/urgent care use via electronic health record (EHR) | 30 days post-discharge |
| Hunger during hospitalization | 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.
| Within 36 hours before discharge |
| Post-discharge hunger and food insecurity | 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.
| 14 Days post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day unplanned readmission | Validated measure of unplanned readmission | 30 Days post-discharge |
| 30-day Emergency department utilization | Emergency department utilization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathy Auger | Contact | +15138033234 | katherine.auger@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Kathy Auger | katherine.auger@cchmc.org | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Post-discharge food support intervention | Other | The post-discharge intervention will provide families with grocery gift cards and frozen meals at the time of discharge. |
|
| 30 Days post-discharge |
| Understanding of discharge instructions Confidence in care at home | Pediatric Transition Experience Measure (P-TEM)-Transition Preparation Domain | 14 Days post-discharge |
| Return to normal routine | Family designed measure that assesses a family's return to normal routines | 14 Days post-discharge |
| Post-Discharge coping | 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. | 14 Days post-discharge |
| Out of pocket expenses | Expenses paid by the family during the hospitalization | Within 36 hours before discharge |
| Ability to pay for medications | Family-reported measure regarding difficulty paying for medications | 14 Days post-discharge |