Abstract
BACKGROUND: Congenital heart disease (CHD) is a birth defect of the heart that requires long-term care and often leads to additional health complications. Effective educational strategies are essential for improving health literacy and care outcomes. Despite affecting around 40,000 children annually in the United States, there is a gap in understanding children's health literacy, parental educational burdens, and the efficiency of health care providers in delivering education. OBJECTIVE: This qualitative pilot study aims to develop tailored assessment tools to evaluate educational needs and burdens among children with CHD, their parents, and health care providers. These assessments will inform the design of medical education toys to enhance health management and outcomes for pediatric patients with CHD and key stakeholders. METHODS: Through stakeholder feedback from pediatric patients with CHD, parents, and health care providers, we developed three tailored assessments in two phases: (1) iterative development of the assessment tools and (2) pilot testing. In the first phase, we defined key concepts, conducted a literature review, and created initial drafts of the assessments. During the pilot-testing phase, 12 participants were recruited at the M Health Fairview Pediatric Specialty Clinic for Cardiology-Explorer in Minneapolis, Minnesota, United States. We gathered feedback using qualitative methods, including cognitive interviews such as think-aloud techniques, verbal probing, and observations of nonverbal cues. The data were analyzed to identify the strengths and weaknesses of each assessment item and areas for improvement. RESULTS: The 12 participants included children with CHD (n=5), parents (n=4), and health care providers (n=3). The results showed the feasibility and effectiveness of the tailored assessments. Participants showed high levels of engagement and found the assessment items relevant to their education needs. Iterative revisions based on participant feedback improved the assessments' clarity, relevance, and engagement for all stakeholders, including children with CHD. CONCLUSIONS: This pilot study emphasizes the importance of iterative assessment development, focusing on multistakeholder engagement. The insights gained from the development process will guide the creation of tailored assessments and inform the development of child-led educational interventions for pediatric populations with CHD.