Food InsecurityNCT04017624
Fresh Truck Pilot to Reduce Food Insecurity in a Medicaid ACO
A study testing Fresh Truck with stipend and THRIVE screening and referral in people with Food Insecurity, run by Boston Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity
- What is being tested?
- Fresh Truck with stipend and THRIVE screening and referral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2020to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Documentation of housing insecurity
- Receiving services from the BACO complex care management program
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Food Insecurity
- Being tested
- Fresh Truck with stipend, THRIVE screening and referral
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Truck with stipendOther
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.
THRIVE screening and referralOther
Also called THRIVE-Basic
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.
| Study group | Role | What they receive |
|---|---|---|
| Fresh Truck with stipend | Experimental | Referral to Fresh Truck mobile market Receives: Other: Fresh Truck with stipend |
| THRIVE-Basic | Active comparator | Screening-and-referral usual care model Receives: Other: THRIVE screening and referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reported food insecurity based on the United States Department of Agriculture (USDA) food insecurity module
The 6-item USDA food insecurity 30-day lookback module will be collected via interview at baseline and at 6 months
Measured: Baseline, 6 months
Secondary outcomes (5)
Change in reported fruit and vegetable consumption
A validated Fruit and Vegetable Consumption measure will be collected via interview at baseline and at 6 months
Measured: Baseline, 6 months
Change in food insecurity status based on THRIVE Screener
Measured by the 2 questions relating to food insecurity in the BMC Health System THRIVE Screener
Measured: Baseline, 12 months
Total number of all-cause emergency department (ED) visits
Collected via BMC HealthNet Plan claims data
Measured: Baseline, 6 months, 12 months
Total number of all-cause inpatient discharges
Collected via BMC HealthNet Plan claims data
Measured: Baseline, 6 months, 12 months
Total patient-level cost of care
BMC HealthNet Plan claims data will be used to determine total cost of care
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study startNov 2020 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Silverstein, MD MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017624
- Sponsor's protocol ID
- H-38756
- Status last verified
- Nov 2020
- First submitted
- 10 Jul 2019
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04017624
- Acronym / sponsor ID
- H-38756
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh Truck with stipend | Experimental | Other: Fresh Truck with stipendReferral to Fresh Truck mobile market |
| THRIVE-Basic | Active comparator | Other: THRIVE screening and referralScreening-and-referral usual care model |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Documentation of housing insecurity
- Receiving services from the BACO complex care management program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh Truck with stipendLinkage 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. | Other | Fresh Truck with stipend |
| THRIVE screening and referralAlso: THRIVE-BasicThe 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 | THRIVE-Basic |
Primary outcome
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
5 secondary outcomes
Change in reported fruit and vegetable consumption
Time frame: Baseline, 6 months
Change in food insecurity status based on THRIVE Screener
Time frame: Baseline, 12 months
Total number of all-cause emergency department (ED) visits
Time frame: Baseline, 6 months, 12 months
Total number of all-cause inpatient discharges
Time frame: Baseline, 6 months, 12 months
Total patient-level cost of care
Time frame: Baseline, 6 months, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Silverstein, MD MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh Truck with stipend and THRIVE screening and referral in people with Food Insecurity, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reported food insecurity based on the United States Department of Agriculture (USDA) food insecurity module (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.