About this trial
The investigators primary project goal is to improve clinical outcomes, including mental health outcomes, among postpartum at-risk women experiencing health disparities by increasing awareness, detection, and timely care of postpartum hypertension, mental health and cardiovascular complications. The investigators will accomplish this by comparing the effectiveness of two multi-component multi-level healthcare delivery models focused on early detection and control of postpartum hypertension and the social and mental health factors known to impact maternal outcomes, with the current standard of care and with each other.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Delivery of singleton live birth (twins reduced to singleton or with vanishing twin syndrome prior to 14 weeks qualify)
Postpartum
English or Spanish speaking
Viable pregnancy 24 weeks of gestation or above (Child can be in NICU to participate)
Disqualifiers
Multifetal pregnancy (since are they at increased risk for key outcomes)
Gestational age <24 weeks;
Known major fetal anomaly in current pregnancy or stillbirth
Actively using illicit/illegal substances (such as cocaine, heroin and other types of illicit opiates such as fentanyl) as noted in delivery hospitalization notes
Trial design
Parallel
Treatments tested in this trial
Remote Medical Model (RMM)
Other interventionRemote home blood pressure (BP) monitoring once a day for the first 7 days and then at least weekly or more frequently as per a standardized blood pressure protocol up to six weeks and weekly virtual visits for 6 weeks and up to 12 weeks as needed by a physician extender (e.g. Nurse Practitioner, Pharmacist, etc.), and screening for social determinants of health and anxiety/ depression with referral for services if positive
Community Health Model (CHM)
Other interventionUtilization of community health workers trained in a strength-based trauma informed dyadic evidence-based approach.
SoC
Other interventionSoC for Postpartum Hypertension
Treatment groups
Trial outcomes
Primary outcomes
Change in mean postpartum systolic blood pressure (SBP) at 6 weeks
Change in mean postpartum systolic blood pressure (SBP) at 6 weeks. A reduction in SBP indicates an improvement in postpartum hypertension.
Depression severity at 3 months postpartum assessed using the Edinburgh Postnatal Depression Scale (EPDS).
EPDS is a 10-item validated scale that measures depressive symptoms and is designed for use with pregnant and postpartum women. Scoring: None or minimal depression (0-6), Mild depression (7-13), Moderate depression (14-19), Severe depression (19-30). A reduction in depression severity at 3 months postpartum indicates a positive outcome.
Secondary outcomes
Participant engagement
Engagement with a health care provider by 6 weeks will be assessed via self-report (collected via interview) and electronic medical records (indicator will be whether the participant was engaged in care at least once in the 6 weeks postpartum).
Sponsors and contacts
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Yale University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator