Frank Hannah E, Guzman Linda E, Ayalasomayajula Shivani, Albanese Ariana, Dunklee Brady, Harvey Matthew, Bouchard Kelly, Vadiveloo Maya, Yaroch Amy L, Scott Kelli, Tovar Alison
Department of Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, Providence, RI, USA.
Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.
Pilot Feasibility Stud. 2024 Mar 23;10(1):51. doi: 10.1186/s40814-024-01467-7.
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.
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.
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.
Clinical trials: NCT05941403 , Registered June 9, 2023.
粮食不安全在美国很常见，尤其是在罗德岛州，该州高达33%的居民受到影响。粮食不安全与不良健康后果相关，并且对少数族裔背景的人群影响尤为严重。农产品处方计划中，医疗保健提供者为免费或低成本蔬菜开具“处方”，该计划已被用于解决粮食不安全和与饮食相关的慢性病问题。尽管越来越多的证据表明农产品处方计划在改善粮食安全和饮食质量方面具有有效性，但很少有人努力运用实施科学方法来提高这些计划的采用率。
这项两阶段的试点研究将考察一项现有农产品处方计划的决定因素、初步实施情况及有效性结果。该现有计划由罗德岛州的一个责任医疗组织资助，并在初级保健机构中实施。在第一阶段，我们以实施研究综合框架2.0为指导进行了形成性评估，以评估农产品处方计划的障碍、促进因素和现有实施策略。使用快速定性分析方法对形成性评估的回复进行分析，以总结现有的障碍和促进因素。在第二阶段，我们将形成性评估结果提交给一个社区咨询委员会，该委员会由初级保健人员、责任医疗组织工作人员以及采购和配送蔬菜的工作人员组成。社区咨询委员会利用这些信息，通过实施蓝图确定并完善了一套实施策略，以支持该计划的采用。在实施蓝图的指导下，我们将进行一项单臂试点研究，以评估实施前提条件（即可行性、可接受性、适宜性、实施氛围、实施准备情况）、实施结果（即采用情况）和初步计划有效性（即粮食和营养安全）。第一阶段已完成，第二阶段正在进行中。
本研究将通过正式评估实施决定因素并制定一套量身定制的实施策略来解决已识别的障碍，从而推进关于农产品处方计划的现有文献。本研究的结果将为未来一项全面的混合型3期研究提供参考，该研究将使用量身定制的实施策略，并评估农产品处方计划的实施情况和有效性结果。
临床试验：NCT05941403，于2023年6月9日注册。
