通过提供“吃得健康”处方农产品补贴来解决糖尿病患者和面临粮食不安全风险人群的健康饮食费用障碍：1 型混合有效性实施实用随机对照试验的研究方案。
Addressing cost barriers to healthy eating with Eat Well, a prescription produce subsidy, for patients with diabetes and at risk for food insecurity: Study protocol for a type 1 hybrid effectiveness-implementation pragmatic randomized controlled trial.
机构信息
Department of Population Health Sciences, Duke University School of Medicine, 215 Morris St, Durham, NC 27701, USA; Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, 411 West Chapel Hill St, Durham, NC 27701, USA.
Department of Population Health Sciences, Duke University School of Medicine, 215 Morris St, Durham, NC 27701, USA; Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, 411 West Chapel Hill St, Durham, NC 27701, USA; Duke Center for Childhood Obesity Research, Duke University School of Medicine, 3116 N. Duke Street, Room 1028, Durham, NC 27704, USA.
出版信息
Contemp Clin Trials. 2024 Oct;145:107655. doi: 10.1016/j.cct.2024.107655. Epub 2024 Aug 5.
BACKGROUND
Patients with diabetes at risk of food insecurity face cost barriers to healthy eating and, as a result, poor health outcomes. Population health management strategies are needed to improve food security in real-world health system settings. We seek to test the effect of a prescription produce program, 'Eat Well' on cardiometabolic health and healthcare utilization. We will also assess the implementation of an automated, affirmative outreach strategy.
METHODS
We will recruit approximately 2400 patients from an integrated academic health system in the southeastern United States as part of a two-arm parallel hybrid type 1 pragmatic randomized controlled trial. Patients with diabetes, at risk for food insecurity, and a recent hemoglobin A1c reading will be eligible to participate. The intervention arm receives, 'Eat Well', which provides a debit card with $80 (added monthly) for 12 months valid for fresh, frozen, or canned fruits and vegetables across grocery retailers. The control arm does not. Both arms receive educational resources with diabetes nutrition and self-management materials, and information on existing care management resources. Using an intent-to-treat analysis, primary outcomes include hemoglobin A1C levels and emergency department visits in the 12 months following enrollment. Reach and fidelity data will be collected to assess implementation.
DISCUSSION
Addressing food insecurity, particularly among those at heightened cardiometabolic risk, is critical to equitable and effective population health management. Pragmatic trials provide important insights into the effectiveness and implementation of 'Eat Well' and approaches like it in real-world settings.
REGISTRATION
ClinicalTrials.gov Identifier: NCT05896644; Clinical Trial Registration Date: 2023-06-09.
背景
面临食物无保障风险的糖尿病患者在健康饮食方面面临着费用障碍，因此健康状况不佳。需要实施人口健康管理策略，以改善现实卫生系统环境中的粮食安全。我们旨在检验“吃得好”（Eat Well）处方农产品计划对心血管代谢健康和医疗保健利用的影响。我们还将评估自动化肯定性外展策略的实施情况。
方法
我们将从美国东南部的一个综合学术医疗系统中招募约 2400 名患有糖尿病、面临食物无保障风险且最近有血红蛋白 A1c 读数的患者，作为一项两臂平行混合 1 型实用随机对照试验的一部分。符合条件的患者将参与干预组（接受“吃得好”计划，该计划为患者提供一张 80 美元（每月增加）的借记卡，有效期 12 个月，可在杂货店零售商处购买新鲜、冷冻或罐装水果和蔬菜）或对照组（不接受“吃得好”计划）。两组都将获得糖尿病营养和自我管理材料以及现有护理管理资源的教育资源。采用意向治疗分析，主要结果包括 12 个月内的血红蛋白 A1C 水平和急诊就诊情况。将收集到达和保真度数据，以评估实施情况。
讨论
解决食物无保障问题，特别是在那些处于较高心血管代谢风险的人群中，对于公平有效的人口健康管理至关重要。实用试验为“吃得好”（Eat Well）及类似方法在现实环境中的有效性和实施提供了重要见解。
注册
ClinicalTrials.gov 标识符：NCT05896644；临床试验注册日期：2023 年 6 月 9 日。
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