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临床试验/NCT01566864
NCT01566864已完成不适用

Multi-Method Health System QI Intervention to Reduce Hypertension Disparities

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 66,570 人开始时间: 2011年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66,570
试验地点
2
主要终点
Percent of clinic patients with controlled blood pressure and the racial disparity in controlled BP at each clinic.

研究概览

简要总结

The investigators have designed a three-part quality improvement intervention to 1) improve the clinic-based measurement of blood pressure, 2) introduce a care management system to promote self-management behaviors and rapidly titrate medications by algorithms developed in accord with guidelines and 3) introduce an interactive, needs-based, longitudinal-provider education system that promotes patient-centered care and provides practical examples of patient-provider communication strategies. The intervention will occur at six clinics within the metropolitan area of Baltimore, Maryland. The investigators will also describe clinic and health system characteristics and measure their association with implementation (uptake), success (improvements in blood pressure control and reductions in racial disparities), and sustainability of the three-part intervention over 12 -24 months.

详细描述

Hypertension is common in the US. From efficacy and observational studies, we know that achieving blood pressure control can reduce morbidity and mortality. However, less than one-third of persons with hypertension achieve control as defined by national guidelines. Furthermore, racial disparities in hypertension have been clearly documented with African American patients being less likely than Caucasians to achieve adequate control. The objective of this study is to study the implementation of a multi-method quality improvement intervention in a pragmatic clinical trial. Six clinic sites within the Johns Hopkins Community Physicians (JHCP) healthcare system have been selected for participation in this study. The sites are located within the metropolitan ara of Baltimore, Maryland, yet differ greatly. We will define the context and local characteristics of each study site and determine which characteristics are associated with blood pressure control and racial disparity at the clinic (micro-system) and health system (macro-system)level. We will deploy a three-part quality improvement intervention to 1) improve the clinic-based measurement of blood pressure, 2) introduce a care management system to promote patients' self-management behaviors and rapidly titrate medications by algorithms developed in accord with guidelines and 3) introduce an interactive, needs-based, longitudinal-provider education system that promotes patient-centered care and provides practical examples of patient-provider communication strategies. Using statistical process control charting, we will determine the stability of blood pressure control in the system prior to intervention and after the introduction of each intervention. We will vary the order of the interventions among the six clinical sites to determine if each intervention is independently effective in each local context and if the effect is repeatable in other contextual situations within the same macro-system. In addition, we will study the organizational characteristics and features of the local context that are associated with implementation, uptake of the interventions and success of each intervention in achieving blood pressure control and reducing racial disparities in blood pressure control at the clinic level .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • patients with an ICD9 diagnosis of hypertension or a BP >=120/>=80 who have not been seen in the last 12 months and any patient with their most recent BP >=140/>=90 or >=130/>=80 if they have diabetes mellitus or chronic kidney disease

排除标准

  • 未提供

研究组 & 干预措施

Behavioral: Introduce care management system in clinics

Experimental

干预措施: Introduce care management system in clinics (Behavioral)

Behavioral: Improve clinic based measurement of blood pressur

Experimental

干预措施: Improve clinic based measurement of blood pressure (Behavioral)

Behavioral: Provider education system to promote patient-cent

Experimental

干预措施: Provider education system to promote patient-centered care (Behavioral)

结局指标

主要结局

Percent of clinic patients with controlled blood pressure and the racial disparity in controlled BP at each clinic.

时间窗: 24 weeks

The percent of clinic patients each week with SBP \< 140 and DBP \< 90, or if patient is diabetic or has CKD then SBP \<130 and DBP \< 80. If no BP measure, patient does not meet JNC-7 guidelines. Note: If multiple BP measures are recorded, the lowest will be used. The racial disparity is defined as the percent difference in blood pressure control between white patients and ethnic minority patients (separated into categories of African-American patients and other race patients). These outcomes will be assessed weekly for 24 weeks prior to and after roll out of each of the interventions.

次要结局

  • Terminal digit preference(24 weeks)
  • Repeat BP measures(24 weeks)
  • Patient enrollment in care management(24 weeks)
  • Completion of care management program(24 weeks)
  • Dashboard review/communication skills training completion(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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