Evaluating Covered California's Grocery Support Program
- Conditions
- Chronic Conditions, MultipleChronic ConditionsFood InsecurityLow-Income Population
- Registration Number
- NCT07215897
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed Description
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.
H1: Participants who receive the monthly payment will have improved self-rated health, healthcare experiences, and quality of life, and fewer social risks compared to participants who do not receive the monthly payment.
Aim 3 - To analyze the impact of the grocery support program on participant's health utilization and outcomes.
H1: Relative to participants who do not receive the monthly payment, Grocery Support Program participants will have fewer hospitalizations and Emergency Department (ED) visits and more primary care visits.
H2: Relative to participants who do not receive the monthly payment, Grocery Support Program participants will have greater improvements in chronic disease clinical outcomes.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 6975
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
- Negative for food insecurity via 2-item Hunger Vital Sign
- Income ≥250% federal poverty level
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in food insecurity status 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
- Secondary Outcome Measures
Name Time Method Change in nutrition security Baseline, 12 months Measured using the one-item response allowing calculation of the proportion of participants that report difficulty getting and eating healthy foods.
Change in diet quality Baseline, 12 months Measured using the self-reported number of servings of vegetables or number of days where higher fat foods were consumed during the past 7 days, by study arm
Proportion of participants with acute health care utilization 2 years before study start until 12 months after Proportion of participants that used the emergency department (ED) or had a treat and release ED or observation room visit and number of visits by study arm
Proportion of hospital admissions 2 years before study start until 12 months after Proportion of participants who were hospitalized at least once and count of total hospitalizations from baseline to 12 months by study arm
Proportion of hospital readmissions 2 years before study start until 13 months after Proportion of participants who were re-hospitalized within 30-days of the index hospitalization by study arm
Number of outpatient visits 2 years before study start until 12 months after Number of primary care provider, specialist, mental health, and addiction medicine visits across the 12 month study period by study arm
Change in self-rated physical and mental health Baseline, 12 months Measured as the change in self-rated overall, physical, and mental health reported on a 0 to 5-response (excellent to poor) scale by study arm. Higher score corresponds to better self-rated health
Trial Locations
- Locations (1)
Social Interventions Research and Evaluation Network (SIREN), University of California, San Francisco
🇺🇸San Francisco, California, United States
Social Interventions Research and Evaluation Network (SIREN), University of California, San Francisco🇺🇸San Francisco, California, United States