Health Condition Being Studied
The United States faces a maternal health crisis. In 2021, more than 800 women died from pregnancy-related complications with women of color and those living in areas of lower socioeconomic conditions at highest risk.
Rationale for and Importance of the Study
The leading causes of maternal deaths are related to bleeding, high blood pressure, heart disease, infection and mental health issues. The majority of pregnancy-related deaths occur after birth. How best to combat this crisis and overcome barriers to care during the six weeks after childbirth is not clear.
Study Objectives and Specific Aims
The long-term goal of the Improving Maternal Postpartum Access to Care through Telemedicine (IMPACT) study is to reduce maternal morbidity and mortality. The immediate goal is to compare two evidence-based postpartum interventions in Black and Hispanic populations of lower socioeconomic status. The primary research question is, “Does an enhanced virtual care model improve early detection and care of postpartum complications?” To ensure a patient-centered design, the IMPACT study is based on input and endorsement from patients, providers, community members and stakeholders.
The study has five aims:
- Aim 1 addresses a health care outcome to identify which care model improves early detection of, and timely care for, postpartum complications.
- Aim 2 evaluates which model successfully reduces hospital readmissions.
- Aim 3 defines ways to improve patient knowledge of postpartum complications.
- Aim 4 defines patient feedback, social determinants of health and provider satisfaction.
- Aim 5 evaluates the impact of care on health outcomes at one year.
The IMPACT study will provide information to optimize timely care and health outcomes.
This large, randomized trial in two cities will compare care models for women who have recently delivered a baby. The study will be conducted in two phases. An initial phase will collect baseline information and ensure patient input, followed by a second phase that will compare two care models.
Who Can Use Results from This Study and How
The data will help us understand how to identify and treat problems after birth. This study will also help patients and providers identify best practices for educating and caring for postpartum patients. This information can help patients, their families, health care providers, communities and insurance providers determine the best ways to provide health care after birth.
The Patient Population and How They Will be Recruited for the Study
The study population will be women delivering babies in two inner-city health systems: Parkland (Dallas, Texas) and Grady Memorial Hospital (Atlanta, Georgia). Almost 14,000 deliveries occur yearly at these two hospitals, and most have public insurance (Medicaid) or no insurance. In phase 1, women will be enrolled to get input and understand their needs. With feedback from phase 1, women will be enrolled in phase 2 and assigned to one of two models.
The study will have two groups: (1) an intensive education model with ongoing virtual education and communication via push notifications, and (2) a telehealth model. The push notifications are the opposite of the “pull” approach of telehealth visits. Women in both groups may participate in existing home visit programs separate from the study.
Primary and Secondary Outcomes
The primary outcome is time from hospital discharge to diagnosis and treatment of complications in the first six weeks after birth. These include blood pressure, wound infections and heart problems. This study will find out which method will decrease the time to diagnose or treat complications by 40 percent. Secondary outcomes will include mental health disorders like depression and anxiety, number of emergency room visits, hospital admissions, patient knowledge, patient quality of life and satisfaction, and provider satisfaction. Data will be gathered using surveys and medical tests such as blood pressure readings and blood sugar values.
Women who delivered a baby, their family members, community members, providers and insurance companies were all asked to help design this study. They were asked about the types of study questions, outcomes and interventions that would provide information on how to best care for women after birth. The study team also engaged city council leaders to understand how reliable internet access would be best available. Findings can potentially help improve care in other health care settings.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.