Community Pharmacy Produce Prescriptions

Official title

Community Pharmacy Produce Prescriptions (CP3): Design, Implementation, and Evaluation of a Produce Prescription Program in Community Pharmacies

Overview

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.

Detailed description

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.

Interventions

• Other Produce Prescription
  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.
• Behavioral Nutrition Education
  Participating pharmacies/grocery chains will have Registered Dietitians (RD/RDN) on staff who can provide participants with nutrition education programs, coaching, and/or nudges.

Primary outcome measures

• Rate of PRx Program Utilization [Time frame: Up to 6-months]
• Rate of PRx Program Redemption [Time frame: Up to 6-months]
• Change in Food Security [Time frame: baseline, 3-months, 6-months]
• Change in Nutrition Security [Time frame: baseline, 3-months, 6-months]
• Change in Diet Quality [Time frame: baseline, 3-months, 6-months]

Secondary outcome measures (6)

• Change in Hemoglobin A1c [Time frame: baseline and 6-months]
• Change in Continuous Glucose Monitor (CGM) Time-in-range [Time frame: baseline and 6-months]
• Change in Blood Pressure [Time frame: baseline and 6-months]
• Change in Body Mass Index [Time frame: baseline and 6-months]
• Change in Patient Reported Health Related Quality of Life [Time frame: baseline, 3-months, 6-months]
• Change in Disease Self-management [Time frame: baseline, 3-months, 6-months]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06920355 · STUDY00005176

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗