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.

Autor: Drake C; 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. Electronic address: Connor.drake@duke.edu., Granados I; 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., Rader A; Department of Population Health Sciences, Duke University School of Medicine, 215 Morris St, Durham, NC 27701, USA., Brucker A; Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Duke University Medical Center 2424 Erwin Road, Suite 1102 Hock Plaza Box 2721, Durham, NC 27710, United States of America., Hoeffler S; Reinvestment Partners, 110 E Geer St, Durham, North Carolina 27701, United States of America., Goldstein BA; Department of Population Health Sciences, Duke University School of Medicine, 215 Morris St, Durham, NC 27701, USA; Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Duke University Medical Center 2424 Erwin Road, Suite 1102 Hock Plaza Box 2721, Durham, NC 27710, United States of America., Chamorro C; Duke Office of Clinical Research, Duke University School of Medicine, 2200 West Main Street, Durham, NC 27705, United States of America., Johnson F; Duke Population Health Management Office, Duke University Health System, 3100 Tower Blvd Suite 1100, Durham, NC 27707, United States of America; Division of Community Health, Department of Family Medicine and Community Health, Duke University School of Medicine, DUMC 2914, Durham, NC, 27710, United States of America., Hinz EM; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, 40 Duke Medicine Circle, Durham, NC 27710, United States of America., Bedoya AD; Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC 27710, United States of America; Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Duke University Medical Center 2424 Erwin Road, Suite 1102 Hock Plaza Box 2721, Durham, NC 27710, United States of America., German JC; Division of Endocrinology, Metabolism, and Nutrition, Department of Medicine, Duke University School of Medicine, Durham, NC 27710, United States of America., Hauser J; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, 40 Duke Medicine Circle, Durham, NC 27710, United States of America., Thacker C; Division of Endocrinology, Metabolism, and Nutrition, Department of Medicine, Duke University School of Medicine, Durham, NC 27710, United States of America., Spratt SE; Duke Population Health Management Office, Duke University Health System, 3100 Tower Blvd Suite 1100, Durham, NC 27707, United States of America; Division of Endocrinology, Metabolism, and Nutrition, Department of Medicine, Duke University School of Medicine, Durham, NC 27710, United States of America; Division of Community Health, Department of Family Medicine and Community Health, Duke University School of Medicine, DUMC 2914, Durham, NC, 27710, United States of America.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2024 Oct; Vol. 145, pp. 107655. Date of Electronic Publication: 2024 Aug 05.
DOI: 10.1016/j.cct.2024.107655
Abstrakt: 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.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article.
(Published by Elsevier Inc.)
Databáze: MEDLINE
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