Melanated Group Midwifery Care (MGMC)

Study Overview
=================
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.

Official Title
-----------------
Black Midwives for Black Women: Maternity Care to Improve Trust and Attenuate Structural Racism

Conditions
-----------------
Pregnancy Complications, Maternal Care Patterns, Patient Engagement

Intervention / Treatment
-----------------
* Behavioral: Melanated Group Midwifery Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria 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. Exclusion criteria 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.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MGMC Intervention Group<br>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. | Behavioral: Melanated Group Midwifery Care<br>* Racially concordant maternity care Group prenatal care Racially concordant nursing care coordination Postpartum doula support<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Engagement-Prenatal Adequacy | Appropriate number (yes/no) and timing of prenatal visits (yes/no) documented in electronic medical records | Birth (T3) | 
| Patient Engagement-Prenatal Adherence | Five tests completed during prenatal period (yes/no), documented in electronic medical record | Birth (T3) | 
| Patient Engagement-Postnatal adequacy | Appropriate number (yes/no) and timing of postnatal visits (yes/no) documented in electronic medical record | 1 year postpartum (T6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient activation | 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. | Change from baseline through 12 months postpartum (T6) | 
| Patient Autonomy | 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. | Change from baseline through 12 months postpartum (T6) | 
| Provider Trust | Trust in Physician Scale, 11 items, range 11-55, Likert 1-5; α =0.85-0.90. | Change from baseline through 12 months postpartum (T6) | 
| Patient Satisfaction | 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) | Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4) | 
| Mental Well Being | Computerized Adaptive Testing - Mental Health: assessing depression, anxiety, suicidality, substance use disorder, and social determinants of health. | Change from baseline through 12 months postpartum (T6) | 
| Respectful Care | 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 | Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4) |