Hypertension Improvement Project (HIP)

描述（由申请人提供）：高血压影响了25%的美国成年人，并且仍然是心血管疾病的主要原因。只有25%的高血压患者达到目标血压（BP）。高血压改善项目（HIP）是一项随机对照试验，旨在测试医生持续质量改善（CQI）干预和患者行为干预对血压控制的单独和联合效果。医生将从杜克初级保健研究联盟的实践中选择，为低收入和少数民族人群服务。实践被随机分配到医生（MD）干预或MD控制条件。在这些实践中，所有医学博士都接受相同的干预，他们的患者被单独随机分配到患者干预组或患者常规护理组。MD干预包括三个主要要素：在线培训模块；一种用于临床的评估与治疗算法以及CQI程序，包括评估临床表现措施，并向医生反馈他们遵守指导方针的情况。收集18个月的业绩数据，每3个月向MDs反馈一次。来自这些诊所的患者（约50%为女性，至少40%为非洲裔美国人，90%为低收入者）将被随机分配到患者干预组或常规护理组。患者干预包括为期6个月的行为干预，旨在改变生活方式以降低血压，并坚持服用处方降压药物。在干预结束和一年后（即随机化后6个月和18个月）进行血压和其他随访测量。主要结局是每个治疗组患者在6个月时血压得到充分控制的比例。血压控制由JNC-6目标定义（大多数患者收缩压< 140和舒张压< 90 mmHg；心血管或肾脏疾病或糖尿病患者目标较低）。其他结果包括18个月时血压控制，医生遵守国家指南，患者遵守生活方式建议和药物治疗方案。成本分析也将完成。该研究将在10个诊所招募400名患者（大约20名医生），并将有80%的能力检测到0.3的主要结果效应量。HIP研究将测试可广泛实施的改善高血压控制和降低心血管疾病风险的实际干预措施。

DESCRIPTION (provided by applicant): Hypertension affects 25 % of the adult US population overall and remains a leading cause of cardiovascular disease. Only 25 % of people with hypertension are at goal blood pressure (BP). The Hypertension Improvement Project (HIP) is a randomized, controlled trial that will test the separate and combined effects on BP control of a continuous quality improvement (CQI) intervention for physicians and a behavioral intervention for patients. Physicians will be selected from practices in the Duke Primary Care Research Consortium that serve low income and minority populations. Practices are randomly assigned to the physician (MD) intervention or to the MD control condition. Within these practices, all MDs receive the same intervention, and their patients are individually randomized to the patient intervention or to the patient usual care condition. The MD intervention consists of three main elements: on-line training modules; an evaluation and treatment algorithm for use in the clinic; and a CQI procedure involving assessment of Clinical Performance Measures and feedback to physicians on their adherence to guidelines. The performance data will be collected for 18 months and feedback will be provided to MDs every 3 months. Patients from these practices (approximately 50% women, at least 40% African American, 90% low income) will be randomly assigned to the patient intervention or usual care. The patient intervention consists of a 6-month behavioral intervention aimed at lifestyle changes to lower BP and adherence to prescribed BP medications. BP and other follow-up measurements are performed at the end of the intervention and a year later (i.e., at 6 and 18 months postrandomization). The primary outcome is the proportion of patients in each treatment group that have adequate BP control at 6 months. BP control is defined by JNC-6 goals (systolic BP < 140 and diastolic BP < 90 mmHg for most patients; lower goals for patients with cardiovascular or renal disease or diabetes). Other outcomes include BP control at 18 months, physician adherence to national guidelines, and patient adherence to lifestyle recommendations and medication regimens. A cost analysis will also be done. The study will enroll 400 patients in 10 practices (approximately 20 physicians), and will have 80% power to detect an effect size of 0.3 for the primary outcome. The HIP study will test practical interventions for improving hypertension control that can be broadly implemented and reduce CVD risk.