Melanated Group Midwifery Care (MGMC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-49
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Melanated Group Midwifery Care
BehavioralRacially concordant maternity care Group prenatal care Racially concordant nursing care coordination Postpartum doula support
Treatment groups
432 Participants
are divided into 2 treatment groupsGroup A: MGMC Intervention GroupExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Patient Engagement-Prenatal Adequacy
Appropriate number (yes/no) and timing of prenatal visits (yes/no) documented in electronic medical records
Time frame
Birth (T3)2
Patient Engagement-Prenatal Adherence
Five tests completed during prenatal period (yes/no), documented in electronic medical record
Time frame
Birth (T3)3
Patient Engagement-Postnatal adequacy
Appropriate number (yes/no) and timing of postnatal visits (yes/no) documented in electronic medical record
Time frame
1 year postpartum (T6)Secondary outcomes
1
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.
Time frame
Change from baseline through 12 months postpartum (T6)2
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.
Time frame
Change from baseline through 12 months postpartum (T6)3
Provider Trust
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)4
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)
Time frame
Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)Other outcomes
1
Medical Referrals
Referrals to higher acuity medical or obstetric care
Time frame
12 months postpartum (T6)2
Social Referrals
Referrals to higher acuity mental health or social services
Time frame
12 months postpartum (T^)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
University of Chicago
Collaborator
Source ClinicalTrials.gov