Penn State ProduceRx Feasibility Study

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.

Inclusion Criteria:

1. Individuals (ages 18-75) who are currently patients in the Penn State Hershey Health
system in the departments of Family and Community Medicine, General Pediatrics,
Internal Medicine, General Surgery and Minimally Invasive Surgery/Bariatric,
Endocrinology, and Cardiology.

2. Individuals at risk for developing chronic illness and metabolic disease as
identified by PCP, care coordinator, or a participating physician from an
abovementioned specialty.

3. Individuals willing to participate in the program and complete a pre-program survey
and a post-program survey in December 2016.

4. Individuals with access to transportation to and from the CSA drop-off sites.

5. Individuals willing/able to pay the $10 subsidized "copay" for the weekly box of
produce (federal food stamps in the form of SNAP/EBT vouchers will be accepted by
Strites Orchard as a means of payment).

6. Individuals that speak English.

7. Individuals with difficulty obtaining fresh produce or lack of knowledge regarding
healthy cooking methods and nutrition, as determined by PCP or a participating
physician from an abovementioned specialty.

8. Prescribers (physicians, nurse practitioners, and physician assistants) in the Penn
State Hershey Health system in the departments of Family and Community Medicine,
General Pediatrics, Internal Medicine, General Surgery and Minimally Invasive
Surgery/Bariatric, Endocrinology, and Cardiology.

Exclusion Criteria:

1. Individuals outside of immediate areas of Strites Orchard's CSA drop-off sites (which
include the following: Bosler Avenue, Lemoyne; Koch Lane Harrisburg (Paxtonia);
Allendale, Camp Hill; Strites Orchard, Harrisburg; Dogwood Lane, Dillsburg; East
Willow Street, Elizabethtown; Hampden Summit; Linglestown Rd., Harrisburg; St. Johns
Drive, Camp Hill; Shetland Dr., Hummelstown; West Areba Ave., Hershey; Wickerberry
Lane, Palmyra; W. Green St., Mechanicsburg; Brisban St. Harrisburg (Paxtang); Cattell
St., Middletown; and N. 2nd St., Harrisburg.)

2. Individuals unaffiliated with the Penn State Hershey Health System.

3. Individuals who already have sufficient fruits and vegetables in their diet as
determined by the participating physician.

4. Non-English speaking participants.