Gary Tiffany L, Batts-Turner Marian, Bone Lee R, Yeh Hsin-Chieh, Wang Nae-Yuh, Hill-Briggs Felicia, Levine David M, Powe Neil R, Hill Martha N, Saudek Christopher, McGuire Maura, Brancati Frederick L
Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Room E6034, Baltimore, MD 21205, USA.
Control Clin Trials. 2004 Feb;25(1):53-66. doi: 10.1016/j.cct.2003.10.010.
The objective of the study was to determine the effectiveness and cost-effectiveness of primary care and community-oriented interventions in managing HbA1c, blood pressure, and lipids, and reducing hospitalizations and emergency room visits over 2 years. We describe an ongoing, randomized controlled trial of 542 urban African-Americans with type 2 diabetes ages 25 years and older who are members of a university-affiliated managed-care organization in Baltimore, MD. The participants are 74% female, have a mean age of 58 years, and 35% have yearly incomes greater than 7500 US dollars. Participants were randomized to one of two intervention groups for a period of 2 years: (1) usual medical care plus minimal telephone intervention implemented by a trained lay health educator (control group) or (2) usual medical care plus intensive intervention implemented by a nurse case manager (NCM)/community health worker (CHW) team. The intensive NCM/CHW team executes individual plans of care using evidence-based algorithms that focus on traditional diabetes self-management, screening and management of diabetes-related complications, and social issues surrounding diabetes care. Face-to-face NCM visits are conducted in the clinic once per year and CHW visits are conducted in the participant's home one to three times per year, both with additional follow-up contacts as needed. Written and verbal feedback (when necessary) is provided to the participant's primary care physician. All participants are expected to attend a 24-month follow-up visit where data are collected by interviewers blinded to intervention assignment. As of May 1, 2003, recruitment is complete, interventions are being fully implemented, and 24-month follow-up visits are beginning. Baseline sociodemographic characteristics, health-care utilization, health behaviors, and clinical characteristics of the study population are reported. This study is designed to test the hypothesis that a primary-care-based NCM plus CHW team approach is an effective, practical, and economically feasible strategy for translating current knowledge about type 2 diabetes into high-quality health care for urban African-Americans.
该研究的目的是确定初级保健和社区导向干预措施在管理糖化血红蛋白、血压和血脂，以及减少两年内住院和急诊就诊次数方面的有效性和成本效益。我们描述了一项正在进行的随机对照试验，该试验针对542名年龄在25岁及以上的城市非裔美国2型糖尿病患者，他们是马里兰州巴尔的摩市一家大学附属管理式医疗组织的成员。参与者中74%为女性，平均年龄58岁，35%的人年收入超过7500美元。参与者被随机分为两个干预组，为期2年：（1）常规医疗护理加由经过培训的非专业健康教育家实施的最少电话干预（对照组），或（2）常规医疗护理加由护士病例管理员（NCM）/社区卫生工作者（CHW）团队实施的强化干预。强化NCM/CHW团队使用基于证据的算法执行个性化护理计划，这些算法侧重于传统糖尿病自我管理、糖尿病相关并发症的筛查和管理，以及围绕糖尿病护理的社会问题。NCM每年在诊所进行一次面对面访视，CHW每年在参与者家中进行一至三次访视，必要时都进行额外的随访联系。向参与者的初级保健医生提供书面和口头反馈（必要时）。所有参与者都预计参加为期24个月的随访访视，由对干预分配不知情的访谈者收集数据。截至2003年5月1日，招募工作已完成，干预措施正在全面实施，24个月的随访访视即将开始。报告了研究人群的基线社会人口学特征、医疗保健利用情况、健康行为和临床特征。本研究旨在检验以下假设：基于初级保健的NCM加CHW团队方法是一种有效、实用且经济可行的策略，能够将当前关于2型糖尿病的知识转化为针对城市非裔美国人的高质量医疗保健。
