Developing and Testing a Produce Prescription Implementation Blueprint to Improve Food Security in a Clinical Setting

NCT ID: NCT05941403

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-12-31

Brief Summary

The goal of this pilot feasibility implementation trial is to assess preliminary feasibility and acceptability of a set of produce prescription implementation strategies. Produce prescription programs are one approach to addressing food insecurity, or the lack of adequate access to safe and nutritious foods. Produce prescriptions involve healthcare providers identifying patients at risk for food insecurity and writing prescriptions for those patients to receive subsidized vegetables. In this study, the investigators will work with a community advisory board to develop a set of enhanced implementation strategies (e.g., training, technical assistance) to support healthcare providers in delivering produce prescription programs. The investigators will assess the feasibility, acceptability, and appropriateness of these strategies. Pre-post changes in implementation outcomes (i.e., adoption) and effectiveness outcomes (i.e., food security) will be examined.

Detailed Description

Healthcare providers/staff and patients will be recruited from allied Integra health centers. Following enrollment in the already existing produce prescription program ("VeggieRx"), participants will be asked if they would be interested in participating in the research study that entails surveys regarding the program. The investigators expect to recruit participants into the study starting shortly after patients get enrolled in the program. Potential participants will be informed that their decision about whether to participate in the research study will not affect their eligibility or enrollment in the VeggieRx program. They will also be informed that this study seeks to understand strategies to improve the current VeggieRx program. A research assistant will follow-up with interested patients/providers/staff and complete enrollment, consents, and a baseline assessment, either in the waiting room to complete on their own, over the phone or Zoom, OR if they choose to complete it on their own, the study team will send them the link to the consent and survey. It should be noted that participants can either choose to complete the surveys on their own through a survey link (which will be the default) or the surveys can be administered by the study staff. The study team hopes to collect baseline measures before the delivery of their first vegetables which typically begins the second week in July. While providers/staff will not be receiving vegetables, the study team also hopes to collect their baseline data when the program begins (by second week of July). Follow-up data collection for patients will occur after their final delivery (usually end of November) and provider/staff survey will also occur around that time. The study team will communicate with the program to find out when the last deliveries are occurring (not gathering any patient information, just overall timeline).

Baseline and final measures for participating patients are each expected to take approximately 15-20 minutes. In addition, VeggieRx participants will also complete a biweekly measure of engagement which will take approximately 2-minutes each time and will be sent via text message or email depending on participants' preferences throughout the duration of the 6-month VeggieRx delivery period. These questions will ask if they received their vegetable delivery, how much they liked the vegetables, how much they used them and if they fit with their families' eating habits.

As described above, providers and staff will be contacted via email/text/phone by the research assistant asking them to participate. They can complete measures with a research assistant or on their own. Baseline and follow-up surveys for providers/staff are each expected to take 10-20 min. All previously mentioned study procedures can take place in Spanish for patients whose primary language is Spanish by the research assistant research staff that is fluent in Spanish.

Conditions

Food Insecurity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Enhanced Produce Prescription Implementation

The study team will develop an enhanced implementation blueprint to support uptake of the produce prescription (VeggieRx) intervention that is informed by advisory board input and includes multiple implementation strategies to address identified barriers to implementation.

Group Type: EXPERIMENTAL

Enhanced Produce Prescription Implementation

Intervention Type: BEHAVIORAL

Practices make modifications to their usual produce prescription program based on an implementation blueprint. While the exact implementation strategies to be added will be defined based on qualitative data (data collection in progress), possible implementation strategies may include training or technical assistance.

Interventions

Enhanced Produce Prescription Implementation

Practices make modifications to their usual produce prescription program based on an implementation blueprint. While the exact implementation strategies to be added will be defined based on qualitative data (data collection in progress), possible implementation strategies may include training or technical assistance.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• healthcare provider/staff member who makes referrals to produce prescriptions (VeggieRx)
• fluent in English and/or Spanish

• 18 years of age or older
• enrolled in the produce prescription program (VeggieRx)
• fluent in English and/or Spanish

Exclusion Criteria

• under age 18
• have not been involved in referral process for produce prescriptions (VeggieRx)
• are not fluent in English and/or Spanish

• under age 18
• declined to enroll in the produce prescription program (VeggieRx)
• are not fluent in English and/or Spanish

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peter G. Peterson Foundation

UNKNOWN

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hannah E Frank, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Alison Tovar, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown Research on Implementation and Dissemination to Guide Evidence use (BRIDGE) Program

Providence, Rhode Island, United States

Department of Behavioral and Social Sciences/School of Public Health

Providence, Rhode Island, United States

Countries

United States

References

Frank HE, Guzman LE, Ayalasomayajula S, Albanese A, Dunklee B, Harvey M, Bouchard K, Vadiveloo M, Yaroch AL, Scott K, Tovar A. Developing and testing a produce prescription implementation blueprint to improve food security in a clinical setting: a pilot study protocol. Pilot Feasibility Stud. 2024 Mar 23;10(1):51. doi: 10.1186/s40814-024-01467-7.

Reference Type: BACKGROUND

PMID: 38521931 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

008225

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00000018

Identifier Type: -

Identifier Source: org_study_id