Patient safety is crucial in healthcare, especially in home-based settings where unregulated environments and limited supervision pose unique challenges. With the expansion of home healthcare due to an ageing population and healthcare workforce shortages, there is a pressing need for tools to assess patient safety culture in this context. Current instruments, developed for hospitals, do not adequately address the specific dynamics of home healthcare, such as patient autonomy and caregiver involvement. This protocol outlines the development and validation of the Patient Safety Culture in Home Health Care Centers Instrument (PSCHCI), using a sequential exploratory mixed-methods approach.

This sequential exploratory mixed-methods protocol consists of three phases. Phase 1 fieldwork (semi-structured interviews with 15 participants, 3 participant observations and field notes) has been completed. Qualitative data are currently being analysed using conventional content analysis. The scoping review component of Phase 1 is planned but has not yet been conducted. Phase 2 (instrument development) is planned to include item generation from qualitative results followed by expert panel review. Phase 3 (psychometric evaluation), scheduled for late 2026, will employ a cross-sectional study to assess face, content and construct validity; reliability; interpretability; and feasibility. This phase features pilot testing (n=30–50), face and content validity assessment (n=10 each), test-retest reliability (n=15) and exploratory and confirmatory factor analyses (n=300–400).

Ethical approval was obtained from the Ethics Committee of Iran University of Medical Sciences. All participants will provide written informed consent. Confidentiality, voluntary participation and withdrawal rights are guaranteed. Findings will be published in peer-reviewed journals, presented at conferences and shared with participating home healthcare centres, policymakers and stakeholders.