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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
610
Each month, participants will receive a fixed amount of funds on the PRx card. Participants will be able to use these funds to purchase fruits, vegetables, beans, nuts, nut butters, seeds, plant-based oils, seafood, and yogurts from participating grocery stores. These funds will be provided through an electronic PRx benefit card that is activated after the initial baseline in-person visit is completed. The card will be reloaded monthly for a period of 6 months.
Participating pharmacies/grocery chains will have Registered Dietitians (RD/RDN) on staff who can provide participants with nutrition education programs, coaching, and/or nudges.
Rate of PRx Program Utilization
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.
Time frame: Up to 6-months
Rate of PRx Program Redemption
The redemption rates will be calculated based on the average proportion of dollar amounts redeemed over the total dollar amounts of benefits distributed.
Time frame: Up to 6-months
Change in Food Security
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.
Time frame: baseline, 3-months, 6-months
Change in Nutrition Security
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."
Time frame: baseline, 3-months, 6-months
Change in Diet Quality
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.
Time frame: baseline, 3-months, 6-months
Change in Hemoglobin A1c
For participants with diabetes, pharmacy staff will conduct a point-of-care hemoglobin A1c measurement of blood obtained by fingerstick.
Time frame: baseline and 6-months
Change in Continuous Glucose Monitor (CGM) Time-in-range
Time-in-range is the percentage of time spent with glucose levels in the target range. For participants with diabetes, pharmacy staff place a CGM, per product instructions, on the participant with a goal to wear for 10 days (each time).
Time frame: baseline and 6-months
Change in Blood Pressure
Pharmacy staff will measure participants' systolic and diastolic blood pressure.
Time frame: baseline and 6-months
Change in Body Mass Index
Pharmacy staff will collect height and weight.
Time frame: baseline and 6-months
Change in Patient Reported Health Related Quality of Life
Assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health, the scoring system converts responses from a 10-item questionnaire into T-scores for Global Physical Health (GPH) and Global Mental Health (GMH), where higher scores indicate better health.
Time frame: baseline, 3-months, 6-months
Change in Disease Self-management
Assessed by the 6-item Self Efficacy for Managing Chronic Disease (SEMCD) scale. Scores will be calculated as the mean response to the six questions. A higher score is indicative of higher self-efficacy.
Time frame: baseline, 3-months, 6-months
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