Penn State ProduceRx Feasibility Study
Condition: Dietary Modification
Study type: Observational

Summary: 
      To provide "prescriptions" for weekly Community Supported Agriculture (CSA) boxes of fruits
      and vegetables to patients, accompanied by nutritional education (e.g. printed newsletters
      and YouTube videos), and evaluate benefits for participants by exploring commitment to the
      program, opinions about healthy eating, retention of nutrition and food preparation
      knowledge, overall takeaway from the program, as well as self-assessment of health status.

      To establish the overall feasibility of an effective "prescription produce" program for
      at-risk and underserved patients - called "ProduceRx" - by utilizing produce from regional
      farms in addition to the resources of the Penn State Health System and an interdisciplinary
      team of healthcare workers (dietitians, dietetic interns, and medical students).

      To provide a proof-of-concept for this model (i.e. ProduceRx + interdisciplinary approach to
      health education) for other healthcare institutions.
    

Detailed description: 
      Participating prescribers within the Penn State Health system will identify potential
      patients for ProduceRx based on the "high-risk" or "underserved" requirements. For the
      initial pilot starting on August 1, 2016, the following four physicians have agreed to
      participate with the program/study: Dr. Ann Rogers, Dr. Marsha Novick, Dr. Peter Lewis, and
      Dr. Laurie Nelson, whose specialties are general surgery and minimally invasive bariatric
      surgery, adolescent and bariatric medicine, family medicine, and internal medicine,
      respectively. Additionally, Lisa Hardy, a nurse practitioner at Dr. Ann Rogers' bariatric
      clinic, and Christine Bruce, a physician assistant at Dr. Laurie Nelson's internal medicine
      clinic will serve as the fifth and sixth prescribers. Prescribers will be provided with
      ProduceRx prescription pads that they will use to write "prescriptions" for their patients to
      the program. The prescription pads will be coded with a unique identifying code at the bottom
      that will allow researchers to keep track of data associated with that prescription (i.e.
      patient compliance with the program, difference in patient outcomes with different providers,
      etc.).

      Patients will be recruited by the abovementioned physicians based on the physicians'
      interpretation of the two qualifications for the program: "high-risk" or "underserved."
      Recruiting materials such as informational brochures and advertisement signs (both electronic
      and printed) will be utilized to help these providers explain the program to qualifying
      patients without sacrificing time in the office. If selected patients elect to participate in
      the program, they will visit the ProduceRx website at https://sites.psu.edu/producerx and
      register for the program. Initial registration will feature an informed consent form to
      participate in research associated with this program. Patients will have the option of
      consenting or declining to consent to participation in this research. For those that consent,
      they will complete their initial survey through REDCap before bring routed to the
      participating farm's weekly ordering platform. Those patients who decline to consent will be
      automatically routed to the participating farm's ordering platform to order their first
      weekly box.

      The survey will be a modified version of the CDC's Behavioral Risk Factor Surveillance System
      Questionnaire (BRFSS). This survey will assess patients' demographic characteristics, as well
      as health characteristics and behaviors. Demographic variables include age, race/ethnicity,
      education level, and employment status. Health characteristics include self-reported medical
      conditions, and height and weight (for calculation of body mass index). The survey will ask
      participants to self-report fruit and vegetable consumption and perceived barriers to
      consumption. Level of physical activity will also be monitored throughout the program to see
      if it is affected by changes in nutrition. Additionally, investigators will measure
      compliance of patients with the program; compliance will be defined as the number of weeks
      that patients voluntarily participate (purchase weekly boxes of produce) throughout the
      program from the time that they register with the program until the end of the pilot in
      December 2016.

      During subsequent weeks, patients will visit the farm's website directly to order their
      weekly produce boxes. Participants will be asked to complete a post-program questionnaire at
      the end of the pilot in December 2016. Meanwhile, the main ProduceRx website will function as
      a platform for nutritional education delivery (delivered by medical students, registered
      dietitians, dietetic interns, as well as opportunities for other healthcare workers and
      community members), with links to the program's YouTube cooking/nutrition videos and postings
      of electronic versions of the printed newsletters. The website will also feature a calendar
      of upcoming local events, such as nature hikes, outdoor walks, free cooking classes, and
      farmers' markets, in order to facilitate an overall healthy lifestyle outside of the actual
      program. Additionally, the website will feature a comments section for participants to ask
      questions and communicate with one another. This comments section will be monitored to ensure
      appropriate commenting.

      At the end of the program, a focus group will be held at Penn State Hershey Medical Center
      (PSHMC) to evaluate the functionality/feasibility of the pilot, including logistical
      convenience, how much produce was utilized each week, and what challenges participants faced
      integrating the produce and educational content into their daily lives. The focus group will
      ideally last from 45 to 90 minutes and will be moderated by Sarayna Schock, an MSII and PI on
      this study. A semi-structured interview guide will be used and responses will be recorded to
      adequately capture all feedback. These focus group responses will be recorded and transcribed
      by research volunteers and analyzed by an interdisciplinary research team to identify
      emergent themes.

      To ease the burden of time constraints already imposed on physicians, participating
      healthcare providers will be surveyed via email at the end of the pilot to evaluate their
      perceived program efficacy, the benefit of the program to their patients, and elicit program
      feedback. A semi-structured survey created with REDCap will be used to solicit specific
      responses, in addition to open feedback.
    

Intervention name(s): Produce boxes with nutritional education
Intervention type(s): Behavioral
Intervention description(s): CSA produce boxes "prescribed" to study participants with free online nutritional education included
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients determined to be "underserved" or "at-risk" within the Penn State Health System
      
Keywords: Prevention; Nutrition