Design of a cluster-randomized trial of electronic health record-based tools to address overweight and obesity in primary care.
Design of a cluster-randomized trial of electronic health record-based tools to address overweight and obesity in primary care.
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DOI：
10.1177/1740774515578132
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发表时间：
2015-08
期刊：
影响因子：
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通讯作者：
Bates DW
中科院分区：
文献类型：
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作者：
Baer HJ;Wee CC;DeVito K;Orav EJ;Frolkis JP;Williams DH;Wright A;Bates DW
初级保健提供者往往无法识别超重或肥胖的患者或与他们讨论体重管理。基于电子健康记录（EHR）的工具可以帮助提供者评估和管理超重和肥胖。我们描述了一项试验的设计，以检查EHR为基础的工具的有效性，评估和管理超重和肥胖的成人初级保健患者，以及我们遇到的挑战。我们在马萨诸塞州波士顿布里格姆妇女医院附属的初级保健实践中使用的EHR中开发了几个新功能。这些功能包括：1）测量身高和体重的提醒; 2）要求提供者将超重或肥胖添加到问题列表的警报; 3）具有定制管理建议的提醒;以及4）体重管理屏幕。然后，我们在12个初级保健实践中进行了一项务实的随机分组对照试验。我们将23个临床团队（“诊所”）随机分为干预组（n = 11）或对照组（n = 12）。新功能仅在干预组的诊所中激活。干预分2个阶段实施;身高和体重提醒于2011年12月15日上线（第1阶段），所有其他功能于2012年6月11日上线（第2阶段）。研究入组时间为2011年12月至2012年12月，随访于2013年12月结束。主要结局为II期期间在一家初级保健诊所就诊的BMI ≥ 25的成人患者的6个月和12个月体重变化。次要结局指标包括在EHR中记录BMI的患者比例;在EHR问题列表中诊断为超重或肥胖的BMI ≥ 25的患者比例;以及BMI ≥ 25的患者对体重进行随访或处方减肥药物的比例。我们遇到了挑战，在我们的发展干预现有的结构内的电子健康记录。例如，尽管我们决定在初级保健实践中随机分配诊所，但这一决定可能会引入污染，并导致干预和控制实践之间的患者特征存在一些不平衡。使用EHR作为主要数据源降低了研究成本，但并不是每个参与者都记录了所有所需的数据。尽管面临挑战，这项研究应该提供有关EHR为基础的工具，以解决超重和肥胖的初级保健的有效性有价值的信息。
Primary care providers often fail to identify patients who are overweight or obese or discuss weight management with them. Electronic health record (EHR)-based tools may help providers with the assessment and management of overweight and obesity. We describe the design of a trial to examine the effectiveness of EHR-based tools for the assessment and management of overweight and obesity among adult primary care patients, as well as the challenges we encountered. We developed several new features within the EHR used by primary care practices affiliated with Brigham and Women’s Hospital in Boston, MA. These features included: 1) reminders to measure height and weight; 2) an alert asking providers to add overweight or obesity to the problem list; 3) reminders with tailored management recommendations; and 4) a Weight Management screen. We then conducted a pragmatic, cluster-randomized controlled trial in 12 primary care practices. We randomized 23 clinical teams (“clinics”) within the practices to the intervention group (n = 11) or the control group (n = 12). The new features were activated only for clinics in the intervention group. The intervention was implemented in 2 phases; the height and weight reminders went live on December 15, 2011 (Phase 1), and all of the other features went live on June 11, 2012 (Phase 2). Study enrollment went from December 2011 through December 2012, and follow-up ended in December 2013. The primary outcomes were 6-month and 12-month weight change among adult patients with BMI ≥ 25 who had a visit at one of the primary care clinics during Phase 2. Secondary outcome measures included the proportion of patients with a recorded BMI in the EHR; the proportion of patients with BMI ≥ 25 who had a diagnosis of overweight or obesity on the EHR problem list; and the proportion of patients with BMI ≥ 25 who had a follow-up appointment about their weight or were prescribed weight loss medication. We encountered challenges in our development of an intervention within the existing structure of an EHR. For example, although we decided to randomize clinics within primary care practices, this decision may have introduced contamination and led to some imbalance of patient characteristics between the intervention and control practices. Using the EHR as the primary data source reduced the cost of the study, but not all desired data were recorded for every participant. Despite the challenges, this study should provide valuable information about the effectiveness of EHR-based tools for addressing overweight and obesity in primary care.