Implementation Models for Blood Pressure Monitoring in Pregnancy and Postpartum: Connected MOM Plus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Successful use of the intervention and control programs measured by enrollment aggregate
研究概览
简要总结
Quality improvement (QI) initiative to improve uptake and utilization of Connected MOM, particularly among those with limited access to health care
详细描述
Study outcomes include: 1) To determine whether providing enhanced support and coaching to support Connected MOM use increases use among those who stand to benefit; 2) To determine whether Connected MOM and healthcare resources are more appropriately used with provision of additional support; and 3) To determine whether the enhancement of support for the Connected MOM program improves maternal and infant health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistician
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Access to a smartphone
- •Understanding of English or Spanish in oral and written discourses
- •Have a participating Ochsner-employed provider
- •Plan to deliver at a participating Ochsner hospital
- •Reside in a zip code served by the participating clinics
排除标准
- •Provider feels that study participation is not in patient's best interest
- •Does not understand English or Spanish well enough to follow recommendations
- •Plans to move from the study area served by the participating clinics
研究组 & 干预措施
Intervention - CM+
Navigator support to enroll and use Connected MOM
干预措施: Connected MOM + (Other)
Control - CM
Standard protocol for offering Connected MOM
结局指标
主要结局
Successful use of the intervention and control programs measured by enrollment aggregate
时间窗: 6-9 months
Aggregate enrollment in the intervention or control arms by 25 weeks of gestation relative to the total number of eligible participants. This will be measured by the total number of women participating in the Connected MOM or Connected MOM+ divided by the total number of eligible pregnant women presenting to the hospital.
Successful use of the intervention and control programs as determined by the systolic and diastolic blood pressure measurements
时间窗: 6-9 months
This is determined by measuring the systolic and diastolic blood pressure in mmHg at least once per week during pregnancy.
Successful use of the intervention and control programs as determined by postpartum blood pressure measurement
时间窗: 6-9 months
This is determined by measuring at least one postpartum blood pressure measurement (systolic and diastolic) in mmHg before a postpartum visit.
Adequacy of prenatal care
时间窗: 6-9 months
Adequacy of prenatal care will be measured using the Kotelchuck index, a score that assesses the adequacy of maternal health care. The score ranges from 0% to above, with higher scores indicating better maternal health care.
Adverse composite maternal outcome
时间窗: 6-9 months
pre-eclampsia without severe features (\~5%), pre-eclampsia with severe features (1-2%), HELLP syndrome; eclampsia (rare), preterm delivery \< 37 weeks (spontaneous or indicated) (12-15%), SMM without transfusion included (around 2-3%), maternal mortality
次要结局
- Reach(6-9 months)
- Sustainability(6-9 months)
- Engagement(6-9 months)
- Retention(6-9 months)
- Attendance of a postpartum visit(6-9 months)