UCSF BP Activate Letter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 484
- 试验地点
- 2
- 主要终点
- Time to medication change or demonstrated BP control at 6 months
研究概览
简要总结
The BP Activate Study aims to assess the effectiveness of the BP Report letter with personalized BP medication recommendations, compared with Control letters and no intervention, at shortening time to appointment, time to visit, time to medication change, and time to achievement of BP goal.
详细描述
The BP Activate Study is a randomized quality improvement trial. We will deliver one of two versions of a letter to established English-speaking primary care patients at Mt Zion with uncontrolled hypertension, defined by SBP>140 or DBP>90 in the past two years (identified via EHR). The letter will prompt patients to schedule a visit with their provider or team nurse practitioner to discuss their BP recommendations with their clinician. We will test 2 versions of the letter and a usual care control:
- The "BP Activate Report Letter" group will get a letter that presents recommendations for medication changes from a computerized algorithm using the patient's medical records and recommends discussing these specific recommendations with their clinician; or
- The "Control Letter" group will get a letter that suggests they talk to their clinician about their BP without providing any specific medication recommendations.
- The "Usual Care" group will not receive any intervention.
This primary goal of the study is to assess the effectiveness of the BP Activate Report Letter compared with the Control Letter, and see if it shortens time to appointment, time to visit, time to medication change (primary outcome), and time to achievement of BP goal. Clinicians, with patient input, will still have full control of how BP is clinically managed. A small number of patients will be contacted by a research coordinator to hear what they thought when they received the letter, and why they did or did not act upon the information.
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
- 否
入选标准
- •Patient is a primary care patient of a clinician in a general internal medicine clinic who has agreed to have their patients participate in the study
- •Lowest SBP>140 or lowest DBP>90 at last visit in general internal medicine clinic
- •Last visit in general internal medicine clinic was < 2 years ago
- •EngageRx algorithm determines that a medication intensification step is indicated
排除标准
- •Primary language is not English
- •Patient's provider indicates (through an active opt-out process) that they do not want the patient to receive a BP Activate letter
结局指标
主要结局
Time to medication change or demonstrated BP control at 6 months
时间窗: 6 months
Time is measured as number of days between randomization date and the day that a participant is prescribed a new anti-HTN medication or an increase in dose of a prior anti-HTN medication, or they have a documented BP measurement \<140 mmHg systolic and \<90 mmHg diastolic.
次要结局
- Time to BP goal at 3 months(3 months)
- Time to medication change at 6 months(6 months)
- Time to completed visit at 3 months(3 months)
- Time to medication change at 3 months(3 months)
- Time to completed visit at 6 months(6 months)
- Time to medication change or demonstrated BP control at 3 months(3 months)
- Time to BP goal at 6 months(6 months)