Depression, Anxiety, Depression, Postpartum, Health Problems in Pregnancy, Pregnancy Preterm, Premature Birth, Prenatal Stress, Satisfaction, Patient
Conditions
Keywords
Premature Birth, Group Prenatal Care, Respectful Care, Patient Satisfaction, Prenatal Depression and Anxiety, Low Income, Health Inequity, Prenatal Care, Person-Centered Care
Brief summary
This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 674 Medi-Cal eligible pregnant individuals in Fresno, California. The goal is to see whether group prenatal care with wrap around services versus individual prenatal care supplemented by services covered by the California Department of Public Health Comprehensive Perinatal Services Program (CPSP) results in less depression and anxiety, and more respectful, more person-centered maternity care and lower rates of preterm birth.
Interventions
OTHERGlow! Group Prenatal Care
Glow! is an enhanced group prenatal care model that offers co-located social services provided by established community programs with independent funding streams targeting low-income families. The Glow! group prenatal care model pairs a trained facilitator with a licensed prenatal care practitioner from a practice site to provide billable prenatal care to the practice's own patients. Over the course of 8-10 sessions, 10-12 women (within a 6- week gestational age range) receive prenatal medical care, risk assessments, and social support, and gain knowledge and skills related to pregnancy, birth, and parenting.
OTHERIndividual Prenatal Care with CPSP
Comprehensive Perinatal Services Program (CPSP) is a state-funded program for Medi-Cal eligible families to receive enhanced care and service coordination. Participants assigned to CPSP individual care may participate in the CPSP assessments with a Comprehensive Perinatal Health Worker at their prenatal care site, where individual prenatal care will be provided
Sponsors
University of California, San Francisco
Patient-Centered Outcomes Research Institute
California State University, Fresno Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Between 8 and 24 weeks gestation at enrollment * Eligible for Medi-Cal (at or below 213% of the federal poverty level) * Speak English or Spanish
Exclusion criteria
* Unavailable to attend group prenatal care sessions * Not planning to continue prenatal care with site provider * Cannot legally consent to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Patient Health Questionnaire (PHQ-9) Score | Collected from study enrollment to three months postpartum | Changes in depressive symptom severity from baseline to postpartum. Assessed using the Patient Health Questionnaire (PHQ-9), administered in-person at baseline and during telephone interview at three months postpartum. Total score ranges from 0-27 with higher scores indicating more severe depression. |
| Person-centered Prenatal Care | Collected during third trimester | This outcome focuses on the extent to which the participants feels their prenatal care was person centered. The title of the measure is Person Centered Prenatal Care (primary). This measurement tool is a questionnaire that includes series of items that were developed in collaboration with community members to measure their experience of care. In addition to the overall score, the scale includes three subscales identified as important by community members: dignity and respect, communication and autonomy, and responsive and supportive care. The measures have been validated in several languages. The total scores range from 0-100 with higher scores indicating the receipt of more person centered care. |
| Preterm Birth | 0-12 weeks after delivery | Whether the participant had a baby born less than 37 weeks gestation, as noted in the participant's medical record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Anxiety Symptom Severity | Collected from study enrollment to three months postpartum | Changes in anxiety symptom severity from baseline to postpartum. Assessed using the 7-item Generalized Anxiety Disorder (GAD-7) scale, administered in-person at baseline and during telephone interview at three months postpartum. The total scores range from 0-21 with higher scores indicating more severe anxiety. |
| Perceptions of Respectful/Disrespectful Maternity Care | Collected at three months postpartum | Extent to which the participant feels that the maternity care they received was respectful. Assessed using the Mothers on Respect Index (MORi), administered during telephone interview or in-person at three months postpartum. The total scores range from 14-100 with higher scores indicating a higher level of respect. |
| Satisfaction With Prenatal Care | Collected during third trimester | Extent to which the participant feels satisfied with the prenatal care they received. Assessed using the Prenatal Care Satisfaction Scale, administered during telephone interview or in-person interview at third trimester. The total scores range from 0-100 with higher scores indicating higher levels of satisfaction. |
| Gestational Age at Delivery | 0-12 weeks after delivery | The gestation age at which the baby was born (number of weeks), as noted in the participant's medical record. |
| Person Centered Maternity Care | 3 months postpartum | Extent to which birthing person feels their prenatal and birthing experience was person centered, as measured by the Person-Centered Maternity Care scale. This measure focuses on the extent to which the participants feels their prenatal and maternity/birthing care was person centered. The title of the measure is Person Centered Maternity Care. This measurement tool is a questionnaire that includes series of items that were developed in collaboration with community members to measure their experience of care. In addition to the overall score, the scale includes three subscales identified as important by community members: dignity and respect, communication and autonomy, and responsive and supportive care. The measures have been validated in several languages. The total scores range from 0-100 with higher scores indicating the receipt of more person centered care. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMiriam Kuppermann, PhD, MPH
University of California, San Francisco
Participant flow
Pre-assignment details
678 were enrolled in the study, but 4 dropped out and requested that none of their data be used in analysis.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 26.5 Years STANDARD_DEVIATION 5.6 |
| Race/Ethnicity, Customized African American or Black | 28 Participants |
| Race/Ethnicity, Customized Bi-or multi-racial/ethnic | 36 Participants |
| Race/Ethnicity, Customized Latine | 275 Participants |
| Race/Ethnicity, Customized Other | 13 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants |
| Race/Ethnicity, Customized White | 73 Participants |
| Sex: Female, Male Female | 652 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 294 | 0 / 380 |
| other Total, other adverse events | 0 / 294 | 0 / 380 |
| serious Total, serious adverse events | 0 / 294 | 0 / 380 |
Outcome results
None listed