Performing Department
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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
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Research Effort Categories
Basic
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Applied
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Developmental
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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.