Implementation of case management to reduce cardiovascular disease risk in the Stanford and San Mateo Heart to Heart randomized controlled trial: study protocol and baseline characteristics.
Implementation of case management to reduce cardiovascular disease risk in the Stanford and San Mateo Heart to Heart randomized controlled trial: study protocol and baseline characteristics.
复制标题
实施病例管理以减少斯坦福大学和圣马特奥心脏中心血管疾病风险的心脏随机对照试验：研究方案和基线特征。
DOI：
10.1186/1748-5908-1-21
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发表时间：
2006-09-27
影响因子：
7.2
通讯作者：
Stafford, Randall S
中科院分区：
文献类型：
--
作者：
Ma, Jun;Lee, Ky-Van;Berra, Kathy;Stafford, Randall S
病例管理已成为一种有前途的替代方法，以补充传统的一对一的病人和医生之间的会议，以提高慢性疾病，如冠心病（CHD）的护理质量。然而，缺乏在少数民族和低收入人口中实施的有效性和成本效益方面的数据。斯坦福大学和圣马特奥心对心（HTH）项目是一项随机对照临床试验，旨在严格评估加州当地县卫生保健系统服务的低收入，主要是少数民族患者的多风险心血管病例管理计划的疗效和成本效益。随机化发生在患者水平。主要结局指标是10年内的绝对CHD风险。次要结局指标包括对CHD预防实践指南的依从性。我们记录了419名参与者的研究设计、方法学和基线社会人口统计学、临床和生活方式特征。我们实现了两个随机分组之间的社会人口统计学，生物物理学和生活方式特征的平等分布。HTH参与者的平均年龄为56岁，63%为拉丁美洲人/西班牙裔，65%为女性，61%受教育程度较低，62%没有工作。20%的参与者报告有既往心血管事件。10-尽管基线时低密度脂蛋白胆固醇水平适中且治疗百分比较高，但男性和女性的年CHD风险平均为18%和13%。63%的参与者被诊断患有糖尿病，另外22%患有代谢综合征。此外，许多参与者的高密度脂蛋白（HDL）胆固醇水平降低，总胆固醇与HDL比率、甘油三酯、甘油三酯与HDL比率和血压升高。此外，近70%的参与者肥胖，45%有冠心病或中风家族史，16%目前吸烟。我们招募了一个种族多样化的低收入群体，在其中实施病例管理方法，并测试其功效和成本效益。HTH将促进对这些优先亚群中CHD预防的更好策略的科学理解，并帮助指导未来减少健康差距的实践。
Case management has emerged as a promising alternative approach to supplement traditional one-on-one sessions between patients and doctors for improving the quality of care in chronic diseases such as coronary heart disease (CHD). However, data are lacking in terms of its efficacy and cost-effectiveness when implemented in ethnic and low-income populations. The Stanford and San Mateo Heart to Heart (HTH) project is a randomized controlled clinical trial designed to rigorously evaluate the efficacy and cost-effectiveness of a multi-risk cardiovascular case management program in low-income, primarily ethnic minority patients served by a local county health care system in California. Randomization occurred at the patient level. The primary outcome measure is the absolute CHD risk over 10 years. Secondary outcome measures include adherence to guidelines on CHD prevention practice. We documented the study design, methodology, and baseline sociodemographic, clinical and lifestyle characteristics of 419 participants. We achieved equal distributions of the sociodemographic, biophysical and lifestyle characteristics between the two randomization groups. HTH participants had a mean age of 56 years, 63% were Latinos/Hispanics, 65% female, 61% less educated, and 62% were not employed. Twenty percent of participants reported having a prior cardiovascular event. 10-year CHD risk averaged 18% in men and 13% in women despite a modest low-density lipoprotein cholesterol level and a high on-treatment percentage at baseline. Sixty-three percent of participants were diagnosed with diabetes and an additional 22% had metabolic syndrome. In addition, many participants had depressed high-density lipoprotein (HDL) cholesterol levels and elevated values of total cholesterol-to-HDL ratio, triglycerides, triglyceride-to-HDL ratio, and blood pressure. Furthermore, nearly 70% of participants were obese, 45% had a family history of CHD or stroke, and 16% were current smokers. We have recruited an ethnically diverse, low-income cohort in which to implement a case management approach and test its efficacy and cost-effectiveness. HTH will advance the scientific understanding of better strategies for CHD prevention among these priority subpopulations and aid in guiding future practice that will reduce health disparities.