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。有 非常需要干预措施，可以帮助长期维持健康的体重， 可持续地融入现有的医疗保健团队。我们开发并测试了一种创新的砝码 损失维持干预-通过技术辅助创新维持活动和营养， 初级保健（MAINTAIN-pc）-通过电子健康记录（EHR）提供，以帮助患者保持 最近有意减肥和成功的生活方式策略。我们已经进行并公布了结果， 来自匹兹堡大学的MAINTAIN-pc随机临床试验，发现参与者 接受EHR跟踪工具和个性化指导的患者在24个月时体重反弹明显较低 （主要结果）比单独接受EHR跟踪工具的参与者。MAINTAIN-pc杠杆 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 及其提供者持续努力维持减肥。尽管MAINTAIN-PC取得了成功，但两个关键因素 关于这种干预的实用性和可持续性的问题仍然没有答案：㈠是否 HIT可以在其他地点进行调整，以及（ii）是否可以利用 现有的人力资源，而不是由研究补助金支持的干预人员。我们提出了一个 一项实用的临床试验，旨在测试MAINTAIN-pc协议在常规医疗保健中的实施和影响 设置：MAINTAIN PRIME（促进真实的（世界）实现）。维护预充将在 附属于犹他州大学的14个初级保健实践，并将利用HIT的进一步发展 (e.g.,跟踪患者人群的仪表板）和基于团队的护理模式， 研究人员的最小支持。Maintain Prime将衡量成本，以告知未来的可持续性， 将研究工作流程和个人，临床和组织属性，以确定促进者和障碍， 成功实施。我们建议的项目将包括三个阶段：1）实施前，我们 将与诊所和IT团队进行协作实施设计，并进行先锋实施映射; 2） 实施，其中我们将进行一项务实的临床试验，在24个月时改变体重， 主要结局;以及3）实施后，我们将评估MAINTAIN PRIME的成功， 包括障碍、促进因素和成本，这些因素将为未来的可持续性提供信息，并总结为“工具包”， 促进传播。通过关注体重维持和复发预防，增加使用现有的 工作人员，并与HIT系统和工具的集成，我们将填补肥胖症长期治疗的关键空白 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.