Clinical trial NCT05941403: Developing and Testing a Produce Prescription Implementation Blueprint to Improve Food Security in a Clinical Setting
Official title: Developing and Testing a Produce Prescription Implementation Blueprint to Improve Food Security in a Clinical Setting: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Keywords: food insecurity
implementation science
produce prescription program
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Peter G. Peterson Foundation
First posted: 2023-07-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Healthcare providers/staff 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

Healthcare providers/staff Exclusion Criteria

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

Patient Inclusion Criteria:

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

Patient Exclusion Criteria:

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

Primary outcomes:
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Baseline
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 2
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 4
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 6
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 8
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 10
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 12
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 14
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 16
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 18
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 20
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 22
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 24
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 26
measure: Patient Engagement with the Produce Prescription Program Questionnaire
timeFrame: Week 28
measure: Acceptability of Intervention Measure
timeFrame: Baseline
measure: Acceptability of Intervention Measure
timeFrame: 6 month follow up
measure: Feasibility of Intervention Measure
timeFrame: Baseline
measure: Feasibility of Intervention Measure
timeFrame: 6 month follow up
measure: Intervention Appropriateness Measure
timeFrame: Baseline
measure: Intervention Appropriateness Measure
timeFrame: 6 month follow up
measure: Evidence-Based Practice Attitudes Scale
timeFrame: 6-month follow up
measure: Feasibility of Participant Enrollment
timeFrame: Baseline
measure: Implementation Climate Scale
timeFrame: 6 month follow up
measure: Implementation Readiness: Organizational Readiness for Implementing Change
timeFrame: Baseline
measure: Implementation Readiness: Organizational Readiness for Implementing Change
timeFrame: 6-month follow up
Secondary outcomes:
measure: Adoption of Produce Prescriptions
timeFrame: Baseline
measure: Adoption of Produce Prescriptions
timeFrame: 6 month follow up
measure: Effectiveness: Food Security
timeFrame: Baseline; 6 month follow up
measure: Effectiveness: Food Security
timeFrame: Baseline
measure: Effectiveness: Nutrition security
timeFrame: 6 month follow up
measure: Effectiveness: Patient Health Questionnaire-2
timeFrame: baseline, 6-month follow up
measure: Effectiveness: Patient Health Questionnaire-2
timeFrame: 6-month follow up
measure: Effectiveness: Dietary Screener Guide
timeFrame: baseline, 6-month follow up
measure: Effectiveness: Dietary Screener Guide
timeFrame: 6-month follow up
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown Research on Implementation and Dissemination to Guide Evidence use (BRIDGE) Program
state: Rhode Island
city: Providence
country: United States
facility: Department of Behavioral and Social Sciences/School of Public Health
state: Rhode Island
Study officials:
affiliation: Brown University
name: Hannah E Frank, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Alison Tovar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.