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Clinical Trials/NCT04017624
NCT04017624
Withdrawn
Not Applicable

A Mobile Fresh Produce Market Intervention to Reduce Food Insecurity and Health Care Utilization Among Primary Care Patients in a Medicaid Accountable Care Organization: Randomized Pilot Study

Boston Medical Center1 site in 1 countryNovember 2020
ConditionsFood Insecurity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Food Insecurity
Sponsor
Boston Medical Center
Locations
1
Primary Endpoint
Change in reported food insecurity based on the United States Department of Agriculture (USDA) food insecurity module
Status
Withdrawn
Last Updated
5 years ago

Overview

Brief Summary

This research is a randomized pilot study of an intervention to address food insecurity among intermediate risk Boston Accountable Care Organization (BACO) members receiving primary care at Boston Medical Center (BMC).

The investigators propose a parallel group, randomized pilot study among intermediate risk Medicaid ACO patients at BMC who have experienced food insecurity in the past 12 months, with a total enrollment of 120 participants (N=120). Half of the pilot study participants (n=60) will receive usual care: tailored printed paper referral guides to address health-related social needs, including resources for food insecurity (via the Health System's THRIVE Screening & Referral Program) and referrals to Boston Medical Center's Preventative Food Pantry. The other half (n=60) will receive access to a mobile fresh produce market and a monthly stipend to purchase items available on the mobile food trucks.

This pilot study will partner with Fresh Truck, a Boston-based 501(c)(3) organization that deploys mobile fresh produce trucks throughout Boston neighborhoods. Fresh Truck recently launched a new system, called 'Fresh Connect,' which addresses affordability as a barrier to healthy eating. 'Fresh Connect' enables healthcare systems to pay for fresh produce purchased by their patients from the Fresh Truck mobile markets.

The study protocol comprises three steps:

  • Risk stratification before consent process to determine if the patient, at baseline, is within the top 3-20% of cost and utilization among BACO members. (This process is part of usual care operations in the Health System for ACO members).
  • Of BACO patients identified as intermediate risk, patients will be screened for proximity to Fresh Truck mobile markets (zip code is among current Fresh Truck service area), nutritional need (food insecurity identified in the last 12 months), and not documented as housing insecure.
  • Half the pilot study population will receive access to a mobile fresh food market intervention, Fresh Truck, and a stipend to purchase fresh produce aboard the trucks. The other half will receive usual care.

Pilot study participation is 6 months and will include collection and measurement of data from the following sources: baseline interview; final (6-months post-enrollment) interview, electronic medical records (EMR), BMC Clinical Data Warehouse (BMC CDW), and BMC HealthNet Plan (BMCHP) claims.

Registry
clinicaltrials.gov
Start Date
November 2020
End Date
November 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Be within the 3rd to 20th percentile for healthcare utilization and cost among BACO membership at the time of enrollment into the pilot study
  • Zip code that is in one of Fresh Truck's current services areas
  • Documented as experiencing food insecurity in the previous 12 months
  • Attend a primary care or ambulatory visit at BMC's primary care suites

Exclusion Criteria

  • Documentation of housing insecurity
  • Receiving services from the BACO complex care management program

Outcomes

Primary Outcomes

Change in reported food insecurity based on the United States Department of Agriculture (USDA) food insecurity module

Time Frame: Baseline, 6 months

The 6-item USDA food insecurity 30-day lookback module will be collected via interview at baseline and at 6 months

Secondary Outcomes

  • Change in reported fruit and vegetable consumption(Baseline, 6 months)
  • Total number of all-cause inpatient discharges(Baseline, 6 months, 12 months)
  • Total patient-level cost of care(Baseline, 6 months, 12 months)
  • Change in food insecurity status based on THRIVE Screener(Baseline, 12 months)
  • Total number of all-cause emergency department (ED) visits(Baseline, 6 months, 12 months)

Study Sites (1)

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