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STAR 随机对照试验的原理和设计,旨在加速儿童肥胖症比较效果研究的采用。

Rationale and design of the STAR randomized controlled trial to accelerate adoption of childhood obesity comparative effectiveness research.

机构信息

Obesity Prevention Program, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, United States.

出版信息

Contemp Clin Trials. 2013 Jan;34(1):101-8. doi: 10.1016/j.cct.2012.10.005. Epub 2012 Oct 22.

DOI:10.1016/j.cct.2012.10.005
PMID:23099100
Abstract

BACKGROUND

Comparative effectiveness research (CER) evidence on childhood obesity provides the basis for effective screening and management strategies in pediatric primary care. The uses of health information technology including decision support tools in the electronic health records (EHRs), as well as remote and mobile support to families, offer the potential to accelerate the adoption of childhood obesity CER evidence.

METHODS/DESIGN: The Study of Technology to Accelerate Research (STAR) is a three-arm, cluster-randomized controlled trial being conducted in 14 pediatric offices in Massachusetts designed to enroll 800, 6 to 12 year old children with a body mass index (BMI)≥ 95th percentile seen in primary care at those practices. We will examine the extent to which computerized decision support tools in the EHR delivered to primary care providers at the point of care, with or without direct-to-parent support and coaching, will increase adoption of CER evidence for management of obese children. Direct-to-parent intervention components include telephone coaching and twice-weekly text messages. Point-of-care outcomes include obesity diagnosis, nutrition and physical activity counseling, and referral to weight management. One-year child-level outcomes include changes in BMI and improvements in diet, physical activity, screen time, and sleep behaviors, as well as cost and cost-effectiveness.

CONCLUSIONS

STAR will determine the extent to which decision support tools in EHRs with or without direct-to-parent support will increase adoption of evidence-based obesity management strategies in pediatric practice and improve childhood obesity-related outcomes.

摘要

背景

儿童肥胖症的比较效果研究(CER)证据为儿科初级保健中的有效筛查和管理策略提供了基础。健康信息技术的应用,包括电子健康记录(EHR)中的决策支持工具,以及对家庭的远程和移动支持,有可能加速儿童肥胖 CER 证据的采用。

方法/设计:研究技术加速研究(STAR)是一项三臂、整群随机对照试验,在马萨诸塞州的 14 个儿科办公室进行,旨在招募 800 名 6 至 12 岁的儿童,这些儿童在这些实践中接受初级保健,其体重指数(BMI)≥95 百分位。我们将研究在护理点向初级保健提供者提供的 EHR 中的计算机化决策支持工具,无论是否有直接针对父母的支持和辅导,在多大程度上会增加肥胖儿童管理的 CER 证据的采用。直接针对父母的干预措施包括电话辅导和每周两次的短信。护理点结果包括肥胖诊断、营养和身体活动咨询,以及转介到体重管理。一年后的儿童水平结果包括 BMI 的变化以及饮食、身体活动、屏幕时间和睡眠行为的改善,以及成本和成本效益。

结论

STAR 将确定 EHR 中的决策支持工具,无论是否有直接针对父母的支持,在多大程度上会增加儿科实践中采用循证肥胖管理策略的程度,并改善与儿童肥胖相关的结果。

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