INTEGRATING RCT AND RWD FOR LONG-TERM NEONATAL OUTCOME EVALUATION: LESSONS FROM THE PRIME STUDY
Author(s)
Rachel Parry, PharmD, PhD1, Ashley Magnavita, MPH1, Eric Stanek, PharmD1, Chia-Chen Teng, MS1, Gayatri Ranganathan, MS, PhD1, Angela C. Fox, MS2, Jay Boniface, PhD2, Paul E. Kearney, PhD3, Hiangkiat Tan, MS, BSPharm1;
1Carelon Research, Wilmington, DE, USA, 2Sera Prognostics, Salt Lake City, UT, USA, 3Sera Prognostics, Seattle, WA, USA
1Carelon Research, Wilmington, DE, USA, 2Sera Prognostics, Salt Lake City, UT, USA, 3Sera Prognostics, Seattle, WA, USA
OBJECTIVES: The Prematurity Risk assessment combined with clinical intervention for Improving neonatal outcoMEs (PRIME) study is a prospective, randomized controlled trial (RCT) evaluating the safety and efficacy of a preterm birth prevention strategy. Exploratory objectives include assessment of healthcare resource utilization (HCRU) and costs for participants and their babies for up to 3 years after delivery, requiring linkage of RCT data with real world data (RWD) in the Healthcare Integrated Research Database (HIRD®), a large national health insurance claims database.
METHODS: HCRU and cost data were retrieved from the HIRD, which includes healthcare claims from Elevance Health (ELV) commercial and Medicaid insurance plans. At study enrollment, additional informed consent was obtained from participants covered under an ELV plan to access, link, and use their and their baby’s claims data for analysis. Participant identifiers were used to locate them in the HIRD and link babies to mothers using a published algorithm.
RESULTS: Of 5,018 enrolled participants, 1,243 were verified as ELV plan enrollees; 1,054 (85%) were identified with deliveries in the HIRD; and 994 mothers (94%) met final criteria for pre-/post-delivery outcomes. Of the 1,054 mothers in the HIRD, we successfully linked 627 (59%) babies for inpatient outcomes at birth. Carelon Research has assembled the integrated RCT and HIRD databases and completed the initial phases of this analysis and will be completing the planned analyses in babies through 3 years of age.
CONCLUSIONS: Linking HIRD insurance claims data to RCT data supported inclusion of outcomes which are otherwise challenging and cost-prohibitive to collect prospectively. HCRU and cost outcomes provide a more comprehensive view of outcomes in combination with primary RCT endpoints. When planning to include RWD with an RCT, it’s important to proactively discuss and plan for risks associated with the consenting process, insurance verification and data integration between data sources.
METHODS: HCRU and cost data were retrieved from the HIRD, which includes healthcare claims from Elevance Health (ELV) commercial and Medicaid insurance plans. At study enrollment, additional informed consent was obtained from participants covered under an ELV plan to access, link, and use their and their baby’s claims data for analysis. Participant identifiers were used to locate them in the HIRD and link babies to mothers using a published algorithm.
RESULTS: Of 5,018 enrolled participants, 1,243 were verified as ELV plan enrollees; 1,054 (85%) were identified with deliveries in the HIRD; and 994 mothers (94%) met final criteria for pre-/post-delivery outcomes. Of the 1,054 mothers in the HIRD, we successfully linked 627 (59%) babies for inpatient outcomes at birth. Carelon Research has assembled the integrated RCT and HIRD databases and completed the initial phases of this analysis and will be completing the planned analyses in babies through 3 years of age.
CONCLUSIONS: Linking HIRD insurance claims data to RCT data supported inclusion of outcomes which are otherwise challenging and cost-prohibitive to collect prospectively. HCRU and cost outcomes provide a more comprehensive view of outcomes in combination with primary RCT endpoints. When planning to include RWD with an RCT, it’s important to proactively discuss and plan for risks associated with the consenting process, insurance verification and data integration between data sources.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
SA45
Topic
Study Approaches
Disease
SDC: Pediatrics, SDC: Reproductive & Sexual Health