Community Pharmacy Produce Prescriptions (CP3): Design, Implementation, and Evaluation of a Produce Prescription Program in Community Pharmacies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 610
- 试验地点
- 3
- 主要终点
- Rate of PRx Program Utilization
研究概览
简要总结
The goal of this clinical trial is to generate evidence on the feasibility and effectiveness of community pharmacies as the implementers of a produce prescription program for adults with diabetes and/or hypertension. The main question this study plans to answer is if using community pharmacies as a point-of-service for improving nutrition and health is feasible and effective. The trial also explores the impact of the program on food security, nutrition security, diet quality and health and patient centered outcomes.
Participants will be enrolled in a produce prescription program to purchase healthy foods at the grocery store where they are currently receiving their pharmacy services. Participants will be asked to attend pharmacy visits to collect biometrics at two different time points and complete electronic surveys at three different time points.
详细描述
Produce prescription programs are an increasingly common Food is Medicine (FIM) intervention, with over 100 programs launched in US healthcare systems over the past decade. Mounting evidence from these programs suggests health-related benefits, including reductions in household food insecurity, increased consumption of fruits and vegetables, and improvements in clinical outcomes such as diastolic blood pressure, hemoglobin A1c, and body mass index.
Pharmacies routinely engage in vital screening and referral services, including monitoring blood glucose, blood pressure, cholesterol levels, and administering vaccinations, among other patient care services. However, the community pharmacy setting has remained a largely underutilized and understudied platform for advancing FIM. Historically, FIM interventions have been designed and delivered through hospitals, medical clinics, or community non-profit organizations. The next phase of FIM efforts involves expanding screening and referral for such programs to community pharmacies, including those affiliated or co-located with grocery stores. Community Pharmacy Produce Prescriptions study intervention will be delivered via a Produce Prescription (PRx) electronic benefit card. Each month, participants will receive a fixed amount of funds on the PRx card to purchase fruits, vegetables, beans, nuts, nut butters, seeds, plant-based oils, seafood, and yogurts from participating grocery stores. These funds will be provided after the initial baseline in-person visit is completed. The card will be reloaded monthly for a period of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Age 18 years or older
- •Presence of one or more of the following conditions: type 2 diabetes or hypertension. (Type 2 diabetes and hypertension will be defined by the combination of a self-reported physician diagnosis of one of the conditions and at least one pharmacy prescription for one of the conditions.)
- •Able to converse, and complete the research surveys in English or Spanish, based on self-report.
- •Positive screening for food or nutrition insecurity by:
- •Hunger Vital Sign™ screening and,
- •Nutrition Security Screener
排除标准
- •Unable to provide informed consent.
- •Unable to read and write.
- •Self-reported serious medical conditions that may be expected to shorten life expectancy to less than one year
- •A condition that limits participant's ability to grocery shop or choose food for themselves
- •Plans to move to a new home in the next 6 months that would require use of a different pharmacy
- •Currently pregnant or pregnancy planned within the next 6 months
- •Currently using or planning to start an insulin pump or other automated insulin delivery device within the next 6 months
- •Currently on a GLP-1 agonist or planning to start a GLP-1 agonist within the next 6 months
- •Currently receiving or planning to receive within the next 6 months another Food is Medicine program, like PRx, Grocery Rx, or Medically Tailored Meals
研究组 & 干预措施
Produce Prescription Group
干预措施: Produce Prescription (Other)
Produce Prescription Group
干预措施: Nutrition Education (Behavioral)
结局指标
主要结局
Rate of PRx Program Utilization
时间窗: Up to 6-months
The utilization rate will be calculated by dividing the number of PRx cards redeemed by the total number of PRx cards distributed at each pharmacy.
Rate of PRx Program Redemption
时间窗: Up to 6-months
The redemption rates will be calculated based on the average proportion of dollar amounts redeemed over the total dollar amounts of benefits distributed.
Change in Food Security
时间窗: baseline, 3-months, 6-months
Assessed by the USDA's Household Food Security Survey Module: Six-Item Short Form. The sum of affirmative responses to the six questions is the household's raw score. A raw score of 0-1 indicates food security, while a score of 2-6 indicates food insecurity.
Change in Nutrition Security
时间窗: baseline, 3-months, 6-months
Assessed by the Nutrition Security Screener. Respondents will be classified as nutrition secure if they answer, "Not hard at all" or "Not very hard" to item 1 or nutrition insecure if they answer, "Somewhat hard", "Hard", or "Very Hard."
Change in Diet Quality
时间窗: baseline, 3-months, 6-months
Assessed by a modified Mini-Eating Assessment Tool (EAT). A calculated score will be created such that a higher score is indicative of healthier dietary patterns.
次要结局
- Change in Hemoglobin A1c(baseline and 6-months)
- Change in Continuous Glucose Monitor (CGM) Time-in-range(baseline and 6-months)
- Change in Blood Pressure(baseline and 6-months)
- Change in Body Mass Index(baseline and 6-months)
- Change in Patient Reported Health Related Quality of Life(baseline, 3-months, 6-months)
- Change in Disease Self-management(baseline, 3-months, 6-months)
研究者
Dariush Mozaffarian
Director, Food is Medicine Institute
Tufts University