Fresh Truck Pilot to Reduce Food Insecurity in a Medicaid ACO
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|ClinicalTrials.gov 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Recruitment Status : Withdrawn (The COVID-19 pandemic impacted study methods.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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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|
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
- 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
- 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
- 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
- Total number of all-cause emergency department (ED) visits [ Time Frame: Baseline, 6 months, 12 months ]Collected via BMC HealthNet Plan claims data
- Total number of all-cause inpatient discharges [ Time Frame: Baseline, 6 months, 12 months ]Collected via BMC HealthNet Plan claims data
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT04017624
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Michael Silverstein, MD MPH||Boston Medical Center|