Evaluating Covered California's Grocery Support Program
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 6,975
- 试验地点
- 2
- 主要终点
- Change in food insecurity status
研究概览
简要总结
This is a pragmatic randomized controlled trial (RCT) of Covered California's Grocery Support Program. This pragmatic RCT will test the efficacy of providing a monthly food card benefit for adults with food insecurity, a chronic condition, and incomes below 250% of the federal poverty level (FPL) compared with a group who receives a lump sum payment.
详细描述
In 2024, Covered California initiated multiple Population Health Investments (PopHIs) based on funds collected by participating plans if they failed to meet a set of quality benchmarks related to diabetes control, blood pressure control, colorectal cancer screening, and childhood immunizations. One priority area for the PopHIs was food insecurity among patients who manage chronic diseases. Food insecurity, defined by the United States Department of Agriculture (USDA) as a "lack of access to enough food for an active, healthy life" effects 18% of newly enrolled Covered California members. Food insecurity is more pronounced and is associated with poor clinical outcomes and more avoidable and costly healthcare utilization among individuals who manage chronic disease. The burden of disease is high among Covered California members; for every 1,000 Covered California enrollees with one or more years of continuous enrollment, 390 have a chronic disease diagnosis. The goal of the proposed research is to evaluate the impact of a 12-month grocery support program on participant food insecurity and other outcomes compared to a single payment at the end of 12 months. Participants were invited to enroll in the program if they were active members of Covered California at the time of enrollment, and had 1) a documented chronic condition, 2) food insecurity measured using the validated two-item screener), and 3) an income at or below 250% of the FPL. Participants were randomly assigned to receive either an $80 reusable semi-restricted cash card re-loaded monthly for one year or a one-time cash card of $960 (payments in both arms adjusted based on household size). Retailers are restricted to food retailers, which includes retailers that do sell non-food goods. The study has four main data sources: survey data from surveys repeated at baseline and 12-months; cash card spending data; qualitative participant interview data and claims data.
Specific Aims are to:
Aim 1 - To evaluate the impact of the grocery support program on participant food insecurity and other dietary outcomes.
H1: Participants who receive the monthly payment will have decreased rates of food insecurity and improved dietary outcomes 12-months after participating compared to participants who do not receive the monthly payment.
Aim 2 - To assess the impact of the grocery support program on self-rated health, healthcare experiences, and social risks and other quality of life measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Members of the household are eligible to participate if the recruited participant:
- •Active Covered California member
- •Adult >= 18 years of age
- •Has a chronic condition identifiable in Covered California's medical claims
- •Screened positive for food insecurity via 2-item Hunger Vital Sign
- •Income <250% federal poverty level
排除标准
- •Negative for food insecurity via 2-item Hunger Vital Sign
- •Income ≥250% federal poverty level
研究组 & 干预措施
One-time grocery support payment
At the end of the study period (12 months), active comparator participants are provided a lump sum payment of $960 (adjusted by household size) as a re-loadable cash card to use at food retailers. No intervention is provided during the 12-month evaluation period.
干预措施: Grocery Support One-Time Payment (Other)
Monthly grocery support program
The intervention entails the provision of an $80 monthly payment (adjusted by household size) in the form of a re-loadable cash card to be used at food retailers including food retailers who sell non-food item.
干预措施: Grocery Support Monthly Program (Other)
结局指标
主要结局
Change in food insecurity status
时间窗: Baseline, 12 months
Measured by 2-item Hunger Vital Sign, a validated tool to assess food insecurity. Responses that indicate that food sometimes or often did not last or ran out before the end of the month indicate food insecurity
Change in food insecurity status
时间窗: Baseline, 12 months
Measured by 2-item Hunger Vital Sign, a validated tool to assess food insecurity. Responses that indicate that food sometimes or often did not last or ran out before the end of the month indicate food insecurity
次要结局
- Change in nutrition security(Baseline, 12 months)
- Change in diet quality(Baseline, 12 months)
- Proportion of participants with acute health care utilization(2 years before study start until 12 months after)
- Proportion of hospital admissions(2 years before study start until 12 months after)
- Proportion of hospital readmissions(2 years before study start until 13 months after)
- Number of outpatient visits(2 years before study start until 12 months after)
- Change in self-rated physical and mental health(Baseline, 12 months)