A pragmatic randomized controlled trial assessing the impact of medically tailored meals and medical nutrition therapy via telehealth among patients with poorly controlled diabetes

一项实用的随机对照试验，评估通过远程医疗进行医学定制膳食和医学营养治疗对控制不佳的糖尿病患者的影响

• 批准号: 9979850
• 负责人: Kristin Laura Rising
• 金额: $ 66.31万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-18 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9979850
• 关键词: Address; African American; American; Behavior; Cause of Death; Chronic Disease; Client satisfaction; Clinical; Clinical Trials; Collaborations; Communities; Cost Analysis; Counseling; Data; Decision Making; Diabetes Mellitus; Diet; Diet and Nutrition; Disadvantaged; Disease Management; Effectiveness; Food; Food Access; Food Services; Glycosylated hemoglobin A; Goals; Health; Health Care Costs; Health Food; Health system; Healthcare Systems; High Prevalence; Improve Access; Individual; Intervention; Lead; Logistics; Low income; Measures; Medical; Medical Nutrition Therapy; Medicine; Modeling; Non-Insulin-Dependent Diabetes Mellitus; Nonprofit Organizations; Outcome; Patient-Focused Outcomes; Patients; Persons; Pilot Projects; Provider; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Research; Research Personnel; Schedule; Self Care; Self Efficacy; Services; Structure; System; Telemedicine; Testing; Therapeutic Intervention; Treatment Failure; Visit; Weight; Work; arm; base; care costs; care delivery; comparison intervention; cost effectiveness; disparity reduction; effectiveness evaluation; evidence base; experience; glycemic control; health care service utilization; high risk; improved; improved outcome; innovation; interest; novel; nutrition; nutrition education; patient oriented; patient population; patient-level barriers; primary outcome; programs; randomized trial; routine practice; secondary outcome; success; telehealth; treatment arm; treatment as usual; uptake

PROJECT SUMMARY Despite the availability of evidence-based guidance and treatments, many patients with diabetes mellitus (DM) do not achieve optimal glycemic control. In prior work, patients with DM identified primary needs of improved access to food and nutrition education. Several innovative models for food services have emerged to address patient needs for improved healthy food access. Currently, select non-profit organizations across the U.S. deliver millions of medically-tailored meals (MTM) to patients with chronic illnesses, based on the premise that food can be as helpful as medicine in improving patient outcomes. While a handful of pilot studies have demonstrated success of MTM in reducing healthcare utilization and hemoglobin A1c (HbA1c) among patients with DM, no randomized trials have assessed the sustained impact of MTM on long-term outcomes for patients with DM. Similarly, individual studies of medical nutrition therapy (MNT), which includes individualized nutrition education and counseling, have shown benefit for improving DM outcomes. However, uptake of MNT across health systems has historically been extremely limited because of patient logistical barriers to attending the in- person visits. MNT delivered by telehealth (tele-MNT) has potential to overcome these barriers. Our goal is to evaluate the effect of MTM, with and without additional tele-MNT, on outcomes for patients with poorly controlled type 2 DM. We will conduct a pragmatic randomized controlled trial with patients who have poorly controlled DM. Outcomes of interest include change in HbA1c, cost effectiveness, weight, diabetes self- efficacy, self-care, diabetes quality of life, and patient satisfaction. We will assess the efficacy of 1) MTM and 2) MTM + tele-MNT compared to usual care in reducing HbA1c at 3, 6 (primary outcome) and 12 months and the cost effectiveness of each intervention compared to usual care up to 12 months. We will also explore patient perspectives regarding experiences with MTM and MTM + tele-MNT to gain a better understanding of potential factors contributing to treatment failure and success within each group. The proposed research is innovative because it develops and tests a novel tele-MNT intervention tailored to recipients of MTM, provides a comprehensive solution to patient-identified nutrition needs, includes complete utilization data provided by the HealthShare Exchange, and leverages a unique health system and community group partnership to improve sustainability and scalability. Study results will inform 1) provider and payor decisions regarding offering and covering these services; 2) how services should be structured for scalability; and 3) integration of these services into the larger care delivery system to reduce DM disparities.

项目总结 尽管有循证指导和治疗，但许多糖尿病(DM)患者 不能达到最佳的血糖控制。在先前的工作中，糖尿病患者确定了改善的主要需求 获得食物和营养教育。出现了几种创新的食品服务模式来解决 患者对改善健康食品获取的需求。目前，美国各地选定的非营利组织。 向慢性病患者提供数百万份医疗定制餐(MTM)，前提是 在改善患者预后方面，食物和药物一样有帮助。虽然一些试点研究已经 MTM在降低患者的医疗保健利用率和血红蛋白A1c(HbA1c)方面取得了成功 对于糖尿病，没有随机试验评估MTM对患者长期结局的持续影响 和DM一起。同样，包括个体化营养的医疗营养疗法(MNT)的个别研究 教育和咨询，已经显示出对改善糖尿病结果的好处。然而，MNT在全球的摄入量 由于病人的后勤障碍，卫生系统在历史上一直是极其有限的- 亲临现场。通过远程保健提供的MNT(Tele-MNT)具有克服这些障碍的潜力。我们的目标是 评估MTM在附加和不附加远程移植的情况下对不良患者预后的影响 受控型2型糖尿病。我们将对健康状况不佳的患者进行务实的随机对照试验 受控糖尿病。感兴趣的结果包括HbA1c、成本效益、体重、糖尿病自身的变化 疗效、自我护理、糖尿病生活质量和患者满意度。我们将评估1)MTM和 2)MTM+Tele-MNT与常规护理在降低3、6(主要结局)和12个月HbA1c方面的比较 与常规护理相比，每次干预的成本效益最高可达12个月。我们还将探索 患者对MTM和MTM+Tele-MNT经验的看法，以更好地了解 每组治疗失败和成功的潜在因素。拟议的研究是 创新是因为它开发和测试了一种为MTM接受者量身定做的新型远程MNT干预，提供了 针对患者确定的营养需求的全面解决方案，包括由 HealthShare Exchange，并利用独特的医疗系统和社区团体合作伙伴关系 提高可持续性和可扩展性。研究结果将通知1)提供者和付款人关于以下方面的决策 提供和覆盖这些服务；2)应如何构建服务以实现可扩展性；3)集成 将这些服务纳入更大的护理提供系统，以减少糖尿病差异。