Promoting Real World Implementation of an Evidence-Based Weight Management Intervention in Primary Care

摘要 肥胖是美国的一个主要健康问题，与糖尿病风险增加有关。的确有 非常需要能够帮助长期保持健康体重的干预措施， 可持续地整合到现有的医疗团队中。我们已经开发并测试了一种创新的称重 损失维护干预-通过技术辅助创新的维护活动和营养 初级保健(Maintain-PC)-通过电子健康记录(EHR)提供，帮助患者维持 最近有意减肥和成功的生活方式策略。我们已经进行并发布了结果 来自匹兹堡大学的Maintain-PC的随机临床试验，发现 接受EHR跟踪工具和个性化教练的患者在24个月后体重恢复显著较低 (主要结果)比只接受电子健康记录跟踪工具的参与者要好。维护-利用PC 常用的健康信息技术(HIT)工具，用于跟踪参与者的进展并支持患者 和他们的供应商正在努力保持减肥。尽管Maintain-PC取得了成功，但两个关键 关于这一干预的实用性和可持续性的问题仍未得到回答：(一)是否 这部热剧可以在其他网站上改编，以及(Ii)是否可以利用 现有的工作人员资源，而不是由研究补助金支持的干预者。我们提出了一个 在常规医疗保健中测试维护-PC方案的实施和影响的实用临床试验 设置：维护Prime(促进真实(世界)实施)。维护Prime将在 14个附属于犹他大学的初级保健诊所，并将利用HIT的进一步进展 (例如，用于跟踪患者群体的仪表板)和基于团队的护理模式，以提供干预 研究人员的支持微乎其微。维护Prime将衡量成本，为未来的可持续性提供信息，而且它 将研究工作流程以及个人、临床和组织属性以确定促进者和障碍 成功实施。我们提议的项目将包括三个阶段：1)实施前，在这一阶段，我们 将与诊所和IT团队进行协作实施设计，并绘制先锋实施图；2) 实施中，我们将进行一项务实的临床试验，在24个月时体重变化作为 初步结果；以及3)实施后，我们将在其中评估维护Prime的成功， 包括障碍、促进者和成本，这些将为未来的可持续发展提供信息，并将其总结为一个“工具包”以 促进传播。通过注重保持体重和预防复发，增加对现有 工作人员，以及与HIT系统和工具的集成，我们将填补肥胖症长期治疗方面的一个关键空白 作为一种慢性疾病。

ABSTRACT Obesity is a major health problem in the United States and associated with increased risk of diabetes. There is a great need for interventions that can assist with long-term maintenance of healthy body weight and be sustainably integrated into existing health care teams. We have developed and tested an innovative weight loss maintenance intervention – Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) – delivered through the electronic health record (EHR) to help patients maintain recent intentional weight loss and successful lifestyle strategies. We have conducted and published results from a randomized clinical trial of MAINTAIN-pc at the University of Pittsburgh and found that participants who received EHR tracking tools and personalized coaching had significantly lower weight regain at 24 months (primary outcome) than participants who received EHR tracking tools alone. MAINTAIN-pc leveraged commonly available health information technology (HIT) tools to track participant progress and support patients and their providers in ongoing efforts to maintain weight loss. Despite the success of MAINTAIN-pc, two key questions about the practicality and sustainability of this intervention remain unanswered: (i) whether the HIT could be adapted at other sites and (ii) whether coaching could be delivered leveraging existing staff resources rather than interventionists supported by a research grant. We propose a pragmatic clinical trial to test the implementation and impact of the MAINTAIN-pc protocol in routine healthcare settings: MAINTAIN PRIME (Promoting Real (World) IMplEmentation). MAINTAIN PRIME will be conducted in 14 primary care practices affiliated with the University of Utah and will capitalize on further advances in HIT (e.g., dashboards to track patient populations) and team-based care models to deliver the intervention with minimal support from research staff. MAINTAIN PRIME will measure costs to inform future sustainability, and it will study workflow and individual, clinical, and organizational attributes to determine facilitators and barriers to successful implementation. Our proposed project will include three phases: 1) pre-implementation, in which we will do collaborative implementation design with clinic and IT teams and vanguard implementation mapping; 2) implementation, in which we will conduct a pragmatic clinical trial with weight change at 24 months as the primary outcome; and 3) post-implementation, in which we will evaluate the success of MAINTAIN PRIME, including barriers, facilitators, and costs that will inform future sustainability and be summarized in a “toolkit” to foster dissemination. By focusing on weight maintenance and relapse prevention, increased use of existing staff, and integration with HIT systems and tools, we will fill a crucial gap in the long-term treatment of obesity as a chronic medical condition.