Pragmatic Trial of Technology-Supported Behavioral Obesity Treatment in the Primary Care Setting: A Multiphase Effectiveness and Implementation Hybrid Design

初级保健环境中技术支持的行为肥胖治疗的务实试验：多阶段有效性和实施混合设计

• 批准号: 9752616
• 负责人: John Graham Thomas
• 金额: $ 64.8万
• 依托单位: MIRIAM HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-20 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9752616
• 关键词: Address; Adherence; Behavioral; Body Weight; Body Weight decreased; Boredom; Care given by nurses; Case Manager; Clinical; Cluster randomized trial; Computerized Medical Record; E-learning; Educational process of instructing; Effectiveness; Enrollment; Feedback; Human Resources; Hybrids; Hypertension; Informal Social Control; Information Services; Intervention; Leadership; Light; Maintenance; Modeling; Monitor; Non-Insulin-Dependent Diabetes Mellitus; Nurses; Obesity; Online Systems; Outcome; Overweight; Patient Care; Patients; Pharmaceutical Preparations; Physicians; Physicians' Offices; Practice Management; Pragmatic clinical trial; Primary Care Physician; Primary Health Care; Program Accessibility; Public Health; Randomized; Reporting; Research; Rhode Island; Risk Factors; System; Technology; Testing; Time; Training; Weight; Work; behavior change; cardiovascular disorder risk; cardiovascular risk factor; clinically significant; cost; dashboard; design; health care settings; high risk; hypercholesterolemia; improved; improved outcome; innovation; intervention program; novel strategies; obesity treatment; patient engagement; patient population; pragmatic trial; primary care setting; programs; randomized trial; research study; satisfaction; secondary outcome; skills; skills training; support tools; tool; uptake; weight loss intervention; weight loss program; weight maintenance

PROJECT SUMMARY/ABSTRACT Behavioral obesity treatment produces clinically significant weight loss; for the greatest impact, it should be made available in the primary care setting where it can reach the many patients with overweight/obesity. We have developed a 3-month automated online behavioral weight loss program, Rx Weight Loss (RxWL), and shown that it produces clinically significant weight losses among primary care patients. Our early efforts at pragmatic implementation of RxWL have been promising, and have shed light on challenges associated with implementation, and the need to study longer-term effectiveness. We therefore propose to conduct a pragmatic study to improve the implementation and effectiveness of this behavioral obesity intervention delivered in routine and representative healthcare settings. We are partnering with the Rhode Island Primary Care Physicians Corporation (RIPCPC), a large primary care network of 58 practices with 100 physicians and 16 nurse care managers. Using the framework for Effectiveness-Implementation Hybrid Designs, we will simultaneously target effectiveness and implementation to maximize the public health impact of our research. We will randomly assign half of the 16 nurse care managers, and the practices they serve, to either Basic Implementation (alerts in the electronic medical record [EMR] to direct eligible patients to RxWL), or to the Enhanced Implementation (alerts, clinician skills training to motivate and support weight loss, clinician dashboard with reports on patient progress and tools to facilitate patient engagement and behavior change). We will test the hypothesis that the Enhanced Implementation will increase the proportion of patients directed to, enrolling, and completing the weight loss program. Because maintenance of weight loss is a critical problem, this project will also involve randomization of 600 patients with overweight/obesity and type 2 diabetes, hypertension, and/or hypercholesterolemia to the 3 month RxWL intervention followed by one of three maintenance conditions: (a) Control- 9 monthly online education sessions; (b) Monthly Lessons and Feedback- 9 monthly online video lessons teaching self-regulation with automated feedback on the self-monitoring record; (c) Refresher Campaigns- 9 monthly on-line video sessions, teaching self-regulation and providing two 4-week courses with novel strategies and behavioral challenges to improve long-term outcomes. We will test the hypothesis that 12-month weight losses are better with Refresher Campaigns than Monthly Lessons and Feedback, and both are better than Control. Secondary outcomes include changes in weight, CVD risk factors, and medication use over a full 24 months. Our project is significant and innovative because: it uses an empirically validated approach to obesity treatment that is integrated into the primary care setting, leveraging existing staff and EMR capabilities; it has a dual focus on improving effectiveness and implementation; it has a pragmatic design in partnership with a large primary care network that treats a diverse patient population; and it has potential to it provides a scalable, sustainable approach that can serve as a model for broader dissemination of obesity treatment intervention.

项目概要/摘要 行为性肥胖治疗可产生临床显着的体重减轻；为了达到最大的影响，应该是 在初级保健机构中提供，可以惠及许多超重/肥胖患者。我们 开发了为期 3 个月的自动在线行为减肥计划 Rx Weight Loss (RxWL)，以及 研究表明，它可以在初级保健患者中产生临床上显着的体重减轻。我们早期的努力 RxWL 的务实实施一直充满希望，并揭示了与 实施，并需要研究长期有效性。因此，我们建议开展务实的 研究旨在改善日常行为肥胖干预措施的实施和有效性 和代表性的医疗保健机构。我们正在与罗德岛初级保健医生合作 Corporation (RIPCPC)，一个大型初级保健网络，拥有 58 个诊所、100 名医生和 16 名护士 经理。使用有效性-实施混合设计框架，我们将同时瞄准 有效性和实施，以最大限度地发挥我们研究的公共卫生影响。我们将随机分配 16 名护士护理经理中的一半以及他们所服务的实践，要么基本实施（在 电子病历 [EMR] 将符合条件的患者引导至 RxWL）或增强实施（警报、 临床医生技能培训，以激励和支持减肥，临床医生仪表板包含患者进展报告 以及促进患者参与和行为改变的工具）。我们将测试增强型的假设 实施将增加指导、登记和完成减肥的患者比例 程序。由于维持减肥是一个关键问题，因此该项目还将涉及随机化 600 名超重/肥胖和 2 型糖尿病、高血压和/或高胆固醇血症患者至 3 月 RxWL 干预，然后是以下三种维护条件之一： (a) 控制 - 9 个月在线 教育课程； (b) 每月课程和反馈 - 每月 9 节在线视频课程教授自我调节 对自我监控记录进行自动反馈； (c) 复习活动 - 9 个月在线视频 会议，教授自我调节并提供两个为期 4 周的课程，其中包含新颖的策略和行为 改善长期成果的挑战。我们将检验 12 个月减肥效果更好的假设 复习活动比每月课程和反馈更好，两者都比控制更好。中学 结果包括体重变化、CVD 危险因素以及整整 24 个月内的药物使用情况。 我们的项目意义重大且具有创新性，因为：它采用了经过经验验证的肥胖方法 利用现有工作人员和电子病历（EMR）能力，将治疗纳入初级保健环境；它有一个 注重提高有效性和执行力；它与大型企业合作，采用务实的设计 治疗不同患者群体的初级保健网络；它有潜力提供可扩展的、 可持续的方法可以作为更广泛传播肥胖治疗干预措施的模型。