PATHWEIGH：美国科罗拉多州初级保健中成年患者的实用体重管理：一项阶梯式楔形集群随机试验研究方案。
PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial.
机构信息
Colorado School of Public Health, 13001 East 17th Place, Aurora, CO, 80045, USA.
University of Colorado School of Medicine, 13199 E Montview Blvd Ste 300, Aurora, CO, 80045, USA.
出版信息
Trials. 2022 Jan 10;23(1):26. doi: 10.1186/s13063-021-05954-7.
BACKGROUND
Despite the overwhelming prevalence and health implications of obesity, it is rarely adequately addressed in a health care setting. PATHWEIGH is a pragmatic approach to weight management that uses tools built into the electronic medical record to overcome barriers and guide care. Implementation strategies are employed to facilitate adoption and use of the PATHWEIGH tools and processes. The current study will compare the effectiveness of PATHWEIGH versus standard of care (SOC) on patient weight loss in primary care and explore factors for its successful implementation.
METHODS
A stepped wedge cluster randomized trial design will be used within an effectiveness-implementation hybrid study. Adult patient weight loss and weight loss maintenance will be compared in PATHWEIGH versus SOC in 57 family and internal medicine clinics in a large health system in Colorado, USA. Effectiveness will be evaluated using generalized linear mixed models to determine statistical differences in weight loss and weight loss maintenance at 6, 12, and 18 months. Patient-, provider-, and clinic-level predictors will be identified using mediator and moderator analyses. Conceptually guided by the Practical, Robust, Implementation and Sustainability Model (PRISM), a mixed methods approach including quantitative (practice surveys, use tracking) and qualitative (interviews, observations) data collection will be used to determine factors impeding and facilitating adoption, implementation, and maintenance of PATHWEIGH and evaluate specified implementation strategies. A cost analysis of the practice and system costs and resources required by PATHWEIGH relative to the reimbursement collected will be performed.
DISCUSSION
The effectiveness and implementation of PATHWEIGH, and their interrelatedness, for patient weight loss are collectively the focus of the current trial. Findings from this study are expected to serve as a blueprint for available and effective weight management in primary care medical practice.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04678752 . Registered on December 21, 2020.
背景
尽管肥胖的普遍程度及其对健康的影响令人担忧，但在医疗保健环境中，肥胖问题往往得不到充分解决。PATHWEIGH 是一种实用的体重管理方法，它利用电子病历中的工具来克服障碍并指导护理。实施策略用于促进 PATHWEIGH 工具和流程的采用和使用。本研究将比较 PATHWEIGH 与标准护理（SOC）在初级保健中对患者体重减轻的效果，并探讨其成功实施的因素。
方法
一项基于有效性-实施混合研究的阶梯式楔形集群随机试验设计将用于本研究。在美国科罗拉多州的一个大型医疗系统中，将在 57 家家庭和内科诊所中比较 PATHWEIGH 与 SOC 对成年患者体重减轻和体重维持的效果。使用广义线性混合模型评估有效性，以确定 6、12 和 18 个月时体重减轻和体重维持的统计学差异。使用中介和调节分析确定患者、提供者和诊所级别的预测因素。通过实用、稳健、实施和可持续性模型（PRISM）的概念指导，采用定量（实践调查、使用跟踪）和定性（访谈、观察）数据收集的混合方法，确定采用、实施和维持 PATHWEIGH 的障碍和促进因素，并评估指定的实施策略。将对 PATHWEIGH 所需的实践和系统成本和资源进行成本分析，并与报销收入进行比较。
讨论
PATHWEIGH 的有效性和实施情况，以及它们之间的相互关系，是当前试验的重点。预计本研究的结果将为初级保健医疗实践中可用和有效的体重管理提供蓝图。
试验注册
ClinicalTrials.gov NCT04678752。于 2020 年 12 月 21 日注册。
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