Development and psychometric properties evaluation of individualized patient education tool: An exploratory sequential mixed-methods study protocol

Patient education is an important component of nursing care, influencing treatment outcomes, quality of life, and healthcare costs. However, educational practices are often generalized and may not address patients' individual needs, health literacy, or socio-cultural contexts. Individualized patient education tailors content to patients' characteristics, goals, and capabilities, and enhances adherence, satisfaction, and clinical outcomes. Existing tools mainly focus on general aspects of patient education, such as educational quality or provider competencies, and no comprehensive patient-centered tool has been established to assess the individualized nature of patient education. This may constrain systematic assessment and improvement of individualized educational practices. Therefore, this protocol aims to conceptualize individualized patient education, develop a measurement tool, and evaluate its psychometric properties.

This two-phase exploratory sequential mixed-methods study will be conducted in educational hospitals affiliated with Tabriz University of Medical Sciences, northwest Iran. Phase 1 will involve hybrid concept analysis, including a literature review and directed qualitative study using semi-structured interviews with patients with chronic diseases and their family members until data saturation, followed by directed content analysis to clarify the concept, identify provisional dimensions, and generate initial items, which will be evaluated quantitatively. Phase 2 will assess the tool's psychometric properties. Face and content validity will be evaluated using qualitative feedback and the Impact Score, Content Validity Ratio, Content Validity Index, and Modified Kappa coefficient. Construct validity will be examined using exploratory and confirmatory factor analyses in SPSS v.24 and AMOS v.24, with independent samples of at least 200 participants per analysis. Reliability will be assessed using Cronbach's alpha, McDonald's omega, and test-retest stability. Interpretability and feasibility will also be evaluated.

If the tool demonstrates adequate validity and reliability, it may provide a standardized measure for assessing individualized educational interventions and support quality improvement, patient engagement, and evidence-informed health education strategies.