Maternal Care Patterns, Patient Engagement, Pregnancy Complications
Conditions
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.
Interventions
BEHAVIORALMelanated Group Midwifery Care
Racially concordant maternity care Group prenatal care Racially concordant nursing care coordination Postpartum doula support
Sponsors
Patient-Centered Outcomes Research Institute
University of Chicago
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes 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.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Adherence | Birth (T3) | Five tests completed during prenatal period (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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medical Referrals | 12 months postpartum (T6) | Referrals to higher acuity medical or obstetric care |
| Social Referrals | 12 months postpartum (T^) | Referrals to higher acuity mental health or social services |
Countries
United States
Contacts
Primary ContactKylea L Liese, PhD
Outcome results
None listed