Discovering Healthcare Innovations to Address Disparities in Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,761
- 试验地点
- 2
- 主要终点
- Percentage of Blacks / African Americans with HTY with controlled blood pressure (BP) after 1 year.
研究概览
简要总结
The goal of this pragmatic study is to improve hypertension (HTN) control rate in blacks and to reduce racial disparity in HTN control. To accomplish this, the investigators propose to perform a cluster randomized controlled trial at the primary care provider (PCP) level and including 191 PCPs within KPNC East Bay Service Area with more than 45,000 patients in the HTN registry of which approximately 15,000 are black. The investigators will randomize all PCP patient panels to a three-arm trial to receiving either 1) usual care; or 2) culturally tailored diet and lifestyle coaching; or 3) an intensified BP management protocol with pharmacotherapy. The "Shake, Rattle and Roll" trial is named for: 1) "shake" the salt habit; 2) "rattle" the intensity of current BP management; and 3) design the interventions with the goal of being able to adapt and "roll" them out to community clinics outside of a managed care system. Primary research question: whether a primary prevention intervention of either diet and lifestyle coaching or an intensive pharmacotherapy protocol is more effective than usual care in improving rates of HTN control in blacks and thereby reducing disparities between black and white. Primary aim: By implementing either intervention, the investigators will reduce the disparity in hypertension control rates between blacks and whites by 4% at 1 year post-study enrollment. Hypothesis: Among blacks with HTN, a diet/lifestyle coaching intervention or an intensified BP management protocol will result in an increase in HTN control rate compared to usual care. Primary outcome: the proportion of patients with sustained BP control at 1 year post-study enrollment.
详细描述
Kaiser Permanente Northern California (KPNC) serves a population of over 3 million enrollees, representative of the socio-demographic characteristics of the San Francisco Bay Area, Santa Rosa, and Sacramento except for under-representation of the very rich and very poor.78 KPNC is the largest nonprofit integrated health care organization in the country, with 22 hospitals and 44 outpatient facilities, and cares for 30% of the population in the region. The majority of Californians are managed in four large hospital networks, so the KPNC system is a model for the 167 Program Director/Principal Investigator (Last, First, Middle): Sidney, Stephen, MD, MPH PHS 398/2590 (Rev. 06/09) Page Continuation Format Page prevalent system of care in the state. An effective system-wide intervention in KPNC would likely be generalizable and feasible in the other healthcare networks in the State and, thus, could benefit the population more broadly. The project focuses on the East Bay Service Area (EBSA) because approximately one-third of African American KPNC members with HTN receive care within this geographical area. The East Bay area, home of the flagship Oakland Medical Center and Richmond Medical Center, comprises 12 cities and municipalities within the Alameda County and the western section of Contra Costa County. From Kaiser Permanente's inception in 1945, the nonprofit organization has led with innovation, beginning with its prepaid health care services offered to Richmond shipyard workers during World War II. Today, the Richmond and Oakland Medical Centers are home to about 700 physicians and 5,600 employees who serve over a quarter of a million members yearly.
Kaiser Permanente East Bay has expanded its services for West Contra Costa members. The brand new Pinole Medical Office Building, just eight miles from the Richmond Medical Center offers convenient access to members in the East Bay Area, which includes Pinole, El Sobrante, Hercules, Rodeo and Crockett.
The Pinole center provides adult medicine, family practice, pediatrics, obstetrics/gynecology, radiology, a lab, a pharmacy, and health education. For emergency services, members go to the Richmond Medical Center, and for labor and delivery services, the Oakland Medical Center. The fourth member of the EBSA is the Alameda Medical Center which offers services for internal medicine, gynecology, pediatrics, pharmacy, and members outreach. Using KPNC as a model offers several major advantages. Members generally remain in the plan for many years, with 94% retention at 1 year and 84% retention at 5 years among enrollees 65-74 years old.
Sources of electronic medical data are extensive and easy to manipulate. They will be combined to produce an electronic registry of patients with uncontrolled HTN (Figure - Electronic Registry; source of data provided in brackets). The following information is available from electronic medical record (EMR) system:
- Inpatient discharge abstracts with primary and secondary diagnoses and procedures coded by a trained medical records analyst.
- Inpatient discharge abstracts for all out-of-plan hospital admissions.
- Emergency-department and outpatient diagnoses coded by the treating physician.
- All outpatient records including BP measurements.
- All radiology reports generated by reviewing radiologists.
- Listing of all major health problems generated and frequently updated by all treating physicians.
- Cardiologist interpretations of all ECGs.
- Reports from all clinical laboratory studies.
- Listing of all outpatient filled prescriptions and completed inpatient medication orders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •African American
- •> age 18
- •Blood Pressure >140/90
排除标准
- 未提供
研究组 & 干预措施
Medication enhancement
Pharmacist will optimize current Kaiser medication protocol for treatment of hypertension.
Diet and Lifestyle Arm
Patients will receive up to 16 wellness coaching sessions focusing on DASH doest and lifestyle changes - Behavioral Intervention
干预措施: Diet and Lifestyle (Behavioral)
Usual Care
No Interventions
结局指标
主要结局
Percentage of Blacks / African Americans with HTY with controlled blood pressure (BP) after 1 year.
时间窗: 1 year
Percentage of Blacks / African Americans with HTY with controlled blood pressure (BP) after 1 year.
次要结局
未报告次要终点
