Black Midwives for Black Women: Maternity Care to Improve Trust and Attenuate Structural Racism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Patient Engagement-Postnatal adequacy
研究概览
简要总结
This study is being conducted to determine if a multi-level intervention for delivering maternity care can improve patient trust and engagement among Black birthing people.
详细描述
Low-risk pregnant participants will be randomized into Melanated Group Midwifery Care or usual individualized obstetric care. In Melanated Group Midwifery Care (MGMC), Black women will receive prenatal care from a Black midwife in groups with the same 8-10 other Black women throughout pregnancy. In pregnancy and into the first year postpartum, MGMC patients will stay connected to the health system through a proactive care coordinator, who is a Black licensed nurse. For the first year after giving birth, patients in MGMC will also be supported by a trained postpartum doula.
All participants (intervention and usual care groups) will complete study measures that include validated surveys on patient trust, respect and engagement at 6 time points:
- 3 time points in pregnancy [baseline (<20 weeks), 26-28 weeks, and 35- 37 weeks] and
- 3 in the postpartum at 2-, 6-, and 12-months
- Additional qualitative interviews will be done to track the care received by medically and socially complex patients, including all who experience a severe maternal morbidity.
The investigators will also document how MGMC gets embedded in practice through a qualitative process evaluation.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The research team working on the effectiveness evaluation of group care is blinded to study condition and is charged with collecting the Aim 1 effectiveness data from the individuals.
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for patients:
- •pregnant women who self-identify as Black on a standard prenatal intake form
- •less than 20 weeks pregnant
- •15 years old or older
- •present to the general obstetrics group at the University of Chicago Medical Center for their new prenatal visit
- •speak and understand English
- •Inclusion criteria for providers:
- •All black midwives, care coordinators, and community postpartum doulas at the University of Chicago are eligible to participate.
排除标准
- •for patients:
- •having a condition for which they present to a higher level of obstetrics care (e.g., maternal fetal medicine) for their new prenatal visit
- •having a cognitive issue that impairs their ability to give informed consent.
研究组 & 干预措施
MGMC Intervention Group
In the MGMC (intervention) group, pregnant women will participate in group prenatal care and have ~2-hour visits with the same two co-facilitators, a Black midwife and a Black care coordinator, along with 8-12 other Black women at a similar stage of pregnancy, for all prenatal and one postnatal care visits.
The care coordinator will proactively engage with women throughout pregnancy and up to 12 months postpartum. The care coordinator helps women make appointments, sends reminders, and follows-up to ensure care was received, understood, and was appropriate. In the 3rd trimester, women in MGMC will be introduced to a community-based postpartum doula. The doula will make home visits once before birth and within the first 2 weeks postpartum; they will have approximately 50 contact hours available for 12 months postpartum for primarily in-person support, but they will be available by phone and text.
干预措施: Melanated Group Midwifery Care (Behavioral)
Usual Care
In the usual care (comparator) group, pregnant women attend individually scheduled visits with a midwife or obstetrician for a physical assessment and counseling. Although this can vary by provider, continuity of care is rare and racial concordance is not a consideration. Referrals for medical or social services are given to the patient to complete in both prenatal and postnatal care.
结局指标
主要结局
Patient Engagement-Postnatal adequacy
时间窗: 1 year postpartum (T6)
Appropriate number (yes/no) and timing of postnatal visits (yes/no) documented in electronic medical record
Patient Engagement-Prenatal Adequacy
时间窗: Birth (T3)
Appropriate number (yes/no) and timing of prenatal visits (yes/no) documented in electronic medical records
Patient Engagement-Prenatal Adherence
时间窗: Birth (T3)
Five tests completed during prenatal period (yes/no), documented in electronic medical record
次要结局
- Provider Trust(Change from baseline through 12 months postpartum (T6))
- Patient Satisfaction(Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4))
- Patient activation(Change from baseline through 12 months postpartum (T6))
- Patient Autonomy(Change from baseline through 12 months postpartum (T6))
- Mental Well Being(Change from baseline through 12 months postpartum (T6))
- Respectful Care(Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4))
研究者
Kylea Laina Liese
Assistant Professor
University of Illinois at Chicago