Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk: a Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Emergency Department (ED) Visits and Readmissions
研究概览
简要总结
The goal of this educational clinical trial is to identify high-need women most at risk for poor outcomes following delivery, the problems they experience, and to create a system to improve quality of postpartum care for these high-need patients.
The main question[s] it aims to answer are:
- How can the investigators help postpartum patients who have poor outcomes by decreasing the number of ED visits/readmissions for these patients within the first 30 days postpartum?
- How can the investigators increase the ability of participants to "obtain needed services" and ability for patients to see their provider when they need to, in the 30-day post discharge period as one of the main pathways of unnecessary ED visits?
Participants will be put into the study group or control group. The study group will receive a pamphlet postpartum with helpful information as well as a patient navigator who the participants will be able to reach out to their first 30 days postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postpartum patients who have delivered a baby at the Hospital of University of Pennsylvania
- •Ages 18 or older
- •Self-identify as Black (listed on chart)
- •Speak English
- •Able to read
- •Other characteristics defined by our risk prediction model (algorithm)
排除标准
- •Unable to provide informed consent
- •Speaks a language other than English
研究组 & 干预措施
Patient Education Pamphlet and Partner Sheet
The study intervention consists of a patient education pamphlet and partner sheet (physically and virtually accessible) that will educate and prepare post-partum participants about health conditions (hypertension, diabetes, and depression), important health behaviors , physical and emotional postpartum symptoms, teach self-management skills, enhance social support, and connect post-partum participants with community resources. The education materials will provide simple actions that participants can utilize to address symptoms, realistic time frames for healing, danger signs to look out for and contact their physicians, and a list of resources for specific issues. The patient navigator will spend approximately 20 minutes with participants after enrollment, in the hospital. Following discharge, the patient navigator will contact each patient between 4 and 20 times, by phone and/or text with a research phone, to address questions and link participants to medical and community resources.
干预措施: HOME (Behavioral)
Standard Postpartum Care
These patients will receive Standard postpartum care.
结局指标
主要结局
Emergency Department (ED) Visits and Readmissions
时间窗: 1-30 days postpartum
To obtain data for the primary outcome of postpartum morbidity and mortality as measured by Emergency Department (ED) visits and hospital readmissions in the 30-day post discharge period. Investigators will use chart reviews to obtain this ED/Readmission information.
次要结局
- Ability to Obtain Needed Services(1-30 days postpartum)
- Depressive Symptoms(1 day-6 months postpartum)
研究者
Elizabeth Howell
Chair, Department of Obstetrics & Gynecology, Perelman School of Medicine
University of Pennsylvania