Melanated Group Midwifery Care (MGMC) (MGMC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Patient Engagement; Maternal Care Patterns
• Intervention / Treatment: Behavioral: Melanated Group Midwifery Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 432
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kylea L Liese, PhD; Phone Number: 3129961867; Email: kylea3@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612-7316
      • Recruiting
      • University of Illinois at Chicago
      • Contact: Kylea L Liese, PhD; Phone Number: 312-996-1867; Email: kylea3@uic.edu
      • Contact: Stacie Geller, PhD; Email: sgeller@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Melanated Group Midwifery Care; Racially concordant maternity care Group prenatal care Racially concordant nursing care coordination Postpartum doula support
No Intervention: 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.

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Referrals	Referrals to higher acuity medical or obstetric care	12 months postpartum (T6)
Social Referrals	Referrals to higher acuity mental health or social services	12 months postpartum (T^)

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: Patient-Centered Outcomes Research Institute; University of Chicago
• Investigators: Principal Investigator: Stacie L Geller, PhD, University of Illinois Chicago

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications
• Other Study ID Numbers: CHAIRb 21120101; AD-2020C3-21229 (Other Grant/Funding Number: PCORI Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No