Improving Blood Pressure Control in Diverse Populations by Measuring Accurately, Acting Rapidly, and Partnering With Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,238,835
- 试验地点
- 48
- 主要终点
- Change in Blood Pressure Control, % of Patients
研究概览
简要总结
BP-MAP is a cluster randomized controlled trial (RCT) designed to compare the effectiveness of BP lowering from a clinic-based quality improvement program with Full Support (dedicated practice facilitation) vs. a Self-Guided version of the program. The American Medical Association (AMA) developed the framework for the interventions.
详细描述
BP-MAP is a cluster randomized controlled trial (RCT) designed to compare the effectiveness of BP lowering from a clinic-based quality improvement program with Full Support (dedicated practice facilitation) vs. a Self-Guided version of the program. The American Medical Association (AMA) developed the framework for the interventions. The trial will be conducted within the National Patient-Centered Clinical Research Network (PCORnet) that enables distributed querying of electronic health record data in a common data model. The primary outcome will be change in clinic-level blood pressure (BP) control at 6 months. Secondary outcomes will include other blood pressure (BP) control metrics, other time points (12 and 18 months), and process measures such as BP measurement accuracy, medication intensification, and average systolic blood pressure (SBP) reduction after a medication intensification, and repeat visit within 4 weeks after a visit with elevated BP. The investigators hypothesize clinics randomized to the Full Support version will achieve a larger increase from baseline in the proportion of their hypertensive patients with controlled BP at 6 months as compared to clinics randomized to the Self-Guided version, and also as compared with usual care. The investigators will also conduct non-randomized comparisons of BP control in the Full Support and Self-Guided intervention arms to BP control in non-participating "Usual Care" institutions in PCORnet. This study was submitted to the IRB at UCSF, determined to be quality improvement and exempt from further review.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Blood Pressure Control, % of Patients
时间窗: baseline and 6 months
The primary outcome will be clinic-level change in the proportion of patients with controlled BP from baseline to 6 months after the start of the intervention. BP control will be defined according to NQF 0018 as the percent of eligible patients (defined below) with SBP \<140 mmHg and DBP \< 90 mmHg, based on measurements obtained at the most recent ambulatory clinical encounter at baseline (using the lowest measures of SBP and DBP at that encounter) and similarly at the 6-month time point after initiation of the intervention.
次要结局
- Change in Average Systolic Blood Pressure (SBP) Reduction After a Medication Intensification Visit, mmHg(baseline and 6 months)
- Change in Repeat Visit in 4 Weeks After a Visit With Elevated BP, % of Visits(baseline and 6 months)
- Change in Use of Fixed Dose Combination Product Among Patients Taking 2 or More Classes of Medications, % of Patients(baseline and 6 months)
- Change in Use of a CCB or Thiazide or Thiazide-like Diuretic Among African-American Patients on at Least One Medication, % of Patients(baseline and 6 months)
- Change in Terminal Digit = Zero, % of Measurements(baseline and 6 months)
- Change in Blood Pressure Controlled to 2017 Guideline Goal, % of Patients(baseline and 6 months)
- Change in Improvement in Blood Pressure, % of Patients(baseline and 12 months)
- Change in Confirmatory Repeated Blood Pressure Measurement, % of Visits(baseline and 6 months)
- Change in Medication Intensification, % of Visits(baseline and 6 months)