Case Study Clinical Trials & Research October 31, 2022 Understanding disparities in maternal health through the Scripps Research Digital Trials Center’s PowerMom study The Scripps Research Digital Trials Center launched the PowerMom study to help understand reproductive health and what leads to healthy pregnancies and healthy babies for every pregnant person. Starting in late 2021, the study started using the MyDataHelps™ digital clinical research and public health platform for recruiting, screening, eConsenting, and engaging participants while also collecting electronic clinical outcome assessments (eCOA), electronic health record (EHR), and wearable data. Background There are approximately six million pregnancies and four million births in the United States every year. However, there are also 700 deaths within this population each year. Despite the startling high maternal mortality rates, pregnant people are often underrepresented in research, creating a missed opportunity to increase our understanding of pregnancy-related deaths. In fact, the United States has the highest rate of maternal mortality among developed or industrialized countries, making maternal mortality a public health emergency. Maternal Mortality Rates in Selected Countries, 2018 or Latest Year Source: Roosa Tikkanen et al., Maternal Mortality and Maternity Care in the United States Compared to 10 Other Developed Countries (Commonwealth Fund, Nov. 2020). https://doi.org/10.26099/411v-9255 Compounding the maternal mortality issue is the prevalence of racial disparities in maternal health. According to the CDC, the overall maternal mortality rate in the United States is 17.4 deaths/100,000 live births. For non-Hispanic Black women, however, this rate jumps to 37.1 deaths/100,000 live births—Black women are three times more likely to die from a pregnancy-related complication than white women. To help address maternal health disparities, the Scripps Research Digital Trials Center has partnered with a number of leading institutions and organizations across the country—including Microsoft, WebMD, March of Dimes, and more—to launch the PowerMom study. As one of these partners, CareEvolution has provided the MyDataHelps™ digital clinical research and public health platform to help the study reach participants across the country and collect data that will be used to answer important questions about what makes for a healthy pregnancy and a healthy baby for every pregnant person. By the numbers 46 States 4.4K+ Surveys delivered Cohort PowerMom enrolls people who are: Pregnant or less than 8 weeks postpartum Over 16 years old Residents of the US or US territories English or Spanish speaking Data collection A wide variety of real-world participant data is shared by PowerMom participants: eCOA, including electronic patient-reported outcomes (ePROs) and performance outcomes (PerfOs) Wearable device data EHR data (optional) After enrolling as a participant in PowerMom, individuals are asked to connect to a wearable device—either their own or they may be eligible for a study-provided device—to share information like physical activity, sleep, and heart rate with the study. In addition, participants provide ePROs throughout the duration of their pregnancy and up to eight weeks postpartum. They also have the option to share their EHR data with the PowerMom study. Data collected through PowerMom is securely stored through the MyDataHelps™ platform. Scripps Research also maintains a Certificate of Confidentiality that protects participants’ privacy throughout their participation in the study and beyond. MyDataHelps™: bringing PowerMom to life CareEvolution’s MyDataHelps™ decentralized clinical study platform allows any individual meeting the eligibility criteria to access the technology and contribute to maternal health research through the PowerMom study. Remote participation As a free digital clinical research and mobile health application, MyDataHelps™ facilitates participation in PowerMom by any pregnant person by removing geographic barriers and enabling fully remote enrollment and data collection. By bringing the research to the participant, this helps create more equal opportunity for who can participate in research. Pregnant individuals can be recruited for PowerMom without requiring a clinic visit, through social media (e.g., LinkedIn, Twitter, Facebook) or ads on other pregnancy apps (e.g., WebMD Pregnancy App, Pregnancy + | Tracker App). In addition, potential participants can navigate directly to the MyDataHelps™ web or mobile app to be screened and electronically consented. Along with recruitment, screening, and enrollment, participants are able to provide data throughout the PowerMom study right from their smartphones. As a decentralized mHealth platform, MyDataHelps™ allows for remote data collection through ePROs, PerfOs, EHR connections, and wearable devices—with participants’ own devices or select participants may be eligible to receive a free Fitbit. In addition, MyDataHelps™ encourages participation through automated notifications that help remind participants when they have surveys available to complete. Participant engagement and education PowerMom is not only a research study, but also an educational tool for pregnant people. While PowerMom serves as a safe and private way to include this vulnerable population, it also aims to achieve equity in maternity health. To this end, through MyDataHelps™ dashboards, PowerMom provides resources to participants for them to learn about maternal health. Next steps PowerMom will continue to enroll participants as they aim to understand what makes for healthy pregnancies and healthy babies for every pregnant person. In addition, the team plans to launch sub-studies to learn more about various components of maternal health, including an initial postpartum sub-study in partnership with Woebot Health, a PowerMom consortium member, to begin addressing mental health challenges around pregnancy. Ultimately, the information collected through PowerMom can serve as a valuable tool for addressing a major public health concern.
