PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial.

PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial.
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DOI:
10.1186/s13063-021-05954-7
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发表时间:
2022-01-10
期刊:
影响因子:
2.5
通讯作者:
Perreault L
Perreault L
中科院分区:
医学4区
文献类型:
--
作者:
Suresh K;Holtrop JS;Dickinson LM;Willems E;Smith PC;Gritz RM;Perreault L

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尽管肥胖具有压倒性的普遍性和健康影响,但在卫生保健环境中很少得到充分解决。path称重是一种实用的体重管理方法,它使用内置在电子病历中的工具来克服障碍并指导护理。采用实施策略来促进pathweight工具和过程的采用和使用。目前的研究将比较pathweight和标准护理(SOC)在初级保健患者体重减轻方面的有效性,并探讨其成功实施的因素。在一项有效性-实施的混合研究中,将采用阶梯楔形聚类随机试验设计。在美国科罗拉多州一个大型卫生系统的57个家庭和内科诊所中,将pathweight与SOC比较成年患者的体重减轻和体重维持情况。将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差异。患者、提供者和临床水平的预测因子将使用中介和调节分析来确定。在实用、稳健、实施和可持续性模型(PRISM)的概念指导下,将采用混合方法,包括定量(实践调查、使用跟踪)和定性(访谈、观察)数据收集,以确定阻碍和促进pathweight采用、实施和维护的因素,并评估特定的实施策略。将执行与所收集的报销相关的实践和系统成本以及path称重所需资源的成本分析。pathweight对患者减肥的有效性和实施,以及它们之间的相互关系,是当前试验的重点。本研究的结果有望作为初级保健医疗实践中可用和有效的体重管理的蓝图。ClinicalTrials.govNCT04678752。2020年12月21日注册。在线版本包含补充材料,可在10.1186/s13063- 021-059554 -7获得。
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. 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. 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. ClinicalTrials.govNCT04678752. Registered on December 21, 2020. The online version contains supplementary material available at 10.1186/s13063-021-05954-7.
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