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Fresh Truck Pilot to Reduce Food Insecurity in a Medicaid ACO

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04017624
Recruitment Status : Withdrawn (The COVID-19 pandemic impacted study methods. Therefore, the study team opted not to conduct this study as written. The study never started and no participants were enrolled.)
First Posted : July 12, 2019
Last Update Posted : November 17, 2020
Information provided by (Responsible Party):
Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
Food Insecurity Other: Fresh Truck with stipend Other: THRIVE screening and referral Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicaid

Arm Intervention/treatment
Experimental: Fresh Truck with stipend
Referral to Fresh Truck mobile market
Other: Fresh Truck with stipend

Linkage to Community Partner Organization

Investigators will partner with a community organization, Fresh Truck, that deploys mobile fresh produce trucks throughout Boston neighborhoods. Participants randomized to the intervention arm will receive a monthly stipend of $80 to purchase fresh produce available at any Fresh Truck mobile market location.

Active Comparator: THRIVE-Basic
Screening-and-referral usual care model
Other: THRIVE screening and referral
The THRIVE screening tool includes questions to identify eight potentially unmet health-related social needs associated with health outcomes and healthcare utilization: housing and food insecurity, inability to afford medications, need for transportation, trouble paying for heat and electricity, need for employment or education, and difficulty taking care of children or other family members. The survey is written at a 3rd grade reading level, is available in multiple languages, and requires less than five minutes to complete. The paper screener consists of two parts: part one screens patients for health-related social needs in the eight domains. Part two asks patients to indicate the resources they want help accessing across the eight domains. Patients who request resources in one or more domains receive paper guides that describe available hospital and community resources to address the specific domain(s) indicated.
Other Name: THRIVE-Basic

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in reported fruit and vegetable consumption [ Time Frame: Baseline, 6 months ]
    A validated Fruit and Vegetable Consumption measure will be collected via interview at baseline and at 6 months

  2. Change in food insecurity status based on THRIVE Screener [ Time Frame: Baseline, 12 months ]
    Measured by the 2 questions relating to food insecurity in the BMC Health System THRIVE Screener

  3. Total number of all-cause emergency department (ED) visits [ Time Frame: Baseline, 6 months, 12 months ]
    Collected via BMC HealthNet Plan claims data

  4. Total number of all-cause inpatient discharges [ Time Frame: Baseline, 6 months, 12 months ]
    Collected via BMC HealthNet Plan claims data

  5. Total patient-level cost of care [ Time Frame: Baseline, 6 months, 12 months ]
    BMC HealthNet Plan claims data will be used to determine total cost of care

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04017624

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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
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Principal Investigator: Michael Silverstein, MD MPH Boston Medical Center
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Responsible Party: Boston Medical Center Identifier: NCT04017624    
Other Study ID Numbers: H-38756
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
Mobile produce market
Boston Accountable Care Organization (BACO)
Medicaid ACO
Accountable Care Organization
Social determinants of health
Healthcare utilization
Cost of care
Fruit and vegetable consumption
Additional relevant MeSH terms:
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Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action