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

NCT05941403 | Completed

• 2 other identifiers: STUDY00000018008225
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Food Insecurity

Keywords

food insecurity; implementation science; produce prescription program

Outcome Measures

Primary Outcomes (26)

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores on each item indicate higher engagement. Scores range from 4-20.

  Baseline

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 2

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 4

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 6

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 8

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 10

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 12

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 14

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 16

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 18

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 20

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 22

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 24

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 26

• Patient Engagement with the Produce Prescription Program Questionnaire

  Patient engagement will be measured with a 4-question biweekly questionnaire that includes items rated on a 5-point (1-5) Likert-scale related to whether patients received the produce and whether they used it and liked it. Higher scores indicate higher engagement. Scores range from 4-20.

  Week 28

• Acceptability of Intervention Measure

  Acceptability of produce prescriptions will be assessed using the 4-item Acceptability of Intervention measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher acceptability of the intervention. Scores range from 4-20.

  Baseline

• Acceptability of Intervention Measure

  Acceptability of produce prescriptions will be assessed using the 4-item Acceptability of Intervention measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher acceptability of the intervention. Scores range from 4-20.

  6 month follow up

• Feasibility of Intervention Measure

  Feasibility of produce prescriptions will be assessed using the 4-item Feasibility of Intervention Measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher feasibility of the intervention. Scores range from 4-20.

  Baseline

• Feasibility of Intervention Measure

  Feasibility of produce prescriptions will be assessed using the 4-item Feasibility of Intervention Measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher feasibility of the intervention. Scores range from 4-20.

  6 month follow up

• Intervention Appropriateness Measure

  Appropriateness of produce prescriptions will be assessed using the 4-item Intervention Appropriateness Measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher appropriateness of the intervention. Scores range from 4-20.

  Baseline

• Intervention Appropriateness Measure

  Appropriateness of produce prescriptions will be assessed using the 4-item Intervention Appropriateness Measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicate higher appropriateness of the intervention. Scores range from 4-20.

  6 month follow up

• Evidence-Based Practice Attitudes Scale

  The Evidence-Based Practice Attitudes Scale measures providers' attitudes toward evidence-based practices - specifically produce prescription programs. Scores range from 0 (not at all) to 4 (to a very great extent); higher scores indicate more positive attitudes toward evidence-based practices. Scores are calculated as an average and range from 0-4.

  6-month follow up

• Feasibility of Participant Enrollment

  Proportion of participants who agree to enroll in the study out of those who are enrolled in the produce prescription program

  Baseline

• Implementation Climate Scale

  This measure of implementation climate will assess the innovation-specific organizational climate for implementing produce prescription programs. Responses will be rated on a 4-point scale ranging from 0 (not at all) to 4 (very great extent). Higher responses indicate a stronger implementation climate. Scores are calculated as an average and range from 0-4.

  6 month follow up

• Implementation Readiness: Organizational Readiness for Implementing Change

  This measure will assess organizations' readiness to implement a new intervention. Responses will be rated on a 5 point scale ranging from 1 (disagree) to 5 (agree). Higher scores indicate higher organizational readiness for change. Scores range from 12-60.

  Baseline

• Implementation Readiness: Organizational Readiness for Implementing Change

  This measure will assess organizations' readiness to implement a new intervention. Responses will be rated on a 5 point scale ranging from 1 (disagree) to 5 (agree). Higher scores indicate higher organizational readiness for change. Scores range from 12-60.

  6-month follow up

Secondary Outcomes (9)

• Adoption of Produce Prescriptions

  Baseline

• Adoption of Produce Prescriptions

  6 month follow up

• Effectiveness: Food Security

  Baseline; 6 month follow up

• Effectiveness: Food Security

  Baseline

• Effectiveness: Nutrition security

  6 month follow up

Study Arms (1)

Enhanced Produce Prescription Implementation

EXPERIMENTAL

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.

Behavioral: Enhanced Produce Prescription Implementation

Interventions

Enhanced Produce Prescription Implementation 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.

Enhanced Produce Prescription Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• under age 18
• have not been involved in referral process for produce prescriptions (VeggieRx)
• are not fluent in English and/or Spanish
• years of age or older
• enrolled in the produce prescription program (VeggieRx)
• 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

Sponsors & Collaborators

• Brown University: lead
• Peter G. Peterson Foundation: collaborator

Study Sites (2)

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

Providence, Rhode Island, 02912, United States

Location

Department of Behavioral and Social Sciences/School of Public Health

Providence, Rhode Island, 02912, United States

Location

Related Publications (1)

• 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.

  PMID: 38521931 BACKGROUND

Study Officials

• Hannah E Frank, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

• Alison Tovar, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: July 12, 2023
• Study Start: June 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)