Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patients Reporting Primary Care Follow-up
研究概览
简要总结
To explore in a pilot randomized clinical trial, the impact of Home Blood Pressure Monitoring with patient directed information as compared to usual care on the postoperative management of blood pressure.
详细描述
The intervention and control groups will be defined by, 1) preoperative home blood pressure monitoring with a detailed report sent to the patient, and 2) usual standard of care including a suggestion during the pre-operative clinic appointment to follow up with Primary Care. Both groups will receive a brief questionnaire about their blood pressure treatment and medication adherence. We will examine the rate of primary care follow-up and changes in hypertension treatment at 60 days post-operative, through a telephone call. This information, along with information regarding patient acceptance of the intervention will be used to inform the design of a future clinical trial powered to outcomes, including follow-up visits and blood pressure management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •We propose to recruit patients who present for ambulatory surgery, aged >18 years, with a preoperative blood pressure > 140/90 mmHg taken as the mean of two readings during the pre-admission testing visit.
排除标准
- •Patients who are unable or unwilling to be contacted by telephone, are non-English speaking, or are unable to operate an automated home blood pressure monitor will also be excluded.
- •Healthy patients with blood pressure readings that fall within the American Heart Association (AHA) guidelines.
研究组 & 干预措施
High Blood Pressure Monitoring and Counseling
Enrolled patients will be fitted with a HBPM device and instructed in its use. Patients will be asked to return the HBPM device on the morning of surgery. At the same time they receive the HBPM device, they will also be provided with the National Institutes of Health (NIH) booklet called "Your guide on lowering blood pressure", which has several guidelines regarding diet, exercise and lifestyle changes that can be implemented to improve blood pressure control.
干预措施: High Blood Pressure Monitor (Device)
Usual Care
The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines. They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.
干预措施: Usual Care (Procedure)
结局指标
主要结局
Patients Reporting Primary Care Follow-up
时间窗: 60 days
For the primary analysis, we will estimate the proportion of subjects that had a primary care follow-up visit within 60 days
Patients Reporting New/Adjusted Hypertension Treatment.
时间窗: 60 days
For the primary analysis, we will estimate the proportion reporting new/adjusted hypertension treatment within 60 days. The count of participants is the number of patients for whom it was determined that they had new or adjusted hypertension treatment.
次要结局
- Patient Acceptance/Satisfaction With Blood Pressure Care(60 days)