Systematic Monitoring and Remote Testing of Blood Pressure in Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,602
- 试验地点
- 2
- 主要终点
- Proportion of women monitoring blood pressure (BP) according to American College of Obstetricians and Gynecologists (ACOG) guidelines
研究概览
简要总结
The purpose of this research study is to find out the usefulness of checking a woman's blood pressure remotely (at home) for 3 weeks after being discharged from the hospital after having a baby (or babies). Some women can develop hypertension, or high BP, after delivery even if they have not had this problem before or during their pregnancy. Untreated or unknown high BP can lead to medical complications, and if severe, can be life threatening. Monitoring, or checking, remote BP after a woman has delivered her baby (or babies) has been suggested to be a better way to monitor BPs without having to stay in the hospital for a longer time after delivery. Other researchers report that women who have checked their BP remotely after delivery found out that this was both possible and acceptable.
详细描述
This is a randomized control trial (RCT). All women, 18 years of age and older, delivering an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist and residing in Forsyth County, NC that have been approached by our Home Visit Coordinators will be eligible for enrollment and invited to participate in the SMART- BP study prior to discharge from the postpartum unit. Per established protocols, the Home Visit Coordinators for the Nurse Education Support Team Program attempt to approach all women that deliver in The Birth Center and who reside in Forsyth County. At this initial introduction, the Home Visit Coordinators determine if the patient has any need for, or interest in, any of the vetted community resources available to her and her family. Information about any of these resources are provided to the patient at that time. Additionally, the Home Visit Coordinators offer to schedule a nurse "home visit". This nurse home visit occurs via phone call, telehealth visit, or an in person visit ~2 weeks after delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Women that received prenatal care at one of the Atrium Health Wake Forest Baptist OB/MFM outpatient clinic locations in Forsyth County, NC
- •Women that delivered an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist
- •Women that delivered an infant(s) at home or outside facility, and were transported to Atrium Health Wake Forest Baptist and received postpartum care in The Birth Center
- •Currently resides in Forsyth County, NC
- •18 years of age or older
- •Able to read and understand either English or Spanish
- •Owns or has daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan
排除标准
- •Women that received postpartum care at any location other than The Birth Center at Atrium Health Wake Forest Baptist
- •Resides outside of Forsyth County, NC
- •Under 18 years of age
- •Unable to read or understand either English or Spanish
- •Does not own or have daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan
结局指标
主要结局
Proportion of women monitoring blood pressure (BP) according to American College of Obstetricians and Gynecologists (ACOG) guidelines
时间窗: Day 10 postpartum
Impact of rBPM on adherence to ACOG recommendations
Median total cost of health care
时间窗: From discharge through week 8 postpartum
Median number of Severe Hypertension events
时间窗: Discharge through week 3 postpartum
Median number of encounters for urgent or emergent care
时间窗: Discharge through week 3 postpartum
Study team will use the electronic health record to identify encounters to the Emergency Department, OB Triage, and Urgent Care facilities
Median number of rBPM measures obtained
时间窗: Discharge through Week 3 postpartum
Used to determine feasibility of remote blood pressure monitoring intervention (rBPM)
次要结局
- Median number of hospital readmissions(Discharge through week 8 postpartum)
- Median Length of Stay (LOS) for hospital readmissions(Discharge through week 8 postpartum)
- Median Length of Stay (LOS) in hospital after delivery(Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum)
- Median number of encounters for urgent or emergent care(Discharge through week 8 postpartum)
- Acceptability of rBPM in postpartum period(Week 3 postpartum)
- Median number of women that have a follow-up encounter scheduled with their Primary Care Physician (PCP) within 12 months after delivery(Discharge through 12 months postpartum)