Developing and Piloting a Parent-Facing Tool to Improve Neonatal Clinical Trial Recruitment

/ABSTRACT The neonatal intensive care unit (NICU) setting is a challenging environment for research enrollment decision- making. NICU parents are often asked to consider research enrollment at a time of high stress, to make a decision within a narrow enrollment window, and, in many cases, to do so with no previous experience either being in the NICU or participating in clinical research. Our prior work, which has examined NICU parents’ perspectives about research and developed relationship-oriented communication approaches to guide researchers during recruitment and informed consent discussions, suggests that NICU parents would be better able to engage in research discussions if they had advance preparation. This project aims to address this gap by developing and piloting a parent-facing tool to improve NICU parents’ readiness to engage with clinical researchers. Based on our prior work, we expect that such a tool can promote higher quality informed consent discussions and improve parents’ experiences, which on a population level we expect to increase overall enrollment in NICU clinical research. In this project, we will first develop a parent-facing tool, guided by the framework of Intervention Mapping, a rigorous method that will allow for tool development that is informed by relevant stakeholder values and behavioral theory. The web-based tool, accessible via a mobile device, will use multimedia and interactive features to share key topics about NICU clinical research. Second, we will pilot test the feasibility and acceptability of administering the parent-facing tool to NICU parents in 3 US NICUs (Seattle, WA; Houston, TX; Boston, MA). Primary outcomes of feasibility of integrating the tool into NICU clinical practice and acceptability of the tool to key stakeholders will be evaluated through surveys of NICU physicians and nurses, interviews of NICU research staff, surveys of NICU parents after reviewing the tool, and embedded usability metrics within the tool. Secondary outcomes to estimate impact on parents’ preparedness for decision-making and enrollment rates will be measured through additional parent survey measures and clinical trial enrollment logs. Informed by the results of this pilot study, we will refine the parent-facing tool and incorporate it alongside our previously developed researcher-facing intervention to evaluate their joint impact on parental decision-making. Project Number: 1R21HD121923-01 | Fiscal Year: 2026 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Elliott Weiss (+1 co-PI) | Institution: SEATTLE CHILDREN'S HOSPITAL, SEATTLE, WA | Award Amount: $252,887 | Activity Code: R21 | Study Section: Special Emphasis Panel[ZRG1 SEIR-L (80)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11351407