Abstract
BACKGROUND: Food insecurity is common in the United States, especially in Rhode Island, where it affects up to 33% of residents. Food insecurity is associated with adverse health outcomes and disproportionally affects people from minoritized backgrounds. Produce prescription programs, in which healthcare providers write "prescriptions" for free or reduced cost vegetables, have been used to address food insecurity and diet-related chronic disease. Although there is growing evidence for the effectiveness of produce prescription programs in improving food security and diet quality, there have been few efforts to use implementation science methods to improve the adoption of these programs. METHODS: This two-phase pilot study will examine determinants and preliminary implementation and effectiveness outcomes for an existing produce prescription program. The existing program is funded by an Accountable Care Organization in Rhode Island and delivered in primary care practices. For the first phase, we conducted a formative evaluation, guided by the Consolidated Framework for Implementation Research 2.0, to assess barriers, facilitators, and existing implementation strategies for the produce prescription program. Responses from the formative evaluation were analyzed using a rapid qualitative analytic approach to yield a summary of existing barriers and facilitators. In the second phase, we presented our formative evaluation findings to a community advisory board consisting of primary care staff, Accountable Care Organization staff, and staff who source and deliver the vegetables. The community advisory board used this information to identify and refine a set of implementation strategies to support the adoption of the program via an implementation blueprint. Guided by the implementation blueprint, we will conduct a single-arm pilot study to assess implementation antecedents (i.e., feasibility, acceptability, appropriateness, implementation climate, implementation readiness), implementation outcomes (i.e., adoption), and preliminary program effectiveness (i.e., food and nutrition security). The first phase is complete, and the second phase is ongoing. DISCUSSION: This study will advance the existing literature on produce prescription programs by formally assessing implementation determinants and developing a tailored set of implementation strategies to address identified barriers. Results from this study will inform a future fully powered hybrid type 3 study that will use the tailored implementation strategies and assess implementation and effectiveness outcomes for a produce prescription program. TRIAL REGISTRATION: Clinical trials: NCT05941403 , Registered June 9, 2023.