Hypertension Improvement Project (HIP): study protocol and implementation challenges
Hypertension Improvement Project (HIP): study protocol and implementation challenges
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DOI：
10.1186/1745-6215-10-13
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发表时间：
2009-02-26
期刊：
影响因子：
2.5
通讯作者：
Svetkey, Laura P.
中科院分区：
文献类型：
--
作者：
Dolor, Rowena J.;Yancy, William S., Jr.;Svetkey, Laura P.
背景：高血压影响29%的美国成年人。S.是心脏病、中风和肾衰竭的主要原因。尽管有许多有效的治疗方法，但只有53%的高血压患者达到目标血压。慢性护理模式表明，血压控制可以通过改善患者和医生如何解决患者self-care.Methods和设计：本文介绍了一个嵌套的2 × 2随机对照试验的协议，以测试单独和合并的影响收缩压的行为干预患者和质量改进型干预医生。初级保健实践被随机分配到医生干预或医生控制条件。医生随机化发生在诊所水平。医生干预包括培训和性能监测。培训包括2个基于互联网的模块，详细介绍了JNC-7高血压指南和高血压的生活方式改变。收集18个月的性能数据，每3个月向医生提供一次反馈。干预和对照诊所的患者参与者被单独随机分配至患者干预或常规护理。患者干预包括6个月的行为干预，由训练有素的干预人员进行20组会议，然后由社区健康顾问每月12次电话联系。在6个月和18个月时进行随访测量。主要结果是6个月时收缩压的平均变化。次要结果是舒张压和在6和18 months.Discussion充分控制血压的患者比例：总体而言，8个实践（4个治疗组），32名医生（4个实践; 16个治疗组），和574例患者（289控制和285干预）入组。提出了患者和提供者的基线特征以及研究实施过程中面临的挑战。HIP干预措施可以通过解决慢性护理模式的关键组成部分，在初级保健实践环境中改善血压控制并降低心血管疾病风险。该研究设计允许分别评估医生和患者干预措施的有效性和成本，以便医疗保健组织能够在当地资源的背景下就实施其中一种或两种干预措施做出明智的决定。试验注册：ClinicalTrials.gov标识符NCT 00201136
Background: Hypertension affects 29% of the adult U. S. population and is a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 53% of people with hypertension are at goal blood pressure. The chronic care model suggests that blood pressure control can be achieved by improving how patients and physicians address patient self-care.Methods and design: This paper describes the protocol of a nested 2 x 2 randomized controlled trial to test the separate and combined effects on systolic blood pressure of a behavioral intervention for patients and a quality improvement-type intervention for physicians. Primary care practices were randomly assigned to the physician intervention or to the physician control condition. Physician randomization occurred at the clinic level. The physician intervention included training and performance monitoring. The training comprised 2 internet-based modules detailing both the JNC-7 hypertension guidelines and lifestyle modifications for hypertension. Performance data were collected for 18 months, and feedback was provided to physicians every 3 months. Patient participants in both intervention and control clinics were individually randomized to the patient intervention or to usual care. The patient intervention consisted of a 6-month behavioral intervention conducted by trained interventionists in 20 group sessions, followed by 12 monthly phone contacts by community health advisors. Follow-up measurements were performed at 6 and 18 months. The primary outcome was the mean change in systolic blood pressure at 6 months. Secondary outcomes were diastolic blood pressure and the proportion of patients with adequate blood pressure control at 6 and 18 months.Discussion: Overall, 8 practices (4 per treatment group), 32 physicians (4 per practice; 16 per treatment group), and 574 patients (289 control and 285 intervention) were enrolled. Baseline characteristics of patients and providers and the challenges faced during study implementation are presented. The HIP interventions may improve blood pressure control and lower cardiovascular disease risk in a primary care practice setting by addressing key components of the chronic care model. The study design allows an assessment of the effectiveness and cost of physician and patient interventions separately, so that health care organizations can make informed decisions about implementation of 1 or both interventions in the context of local resources.Trial registration: ClinicalTrials.gov identifier NCT00201136