Comparative Evaluation of Telehealth Multi-Component Optional Model (MOM) of Postpartum Care Among Rural, Low-income, and Diverse Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 6
- 主要终点
- Completion of post-partum 6-week comprehensive visit
研究概览
简要总结
The aim of this study is to conduct a comparative effectiveness evaluation using a randomized control trail design among diverse women to compare two postpartum care models: 1) Telehealth Multicomponent Optimal Model (Telehealth MOM) and 2) enhanced standard of care (ESoC). This study will address critical gaps in knowledge about how best to deliver comprehensive postpartum care that ensures timely identification and treatment of complications and meets the needs and preferences of diverse patients, including disproportionately-impacted racial groups and rural residents.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women between 16-35 weeks gestation
- •Age 18-44 years
- •Ability to speak English, Spanish, or Marshallese
- •Participants may have either a vaginal birth or cesarean section birth
排除标准
- •Type 1 diabetes on an insulin pump followed closely by endocrinology
- •Uncontrolled Type 2 diabetes
- •End stage renal disease followed closely by nephrology
- •ICU admission at any point during pregnancy or delivery hospitalization
- •Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy/appendectomy)
- •Incarceration
- •Mental disability limiting decision-making capacity
- •Uncontrolled chronic hypertension
- •HELLP syndrome during pregnancy
- •Sickle cell disease
- •Maternal heart condition or heart disease
- •Opioid use disorder
- •Thrombophilia or blood clots
- •Need for blood transfusion during delivery hospitalization
- •Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum
研究组 & 干预措施
Telehealth MOM
Telehealth MOM. Each patient will receive ESoC which includes: education on the symptoms to watch for and when to call their healthcare provider, an in-person comprehensive postpartum visit around 6 weeks postpartum, and any additional care deemed necessary by their health care providers. Patients in the Telehealth MOM arm will be also provided with a remote monitoring blood pressure cuff and thermometer and will be instructed to take their blood pressure and temperature twice a day for 14 days after discharge from the hospital. A Registered Nurse will monitor blood pressure and temperature readings over the 14-day period and will contact the patient if the readings are out of range to discuss symptoms and the recommend a course of action. A Registered Nurse will conduct an early postpartum telehealth visit between 10-14 days postpartum.
干预措施: Telehealth MOM (Behavioral)
Enhanced Standard of Care
Enhanced standard of care (ESoC). Each patient will be provided education on the symptoms to watch for and when to call their healthcare provider. Patients will be scheduled for a comprehensive postpartum visit around 6 weeks postpartum and any additional care deemed necessary by their health care providers.
干预措施: Enhanced Standard of Care (Other)
结局指标
主要结局
Completion of post-partum 6-week comprehensive visit
时间窗: Baseline to 6 weeks post-partum
Binary measure (yes/no) of visit completion
次要结局
未报告次要终点