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临床试验/NCT04017624
NCT04017624撤回不适用

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 Center2 个研究点 分布在 1 个国家开始时间: 2020年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in reported food insecurity based on the United States Department of Agriculture (USDA) food insecurity module

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: Baseline, 6 months

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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