Melanated Group Midwifery Care (MGMC)

Not Applicable

Recruiting

• Conditions: Maternal Care Patterns; Pregnancy Complications; Patient Engagement

• 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.

Study Timeline

• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-09
• Study Start: 2022-06-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2026-05-15
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 432

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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