Minding the Gap: Improving Women's Health Through Coordinated Postpartum Planning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Number of Participants Attending a Comprehensive Postpartum Visit
研究概览
简要总结
The purpose of the study is to design, implement, and evaluate a holistic postpartum women's health care system for women who have cardiovascular risk factors for severe maternal morbidity (SMM) including chronic hypertension, chronic diabetes, gestational diabetes, pre-pregnancy obesity, or a hypertensive disorder of pregnancy (HDP) which includes gestational hypertension or preeclampsia. The researchers will use a sequential mixed methods design. First, the researchers will conduct in-depth interviews with women who have given birth in the prior year to characterize barriers and facilitators to accessing postpartum care. The information from these interviews will be used to inform the design of a postpartum care system. Next, the researchers will conduct a pragmatic randomized trial to test the effectiveness of the system on postpartum care engagement versus standard of care.
详细描述
The US maternal mortality ratio is the highest among developed nations at 26.4 maternal deaths per 100,000 live births. Among the states, Georgia has the second highest maternal mortality (66.3 per 100,000), with a 60% higher rate for black vs white women (95.6 vs 59.7 per 100,000). Nearly 100 times more common than maternal mortality is severe maternal morbidity (SMM), defined as unexpected outcomes of labor and delivery that result in short- and long-term deleterious health consequences. Maternal mortality and SMM are highest among women who are black, publicly insured or uninsured, and deliver in safety-net hospitals. In Georgia, 66% of maternal deaths occur to women insured by Medicaid at delivery and the majority of deaths and SMM occur postpartum, a time during which healthcare visits are poorly attended and oftentimes inaccessible. The Georgia Maternal Mortality Review Committee concluded that two-thirds of maternal deaths are preventable, with chronic health conditions, obesity, delays in accessing and fragmentation of care as key contributors. As solutions, it recommends improved prenatal and postpartum follow-up and case management, control of chronic health conditions, and extension of Medicaid coverage beyond 60 days postpartum.
While the postpartum period represents a crucial window of opportunity for promoting women's current and future health, up to 40% of US women do not attend postpartum visits due to structural barriers (e.g., lack of insurance, transportation or childcare) social barriers (e.g., medical mistrust and poor patient-provider relationships) or low perceived utility of postpartum care. Moreover, the lowest rates of postpartum care utilization are concentrated among women with the highest rates of pregnancy complications and chronic conditions (e.g., women who are uninsured or Medicaid-insured, low-income, and non-Hispanic black). Timely and adequate use of postpartum care is especially important for women with diabetes or hypertensive disease as these conditions are associated with increased risk for postpartum morbidity and mortality and cardiovascular disease later in life.
The researchers of this study plan to conduct an intervention study to assess the effect of a woman-centered, comprehensive postpartum care system on postpartum visit attendance and follow-up care among medically underserved women with chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity or hypertensive disorder of pregnancy (HDP). Because implementing and sustaining a comprehensive postpartum care system in a health disparities population requires a thorough understanding of patient preferences regarding the structural and process elements of care, methods of provider-patient communication, and strategies for addressing social and contextual barriers to care the researchers will use in-depth interviews to inform the intervention design and then assess health outcomes and satisfaction.
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
Information on all outpatient visits occurring between delivery discharge and 12 weeks postpartum will be abstracted and blinded for review. Two independent physicians will review the blinded information and determine whether the visit meets the criteria for a comprehensive postpartum visit.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women between 20-34 weeks of gestation
- •have received 1 or more prenatal care visits at Grady Memorial Hospital in Atlanta, Georgia (GA)
- •intend to deliver at Grady Memorial Hospital
- •speak English or Spanish
- •have a diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity (body mass index [BMI] of 30 or greater), and/or a hypertensive disorder of pregnancy (gestational hypertension or preeclampsia) documented in the electronic medical record (EMR)
排除标准
- •adults unable to consent, infants, and prisoners
研究组 & 干预措施
Enhanced Postpartum Care System
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity who are randomized to receive enhanced postpartum care.
干预措施: Enhanced Postpartum Care System (Behavioral)
Standard of Care
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity who are randomized to receive standard postpartum care.
结局指标
主要结局
Number of Participants Attending a Comprehensive Postpartum Visit
时间窗: 12 weeks after delivery
The postpartum visit occurs between 4 and 12 weeks after delivery and is defined as a preventive care visit with an obstetric care provider (e.g., obstetrician-gynecologist, certified nurse midwife, or primary care provider with additional training relevant to postpartum care) that included an assessment of assessing multiple aspects of physical and mental health. Comprehensive postpartum visit attendance was identified using data from medical records using a standardized abstraction form.
次要结局
- Number of Participants Receiving Postpartum Hypertension Screening(12 weeks after delivery)
- Perceived Risk of Severe Maternal Morbidity (SMM)(12 weeks after delivery)
- Number of Participants Using Medication(12 weeks after delivery, 14 months after delivery)
- Number of Participants Readmitted to the Hospital(12 weeks after delivery, 14 months after delivery)
- Perceived Risk of Cardiovascular Disease(12 weeks after delivery, 14 months after delivery)
- Number of Participants Using Contraception(12 weeks after delivery, 14 months after delivery)
- Number of Participants Attending Any Postpartum Visit(12 weeks after delivery)
- Number of Participants for Whom Postpartum Diabetes Screening Was Ordered(12 weeks after delivery)
- Number of Participants for Whom Postpartum Diabetes Screening Was Performed(12 weeks after delivery)
- Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered(12 weeks after delivery)
- Number of Participants With Diabetes for Whom Postpartum Screening Was Performed(12 weeks after delivery)
- Number of Participants Receiving Postpartum Hypertension Screening(12 weeks after delivery)
- Number of Participants With Hypertension Receiving Postpartum Hypertension Screening(12 weeks after delivery)
- Number of Participants Using Contraception 12 Weeks After Delivery(12 weeks after delivery)
- Number of Participants Using Contraception 14 Months After Delivery(14 months after delivery)
- Number of Participants Using Medication 12 Weeks After Delivery(12 weeks after delivery)
- Number of Participants Using Medication 14 Months After Delivery(14 months after delivery)
- Number of Participants With Ongoing Pregnancy Complications at 12 Weeks After Delivery(12 weeks after delivery)
- Number of Participants With Ongoing Pregnancy Complications at 14 Months After Delivery(14 months after delivery)
- Number of Participants Readmitted to the Hospital at 12 Weeks After Delivery(12 weeks after delivery)
- Number of Participants Readmitted to the Hospital at 14 Months After Delivery(14 months after delivery)
- Perceived Risk of Severe Maternal Morbidity (SMM)(12 weeks after delivery)
- Perceived Risk of Cardiovascular Disease at 12 Weeks After Delivery(12 weeks after delivery)
- Perceived Risk of Cardiovascular Disease at 14 Month After Delivery(14 months after delivery)
- Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 12 Weeks After Delivery(12 weeks after delivery)
- Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 14 Months After Delivery(14 months after delivery)
- Satisfaction With Postpartum Care(12 weeks after delivery)
- Satisfaction With Provider at Postpartum Care Visit(12 weeks after delivery)
- Number of Participants Using Primary Care(14 months after delivery)
- Number of Participants Using Specialty Care(14 months after delivery)
- Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery(12 weeks after delivery)
- Number of Participants in Self-rated Categories of Postpartum Health at 14 Months After Delivery(14 months after delivery)
研究者
Anne Lang Dunlop
Professor
Emory University