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Melanated Group Midwifery Care (MGMC) (MGMC)

Primary Purpose

Pregnancy Complications, Maternal Care Patterns, Patient Engagement

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melanated Group Midwifery Care
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pregnancy Complications

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Illinois at ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MGMC Intervention Group

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Patient Engagement-Prenatal Adequacy
Appropriate number (yes/no) and timing of prenatal visits (yes/no) documented in electronic medical records
Patient Engagement-Prenatal Adherence
Five tests completed during prenatal period (yes/no), documented in electronic medical record
Patient Engagement-Postnatal adequacy
Appropriate number (yes/no) and timing of postnatal visits (yes/no) documented in electronic medical record

Secondary Outcome Measures

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.
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.
Provider Trust
Trust in Physician Scale, 11 items, range 11-55, Likert 1-5; α =0.85-0.90.
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)
Mental Well Being
Computerized Adaptive Testing - Mental Health: assessing depression, anxiety, suicidality, substance use disorder, and social determinants of health.
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

Full Information

First Posted
April 26, 2022
Last Updated
May 9, 2023
Sponsor
University of Illinois at Chicago
Collaborators
Patient-Centered Outcomes Research Institute, University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05365815
Brief Title
Melanated Group Midwifery Care (MGMC)
Acronym
MGMC
Official Title
Black Midwives for Black Women: Maternity Care to Improve Trust and Attenuate Structural Racism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
May 15, 2026 (Anticipated)
Study Completion Date
February 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Patient-Centered Outcomes Research Institute, University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications, Maternal Care Patterns, Patient Engagement

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
432 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MGMC Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Melanated Group Midwifery Care
Intervention Description
Racially concordant maternity care Group prenatal care Racially concordant nursing care coordination Postpartum doula support
Primary Outcome Measure Information:
Title
Patient Engagement-Prenatal Adequacy
Description
Appropriate number (yes/no) and timing of prenatal visits (yes/no) documented in electronic medical records
Time Frame
Birth (T3)
Title
Patient Engagement-Prenatal Adherence
Description
Five tests completed during prenatal period (yes/no), documented in electronic medical record
Time Frame
Birth (T3)
Title
Patient Engagement-Postnatal adequacy
Description
Appropriate number (yes/no) and timing of postnatal visits (yes/no) documented in electronic medical record
Time Frame
1 year postpartum (T6)
Secondary Outcome Measure Information:
Title
Patient activation
Description
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.
Time Frame
Change from baseline through 12 months postpartum (T6)
Title
Patient Autonomy
Description
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.
Time Frame
Change from baseline through 12 months postpartum (T6)
Title
Provider Trust
Description
Trust in Physician Scale, 11 items, range 11-55, Likert 1-5; α =0.85-0.90.
Time Frame
Change from baseline through 12 months postpartum (T6)
Title
Patient Satisfaction
Description
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)
Time Frame
Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)
Title
Mental Well Being
Description
Computerized Adaptive Testing - Mental Health: assessing depression, anxiety, suicidality, substance use disorder, and social determinants of health.
Time Frame
Change from baseline through 12 months postpartum (T6)
Title
Respectful Care
Description
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
Time Frame
Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)
Other Pre-specified Outcome Measures:
Title
Medical Referrals
Description
Referrals to higher acuity medical or obstetric care
Time Frame
12 months postpartum (T6)
Title
Social Referrals
Description
Referrals to higher acuity mental health or social services
Time Frame
12 months postpartum (T^)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kylea L Liese, PhD
Phone
3129961867
Email
kylea3@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacie L Geller, PhD
Organizational Affiliation
University of Illinois Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7316
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kylea L Liese, PhD
Phone
312-996-1867
Email
kylea3@uic.edu
First Name & Middle Initial & Last Name & Degree
Stacie Geller, PhD
Email
sgeller@uic.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Melanated Group Midwifery Care (MGMC)

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