P2.F111: Equity and Understanding in Neonatal Research: A Quality Improvement Approach.

Purpose/Objectives: Randomized clinical trials (RCTs), resulting in generalizable, high-quality evidence, are required to establish the safety and efficacy of treatments for the practice of evidence-based medicine (EBM). Neonatal intensive care units (NICUs) are especially complex environments in which to conduct clinical research, and this complexity may increase the vulnerability of certain populations to the risks of participation. This project aimed to describe the sociodemographic characteristics of families who were approached to participate in one or more research studies, with a focus on the effect of approaching families in their native language.

Design/Methods: A longitudinal, quality improvement (QI) project was implemented in a tertiary care teaching hospital focused on increasing approach rate of eligible patients by 10% over two years, increasing enrollment rates and improving satisfaction of families with research participation in the NICU. As part of that project, sociodemographic data was collected from January 2022 to December 2023. We measured approaches and enrollments in five interventional studies and four observational studies.

Results: We approached 289 birthparents and their families, of whom 189 (65%) consented to participate in one or more studies. In univariate analyses, we found statistically significant higher enrollment rates of infants born at < 32 weeks’ gestational age (p < 0.05), of those from Spanish and Portuguese speaking families (p < 0.05), and of infants of birth parents with private insurance (p < 0.05). We did not find a significant effect with birthparent age, race, marital status, multiple pregnancy, previous preterm and/or term delivery and Social Vulnerability Index. We included the significant factors in a multivariable logistic regression analysis which showed a higher likelihood of enrollment among families approached in Spanish (OR 5.4, p = 0.03) and among those with private insurance (OR 2.6, p< 0.01). Both extremely preterm (OR 2.5, p < 0.01) and moderately preterm newborns (OR 3.6, p = 0.04) had a higher likelihood to participate in research studies (Table 1).

Conclusion/Discussion: This project identifies important contributors to the population of participants in neonatal clinical research. Approaching families in their preferred language was associated with increased enrollment rates. Efforts to increase diversity among research staff may increase diversity in the study population, and therefore generalizability of results. Insurance coverage, or financial status, may influence participation decisions. These exploratory results may be of use in designing quality improvement interventions for the research enrollment and consent process.