A Remote Postpartum (PP) Blood Pressure Surveillance and Reminder System for Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Blood Pressure (BP) Surveillance Adherence
研究概览
简要总结
The purpose of this study is to trial remote patient monitoring (RPM) in the postpartum hypertensive population in a randomized control design, with an aim to increase the number of blood pressure measurements taken during the fragile and under-monitored postpartum period and to thereby improve postpartum blood pressure control and reduce severe morbidity and mortality. The investigators plan to compare the number of blood pressures recorded in the first 10 days postpartum between patients who have been enrolled in an RPM trial to those who are being treated with the usual care.
详细描述
Many women develop high blood pressure as a complication of pregnancy. This high blood pressure can often take many weeks to resolve, and for some women it never resolves completely. If untreated, high blood pressure of pregnancy can lead to serious consequences, such as seizure or stroke. Unfortunately, because most women are sent home from the hospital just 2-3 days after having a baby, the best way of monitoring blood pressure at home is still unknown. Most women are given a prescription for a blood pressure cuff to use at home and an appointment to see their doctor at about one week after delivery to review their blood pressures, but many women have trouble checking their blood pressures, sometimes because they have a new baby at home and sometimes for other reasons like transportation or difficult social situations. Using a Bluetooth blood pressure monitoring system might help women have better blood pressure monitoring after they are discharged from the hospital after delivery, and therefore help to prevent some of the complications that can happen because of high blood pressure related to pregnancy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postpartum women
- •Previous diagnosis of chronic hypertension, or antepartum diagnosis of hypertensive disorder of pregnancy (defined as documented blood pressure of ≥140 systolic or ≥90 diastolic on at least 2 occasions at least 4 hours apart)
- •At least 18 years of age
- •English or Spanish speakers
排除标准
- •Non-English or Spanish speakers
- •Women who are not planning on obtaining their postpartum follow up at CUIMC
- •Women who are physically unable to hold or use the tablet
- •Women who do not have a working phone
- •Provider unwilling or unable to set up escalation pathway
- •Women who reside outside of New York State
- •Hypertension diagnosed postpartum
研究组 & 干预措施
Usual Care
Usual care group patients will be assigned to the usual care given to patients with hypertensive disorders of pregnancy at Columbia University Irving Medical Center (CUIMC). This involves a prescription for a blood pressure cuff if they do not already have one, with which they will be asked to measure their blood pressure twice per day. They will be asked to keep a log of their blood pressure measurements and to bring that log to their next provider visit.
Remote Patient Monitoring
Remote Patient Monitoring patients will use a Bluetooth-enabled blood pressure cuff, which will transmit blood pressure measurements via Bluetooth from the monitor to a tablet, which is able to be accessed by nurses staffing a remote clinical care center. Patients will also be prompted to answer surveys assessing symptoms of preeclampsia. The nurses will review measurements and survey results, which will be flagged in order of urgency. The measurements uploaded into the remote monitoring system will also be reviewed at the patient's next provider visit.
干预措施: Remote Patient Monitoring (Device)
结局指标
主要结局
Blood Pressure (BP) Surveillance Adherence
时间窗: Up to 14 days from delivery hospitalization discharge
Percentage of recommended twice-daily blood pressures reported between hospital discharge and first outpatient blood pressure assessment
次要结局
- Communications(Up to 14 days post delivery hospitalization discharge)
- Total Percentage of Elevated Blood Pressure Readings(Up to 14 days from delivery hospitalization discharge)
- Number of Participants With Outpatient BP Assessment Within 14 Days(Up to 14 days from delivery hospitalization discharge)
- Percentage of Participants With Elevated BP After Discharge(Up to 14 days from delivery hospitalization discharge)
- Number of Participants With Outpatient PP Assessment(Up to 8 weeks from delivery)
- Percentage of Participants With Elevated Blood Pressure at the Postpartum Visit(Up to 8 weeks from delivery)
- Time to Medication Initiation(Up to 8 weeks from delivery)
- Number of Participants Readmitted(Up to 8 weeks from delivery)
- Number of Participants Initiated on Antihypertensive Therapy After Hospital Discharge(Up to 8 weeks from delivery)
- Number of Participants With ED Visit(Up to 8 weeks from delivery)
- Number of Participants Who Developed Preeclampsia-associated Complications(Up to 8 weeks from delivery)
- Number of Participants Referred to Primary Care for Continued Blood Pressure Management(Up to 8 weeks from delivery)
- Score on the Modified Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)(Up to 8 weeks from delivery)
- Score on the Philips Program Start Survey and the Philips Program End Survey(Baseline, program end (up to 8 weeks from delivery))