About this trial
The purpose of this study is to compare two complex, multi-component evidence-based postpartum interventions in underserved populations of lower socioeconomic status in an effort to reduce maternal morbidity and mortality.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Postpartum women who deliver a live born infant at Parkland Hospital or Grady Health and receive postpartum care at dedicated community clinics.
Due to the nature of the study, all will be women, and all will be postpartum, thus of reproductive age. Postpartum women 18 years of age and older will be considered for inclusion if informed consent can be obtained.
Disqualifiers
Postpartum women who do not deliver at Parkland Hospital or Grady Health will not receive postpartum care in the pre-specified community clinics for Parkland health systems.
Patients with a primary language other than English or Spanish.
Trial design
Parallel
Treatments tested in this trial
Intensive Education
Other interventionIntervention will consist of virtual education and communication through scheduled push notifications
Enhanced Virtual Care
Other interventionIntervention will utilize a telehealth model consisting of "pull" approach of patient engagement.
Treatment groups
Trial outcomes
Primary outcomes
Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge
Time to diagnosis and treatment of postpartum complications including hypertension, wound infection, and venous thromboembolism, measured in days. Lower value is considered better, representing timely care.
Secondary outcomes
Edinburgh Postnatal Depression Scale
screening continuous, numerical; higher value consistent with great risk of postpartum depression
Generalized Anxiety Disorder 7
screening tool, continuous, numerical, higher value consistent with higher risk of anxiety disorder
Number of patients requiring emergency room visits, % preventable
continuous variable, preventability to be determined by preventability panel
Number of patients requiring hospital admissions, % preventable
continuous variable, preventability to be determined by preventability panel
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Emory University
Collaborator