Chronic Conditions, Chronic Conditions, Multiple, Food Insecurity, Low-Income Population
Conditions
Keywords
chronic conditions, food insecurity, grocery benefit, low-income
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.
Interventions
OTHERGrocery Support Monthly Program
$80 monthly (adjusted by household size), re-loadable cash card for use at food retailers to purchase fresh and packaged foods, baby food and formula, and/or non-alcoholic drinks
OTHERGrocery Support One-Time Payment
No intervention is provided during the 12-month evaluation period. A $960 one-time (adjusted by household size) cash card for use at food retailers provided after the 12 month evaluation period to purchase fresh and packaged foods, baby food and formula, and/or non-alcoholic drinks
Sponsors
University of California, San Francisco
Covered California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Participants (n=6,975) were randomized into the intervention n=3,486) or active comparator (n=3,489) stratified by preferred language (English vs. non-English) and Covered California metal tier (Silver vs. Bronze). The intervention consists of a monthly or lump sum grocery support program provided in the form of a reloadable cash card usable at food retailers including those that sell non-food items.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* Negative for food insecurity via 2-item Hunger Vital Sign * Income ≥250% federal poverty level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaura M Gottlieb, MD, MPH
University of California, San Francisco
PRINCIPAL_INVESTIGATORCaroline Fichtenberg, PhD
University of California, San Francisco
PRINCIPAL_INVESTIGATORDanielle Hessler Jones, PhD
University of California, San Francisco
Outcome results
None listed