Community Health Worker Assessment for Postpartum Health (CAREPATH)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
研究概览
简要总结
The goal of this randomized controlled trial is to compare the CAREPATH intervention with standard of care on postpartum outcomes among up to 500 postpartum individuals. The CAREPATH includes 3 postpartum telehealth visits from a perinatal CHW.
The study will address the following aims:
Aim 1: Compare: A) CARE PATH and B) standard of care among postpartum individuals on:
Aim 1.A: postpartum visit completion.
- Hypothesis 1.A: Patients assigned to the CARE PATH will have higher completion of their postpartum visit compared to those receiving standard of care.
Aim 1.B: early detection of postpartum complications.
- Hypothesis 1.B: Patients assigned to the CARE PATH will be more likely to experience early detection of postpartum complications that arise compared to those receiving standard of care.
Aim 1.C: hospital readmission and ED visits postpartum.
- Hypothesis 1.C: Patients assigned to the CARE PATH will be less likely to have hospital readmission or an ED visit compared to those receiving standard of care.
Aim 2: Explore the impact of A) CARE PATH and B) standard of care on reproductive life planning/contraceptive counseling.
- Hypothesis 2: Patients assigned to the CARE PATH will be more likely to report reproductive life planning/contraceptive counseling.
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
- 16 Years 至 44 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 16-44 years old
- •≤ 38 weeks pregnant
- •Ability to speak English, Spanish or Marshallese
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
- •Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum
研究组 & 干预措施
Standard of Care (SoC)
Participants in the SoC arm will receive education on symptoms of postpartum complications and assistance scheduling their postpartum visit with their healthcare provider.
干预措施: Standard of Care (Other)
CAREPATH
Participants in the CAREPATH arm will receive standard of care plus three telehealth visits from a perinatal community health worker during the first six weeks of the postpartum period. During the visits, participants will be screened for postpartum complications using a symptom monitoring checklist that covers urgent maternal warning signs, as well as anxiety and depression.
干预措施: CAREPATH (Behavioral)