Source: GRIFFIN HOSPITAL, THE submitted to
A PRESCRIPTION FOR HEALTH EQUITY: A HEALTHCARE PROVIDER-BASED PRODUCE PRESCRIPTION PROGRAM FOR PEOPLE WITH PRE-DIABETES AND TYPE 2 DIABETES
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
ACTIVE
Funding Source
Reporting Frequency
Annual
Accession No.
1029440
Grant No.
2022-70424-38552
Cumulative Award Amt.
$500,000.00
Proposal No.
2022-07019
Multistate No.
(N/A)
Project Start Date
Sep 15, 2022
Project End Date
Sep 14, 2025
Grant Year
2022
Program Code
[PPR]- Produce Prescription
Project Director
Comerford, B. P.
Recipient Organization
GRIFFIN HOSPITAL, THE
130 DIVISION ST
DERBY,CT 06418
Performing Department
(N/A)
Non Technical Summary
The project,APrescription for Health Equity: A Healthcare Provider-Based Produce Prescription Program for People with Pre-diabetes and Type 2 diabetes, is a community co-designed, healthcare provider-based PPR program intended to improve participants' diet quality,food security, cardio-metabolic risk factors, and to reduce healthcare costs, specifically related to medication use and hospital visits. Novel to this study is implementation of a randomized controlled trial (RCT) with delayed intervention control group focused on equity in design, implementation, and evaluation. Eligibility includes: patients of Griffin Hospital or Griffin Faculty Practice, pre-diabetes or type 2 diabetes, and Medicaid and/or SNAP eligible. The intervention will last 6-months and consist of nutrition education and produce prescription vouchers adjusted per household size.The project will be conducted in Phases: 1) formative research and co-design with community members through listening sessions and community advisory group sessions to finalize the intervention protocol; 2) the delayed intervention RCT produce prescription program implementation with key data collection at 0, 6 and 9 months; and 3) data analysis and final reporting. The study will evaluate the program's impact on HbA1C, blood pressure, triglycerides, weight, food security status, diet quality, health related quality of life, medication use and hospitalization. All outcomes will be analyzed by race/ethnicity for equity. This project makes significant contributions to the field, particularlyemploying an RCT design and with its focus on health equity.
Animal Health Component
100%
Research Effort Categories
Basic
0%
Applied
100%
Developmental
0%
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
72424201010100%
Knowledge Area
724 - Healthy Lifestyle;

Subject Of Investigation
2420 - Noncrop plant research;

Field Of Science
1010 - Nutrition and metabolism;
Goals / Objectives
The goal of this project is to co-design a healthcare provider-based PPR program with the community served to improve participants' food security status, diet quality, cardio-metabolic health outcomes, and to reduce healthcare costs, specifically related to medication use and hospital visits. As a foundational component, the project design, implementation, and outcomes assessment will focus on equity. Novel to this study is an implementation of a community co-designed RCT with delayed intervention control group focused on equity in design, implementation, and evaluation. The project will be conducted in 3 Phases (See Specific Aims; Project Timeline). Phase I involves formative research and co-design with community partners and potential participants through listening sessions, partner meetings, and community advisory group sessions to finalize the intervention protocol/components, and obtaining IRB approval. The delayed intervention RCT produce prescription program will be implemented in Phase II, with data analysis and final reporting conducted in Phase III.Specific Aims: 1. In collaboration with community partners and community members, utilize implementation science strategies to identify and address community, systemic, and structural barriers and assets to co-design a tailored produce prescription intervention that emphasizes health equity in a low-income population served by GH or GFP. Hypothesis: Collaborating with our community partners on the design and implementation of our program will lead to a successful design and implementation of our produce prescription program to our population of focus as evidenced by satisfaction, retention, experiences of dignity/respect, improved self-efficacy related to fruit and vegetable consumption, and diet quality.2. Demonstrate improvements, in intervention group vs delayed intervention control group, in food security status, diet quality, and cardio-metabolic outcomes in individuals with prediabetes or type 2 diabetes through implementation of a tailored produce prescription programin a low-income population served by GH or GFP.Hypothesis: The produce prescription program designed with community input will improve food security status, diet quality, self-reported health related quality of life and cardio-metabolic outcomes (HbA1C, weight/BMI, lipids, blood pressure), among our intervention participants compared with a control over a 6-month period.3. To evaluate the impact of a produce prescription program on healthcare cost among low-income participants with prediabetes or type 2 diabetes Hypothesis: The successful implementation of the produce prescription program will lead to a reduction in certain healthcare cost specifically related to medication usage (including dose) and reduction in emergency department visit and/or hospitalization among intervention participants compared with a control over a 6-month period.
Project Methods
The proposed delayed intervention control study will utilize qualitative and quantitative methods to assess the process of community co-design, program implementation and the impact of the delivery of a produce prescription program intervention among patients of GH or GFP with prediabetes or type 2 diabetes who are eligible for SNAP or Medicaid. Below is a description of our evaluation plan; as noted, the research team is committed to collecting any additional data as required by NTAE. Evaluation of Activity 1: The formative research will employ qualitative methods to assess the community needs, identify barriers and facilitators, and assess the acceptability of a produce prescription program intervention among those with prediabetes and type 2 diabetes. This formative research will focus on addressing acceptability, uptake, retention, efficacy, and experiences of respect in our community while delivering the produce prescription program. Based on the feedback and lessons learned from the formative research, the strategies for delivering our intervention will then be tailored jointly by the investigators and community partners. We will utilize a Program Impact Pathway (PIP), an implementation science framework, as a tool to increase participant engagement, ownership of the process, and to ensure a comprehensive approach to co-design. The PIP will also detail intervention processes for dissemination and replication. The listening sessions and partner meetings will be recorded and notes will be taken. Sessions will be transcribed and participants deidentified. These data will be analyzed using a rapid analysis technique to support the co-design phase. The rapid analysis technique, used in prior studies, will include two coders for each session. Results will be discussed with the team and reported to partners and participants for confirmation prior to finalizing. These results will be provided in report form and will guide adaptations to the PIP. An iterative approach to refining the PIP will be utilized, informed by these meetings.Evaluation of Activities 2 & 3: The delayed intervention control trial will assess the impacts of our intervention on diet quality, food security, and cardio-metabolic risk factors through a survey and biometric measures. Data collection will occur at 0 months/baseline, 3 months (survey measures only) , 6 months, and 9 months. At baseline, 6- and 9-months participants will complete a survey and provide biometric measures. An appointment will be scheduled at which trained study staff will collect biometrics (HbA1c, blood pressure, serum lipids, weight (and height at baseline only)) and participants will complete all surveys. At 3 months, participants in the intervention group will receive a link to a short survey in Qualtrics via text message to assess engagement and adherence. Quantitative data related to intervention processes as well as engagement will be monitored through an activities log collected by the study coordinators. Similarly, qualitative data will be collected throughout the study using a field note form. Field notes will include major news and events that may affect study outcomes, e.g. supply chain shortages effecting availability at grocery stores or rising COVID rates, these notes will allow for collection of contextual qualitative data and anecdotes that may be relevant to understanding and interpreting the data later. Short open-ended survey items will be thematically coded by at least 2 coders to identify themes in the data. The preliminary logic model (see Figure 1: Appendix ) will be modified based on input from community partners and key stakeholders during the formative research phase and used to execute and evaluate our implementation process, with revisions made prior to translation and dissemination. Lastly, as part of our plan to develop and evaluate our program guided by principles of racial equity, data will be analyzed by race and ethnicity, assessing equity in retention, engagement, and outcomes.Assessing impact: Linear mixed model regressions with time as repeated measure will be used to assess the impact of our interventions over time, comparing the pre-post outcome scores in the intervention with the pre-post scores in the control participants. Paired t-test will be used to assess changes from baseline. In addition to the effect of time on the outcome measures, other factors will be incorporated into the regression models to adjust for baseline food insecurity, baseline diet quality, and program engagement level. Differences by group for medication change, ED, and hospital visits will also be assessed. Distributions of variables are expected to meet criteria for analysis with parametric statistics, but distributions will be assessed prior to analyses. As indicated, log transformation of data or nonparametric analytic techniques will be employed. In all analyses, a two-tailed alpha of less than 0.05 will be considered statistically significant. SAS software for Windows version 9.4 (SAS Institute, Cary, NC) will be used to carry out all statistical analyses.

Progress 09/15/23 to 09/14/24

Outputs
Target Audience:Our target audience includes: adultpatients of Griffin Hospital and Griffin Faculty Physicians with a diagnosis of Prediabetes or Type 2 Diabetes who are considered low income as derternimed by medicaid elegibility. Patients meeting the studyinclusion criteria were identified through a search of the medical record database.Recruitment methodsincluded a series oflettersmailed to eligible patients of Griffin Faculty Physicians (GFP), as well as direct contact by the GFP Diabetes Educator to refer patients to the study. This recruitment effort initially included two GFP practices,one primary care and one endocinology,in Ansonia, CT as those were identified with the largest number of patients meeting study eligibility, and was later extended to 3 additional practices in neighoring towns (Oxford, Southbury and Naugatuck) to meet our enrollment target. This project is intended to benefit Connecticut residents who are low income and reside within Griffin Hospital's primary service area (i.e., the Lower Naugatuck Valleycommunities) through improved access to healthy nutritious foods, reduced food insecurity, diabetes risk reduction/diabetes management and related reduction of cardiovascular disease risk, as well as reduction in medication and hospital visits. Changes/Problems:There have not been any major changes or problems encountered during this period. Issues that participants reported during the monthly check-in calls were relatively routine and expected and wereaddressed as described in the "Accomplishments" section of this report. The only issue that was unexpected was the reported planned closure of the Stop 'n Shop grocery store located in Ansonia, CT as that was the store that wasusedmost often by participants. The project team met to explore the potential impact of that store closure when it was announced late summer (projected close date of 10/24) and a plan was developed to address the situation proactively. That plan included reaching out to our project officer and client services at About Fresh/Fresh Connect to determine whether the Shop Rite store in Ansonia could be onboarded to the Fresh Connect platform to expand store ooptions. Unfortunatetly, the Wakefern/Shop Rite company is more than one year behind in their initial plan to join the Fresh Conenct platform so that did not turn out to be a viable solution. We will continue to assess store and incentive card utilization and address issues if/as they arise. We feel this has had a significant positive impact and influence on participants. What opportunities for training and professional development has the project provided?The project director has found the annual grantee meetings very helpful in leanring more about the range of nutrition incentive programs available and how they operate, as well as the opportunity to network and share resources amongst the GusNIP grantees. How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals?During Year Three, we will continue to conduct the monthly check-in calls toaddress anyissues orconcerns of study participants, and continue to encourage uptake of the nutrition education offerings through the monthly E-Newsletters. The procedures we put in place to monitor and follow-up on incnentive utilzationwill continue throughout the intervention period. We will perform data cleaning and conduct interim data analyses as participants complete the various assessment time points (baseline, 6 and 9 months) in preparation for the final analysis and reporting to meet the grant deadline. We will identify opportunities to disseminate products, such aspresentations, manuscripts, etc. resuting from this project.

Impacts
What was accomplished under these goals? The Specific Aim #1 was accomplished in Year One of this project. The co-design process, which included listening sessions with eligible participants and meetings with our community advisory group (composed of CBOs and stakeholders)informed the final intervention components, specifically the type of incentive (Fresh Connect card) and preferences for nutritioneducation offered. All data collection instruments were finalized in preparation for recruitment and enrollment activities in Year Two. In Year Two, efforts were focused on meeting Specific Aims 2 and 3. During this period, we screened 200 patients by phone to determine elgibility.Of those, 146 met the eligibility criteria and54 were determined to be ineligble or were not interested in enrolling; Between October 2023 and September 2024we enrolled 131 participants and closed enrollment in order to meet the granttimeline. Participants were randomly assigned to the intervention or control (delayed intervention) groups. Participants in the intervention group receivethe Fresh Connect incentive card for a duration of 6 months and complete required assessments (below), while participants assigned to the control (delayed intervention) group completethe assessments (baseline, 6 and 9 months) and recevie the Fresh Connect incentive card following their 9 months assessment. Participants in the control (delayed intervention) group began receiving the Fresh Connect incentive card beginning in August 2024. During the intervention period, participants complete surveys assessing food security status, diet quality, and self-reported health-related quality of life, and a medication log, and undergo biometric assessments measuring HbA1c, weight/BMI, lipids, and blood pressure at baseline, 6 and 9 months. Participants in the intervention group also complete a satisfaction survey at 3 months. The following was included to support the program's objectives: A nutrition handbook was provided during the enrollment process, which includes a cookbook, a nutrition information guide from reputable websites, and printouts of monthly newsletters. A monthly email newsletter was sent that included produce preparation tips, recipe links, nutrition education class details, and reminders to utilize card balances In-person and Zoom nutrition education classes (SNAP-Ed) were offered Six one-on-one telephone coaching sessions with a dietitian (SNAP-Ed) were offered Monthly check-in calls to encourage the use of incentives and address any participant concerns were conducted Throughout Year Two, our project team met bi-weekly to review/discuss recruitment and enrollment activitiy to inform any necessary changes to meet our goals (e.g., expanding our reach to include 3 additional offices, etc.). Additionally, our project team heldmonthly meetings to review the Fresh Connect card utilization among participants.As part of our ongoing support, we conducted check-in calls with all participants in the intervention group, prioritizing those who didnot used their full monthly incentive amount. During these calls, our objecitive wasto understand any barriers to utilization, troubleshoot andaddress any concerns or issues, and help as needed to ensure participants benefit fully from the program. Many participants have expressed their gratitude for these reminder calls as they served not only as a reminder to use the full card amount by the end of the month, but also provided an opportunity for information to be shared/questiones to be answered. The barriers or issues participants reported included limited grocery store options (namely only Stop 'n Shop and Walmart) in the local area, with a noted preference for Shop Rite and Aldi, transportation, and change in card replacement procedures where participants now have to call Fresh Connect directly to request a card replacement. This new process has been challenging for some, so a member of our project team has assisted participants by facilitating three-way calls to help guide them through the process. Although the transporation issue affected only a very small number of participants to date, we were able to address that by arranging rides, via Lift, for participants to attend their periodic follow-up visits for assessments. Transportation to the grocery stores did not seem to be an issue. Additionally, we have connected participants with social needs to the Griffin Hospital Community Health Worker (CHW) who is a member of our proejct team, for further support as needed. Overall, a review of participant incentive card utilizationto daterevealed a high average utilzation rate (of total dollars spent) of nearly 86%. That includes 3 outliers that did not use the incentives for the majority of the intervnetion period, so the average utilization is actually higher.

Publications


    Progress 09/15/22 to 09/14/23

    Outputs
    Target Audience:Population of interest: Prediabetic and type 2 diabetic patients Initially, recruitment letters were sent to patients with type 2 diabetes who are part of Griffin Faculty Physicians (GFP). This recruitment effort specifically targeted two GFP offices, namely Ansonia and the Endocrinologists Practice. Patients meeting the study's inclusion criteria were identified through a thorough search of medical records. The subsequent round of mailings will be directed towards patients who have been identified as having prediabetes. Breakdown of recrutment to date Number of patients phone screened to date:58 Number of patients eligible for enrollment: 32 Ineligible for enrollment: 12 Eligibility screening pending: 14 Changes/Problems:Finding the right gift card provider presented significant challenges. During the community listening sessions with potential participants, it became clear that ShopRite was the preferred grocery store. However, we encountered obstacles in obtaining produce-restricted vouchers or gift cards, and we couldn't locate a vendor that partnered with Wakefern, ShopRite's parent company. We made every effort to address the feedback from the listening sessions comprehensively, but unfortunately, we couldn't fulfill this specific request. We have communicated this limitation to the participants in the listening sessions to ensure transparency. As a solution, the research team has selected a card provider that allows participants to shop at Super Walmart or Stop and Shop. It's possible that this vendor may become compatible with ShopRite before the intervention concludes, but this is yet to be determined. The chosen vendor is About Fresh, and their card is known as Fresh Connect. What opportunities for training and professional development has the project provided? Nothing Reported How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

    Impacts
    What was accomplished under these goals? Specific aim #1 was achieved.The research team invited key commuity partners to be part of a co-design working group to provide guidance on the successful implementation of the project. The key commuity partners include; Massaro Farm Griffin Health Services- Dining Services Griffin Health Services-Population Health Division TEAM, Inc Naugatuck Valley Health District Valley Community Foundation CT Department of Social Services (DSS) Y-G PRCCommunity Advisory Group (CAG) Griffin Hospital Patient & Family Advisory Council (PFAC) Community Residents (meeting eligibility criteria) The research team held 5 listening sessionswith 15 community residents (meeting eligibility criteria) to provide input on recruitment, giftcard redemption, nutrition education and health equity. Specific aims 2 and 3 are still in progress because the intervention has not yet started.

    Publications