Clinical trial NCT04017624: Fresh Truck Pilot to Reduce Food Insecurity in a Medicaid ACO
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Food Insecurity
Keywords: Mobile produce market
Boston Accountable Care Organization (BACO)
Medicaid ACO
Accountable Care Organization
ACO
Social determinants of health
THRIVE
Healthcare utilization
Cost of care
Fruit and vegetable consumption
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Change in reported food insecurity based on the United States Department of Agriculture (USDA) food insecurity module
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in reported fruit and vegetable consumption
timeFrame: Baseline, 6 months
measure: Change in food insecurity status based on THRIVE Screener
timeFrame: Baseline, 12 months
measure: Total number of all-cause emergency department (ED) visits
timeFrame: Baseline, 6 months, 12 months
measure: Total number of all-cause inpatient discharges
timeFrame: Baseline, 6 months, 12 months
measure: Total patient-level cost of care
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Michael Silverstein, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: