Food-based Randomized Trial for Enhancing Support of Hospitalized Children and Their Families
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9,119
- 试验地点
- 2
- 主要终点
- 30-day urgent reutilization
研究概览
简要总结
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:
- Determine the effect of implementing an in-hospital food support intervention for low-income parents on reutilization and family-centered outcomes.
- Among families with baseline food insecurity, determine the effectiveness of a post-discharge food support intervention and as-needed social work referral on reutilization and family-centered outcomes.
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:
- Receive in-hospital meal cards or standard care during hospitalization
- Receive post-discharge food support intervention or standard discharge
- Complete a 14-day post discharge follow-up survey
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All families of patients less than 21 years of age with Medicaid insurance or uninsured will be eligible
排除标准
- •Patients admitted for end-of-life care, patients who will be discharged to a location other than home, patients who live independently, and patients in county custody.
研究组 & 干预措施
Standard Care
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
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.
干预措施: In-hospital food support intervention (Other)
Both In-Hosptial and Post-Discharge
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.
干预措施: Post-discharge food support intervention (Other)
Post-Discharge No In-Hospital
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.
干预措施: Post-discharge food support intervention (Other)
In-Hospital No Post-Discharge
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.
干预措施: In-hospital food support intervention (Other)
结局指标
主要结局
30-day urgent reutilization
时间窗: 30 days post-discharge
Validated measure of unplanned readmission/ED/urgent care use via electronic health record (EHR)
Hunger during hospitalization
时间窗: Within 36 hours before discharge
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. * Raw score 0-1-High food security * Raw score 2-4-Low food security * Raw score 5-6-Very low food security
Post-discharge hunger and food insecurity
时间窗: 14 Days post-discharge
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. * Raw score 0-1-High food security * Raw score 2-4-Low food security * Raw score 5-6-Very low food security
次要结局
- 30-day unplanned readmission(30 Days post-discharge)
- 30-day Emergency department utilization(30 Days post-discharge)
- Understanding of discharge instructions Confidence in care at home(14 Days post-discharge)
- Return to normal routine(14 Days post-discharge)
- Out of pocket expenses(Within 36 hours before discharge)
- Ability to pay for medications(14 Days post-discharge)
- Post-Discharge coping(14 Days post-discharge)