Innovative approaches to data collection: The PRIME Study

Clinical research, particularly related to mother-infant health, plays a significant role in ensuring health breakthroughs and better medical outcomes for generations to come. An excellent example of innovative approaches to data collection involved in clinical research is found in the PRIME study.

In this large pragmatic study designed to focus on pregnancy and neonatal outcomes concerning preterm birth, Carelon Research’s clinical research team employed an innovative and industry-leading approach to data collection. We developed a unique four-tiered mechanism that transformed how data was sourced, managed, and interpreted.

This multimodal data collection strategy primarily sourced data from clinical sites through an electronic data capture (EDC) system. To complement this, our team partnered with a medical record abstraction vendor to access otherwise inaccessible delivery and neonatal records. In addition, after conducting a baseline survey in-person, our team sent follow-up surveys directly to patients participating in the study to efficiently capture secondary outcomes including anxiety. This approach not only alleviated patient burden by preventing another in-person visit, but also minimized the responsibilities of data collection for sites.

A vital part of this integrated approach to data collection was Carelon Research’s ability to link mothers and infants within our Healthcare Integrated Research Database (HIRD®) containing administrative claims and medical records. As a next step, our team will be following PRIME participants and their infants enrolled in commercial health plans to assess health and economic outcomes at 6 months, 1 year, and 3 years after delivery.

This multidimensional integration of data sources spanning direct data entry through EDC, medical record abstraction, direct-to-patient follow-up, and claims data analysis demonstrates our expertise in clinical trial design and execution. It also highlights our special knack for leveraging claims data to generate essential study insights.

Strong operational strategy for clinical research is important for advancing healthcare outcomes. This holds especially true in maternal and neonatal health, where we’re still lacking a comprehensive understanding of pregnancy and birth patterns. Innovative data collection and other methodologies, such as those employed in the PRIME study, play a significant role in advancing our journey towards better clinical decision making and ultimately better health outcomes for mothers and babies.