Melanated Group Midwifery Care (MGMC)
- Conditions
- Maternal Care PatternsPregnancy ComplicationsPatient Engagement
- Interventions
- Behavioral: Melanated Group Midwifery Care
- Registration Number
- NCT05365815
- Lead Sponsor
- University of Illinois at Chicago
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 432
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MGMC Intervention Group Melanated Group Midwifery Care 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.
- Primary Outcome Measures
Name Time Method Patient Engagement-Postnatal adequacy 1 year postpartum (T6) Appropriate number (yes/no) and timing of postnatal visits (yes/no) documented in electronic medical record
Patient Engagement-Prenatal Adequacy Birth (T3) Appropriate number (yes/no) and timing of prenatal visits (yes/no) documented in electronic medical records
Patient Engagement-Prenatal Adherence Birth (T3) Five tests completed during prenatal period (yes/no), documented in electronic medical record
- Secondary Outcome Measures
Name Time Method Provider Trust Change from baseline through 12 months postpartum (T6) Trust in Physician Scale, 11 items, range 11-55, Likert 1-5; α =0.85-0.90.
Patient Satisfaction Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4) 22 items; 5-point Likert (excellent to poor); α =0.95. Excellent reliability and construct validity, taps six established dimensions of satisfaction (art of care, technical quality, access, physical environment, availability, and efficacy)
Patient activation Change from baseline through 12 months postpartum (T6) Patient Activation Measure (PAM), 13-item scale, range 0-100, Likert disagree strongly to agree strongly and not applicable. Assesses degree to which individuals take an active role in managing health and health care. Higher scores are more likely to understand that their active involvement is critical to their state of health and considered more ''in charge.'' The PAM has strong psychometric properties and is predictive of a wide range of health-related behaviors. Hibbard et al. report that a 4-point difference in PAM scores can be viewed as clinically significant.
Patient Autonomy Change from baseline through 12 months postpartum (T6) Mothers Autonomy in Decision-Making Scale. 7 item scale, Likert completely disagree to completely agree. Assesses the degree to which patients were given decision-making for healthcare decisions, and if patients felt respected by providers. Higher scores indicate that providers supported patient autonomy and patient decision-making.
Mental Well Being Change from baseline through 12 months postpartum (T6) Computerized Adaptive Testing - Mental Health: assessing depression, anxiety, suicidality, substance use disorder, and social determinants of health.
Respectful Care Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4) Mothers on Respect index (MORi) quantifies women's sense of disrespect and dismissal when engaging in conversation with providers, 14 items, Likert, ranging from 1-strongly disagree to 6-strongly agree. α =0.94
Trial Locations
- Locations (1)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States