Implementation evaluation of an evidence-informed hospital inpatient nursing framework (HIRAID® Inpatient): a protocol for a stepped-wedge cluster RCT

Abstract Background Preventable adverse events in Australian hospitals are a significant safety issue, causing harm, death and increased healthcare costs. Many stem from inadequate recognition of, or response to, clinical deterioration by nurses that suggest gaps in current nursing practice frameworks. Responding to health sector demand, this study will adapt the evidence-informed HIRAID® nursing framework for use in hospital inpatient settings, implement and evaluate the standardised HIRAID® Inpatient framework to improve the quality and safety of inpatient hospital care. Methods HIRAID® will be adapted for the hospital inpatient setting using a real-time Delphi technique and co-design with frontline hospital inpatient nurses, consumers, managers, physicians and allied health clinicians (Phase 1). An explanatory mixed methods study incorporating staff surveys and focus groups, informed by behaviour change theory, will be used to generate the implementation strategy (Phase 2). The intervention will be trialled with 1259 nurses from 35 inpatient wards (10 hospitals) across three health services in two Australian states, using a Type II hybrid effectiveness-implementation design, including a Stepped-Wedge clustered Randomised Control Trial (Phase 3). There will be four clusters, determined by geography and clinical governance, where 4050 patients are admitted per month. These clusters were selected due to their direct admission of acutely unwell patients that are at a high risk of experiencing adverse events. Routinely collected data, guidance documents, and pre- and post-intervention surveys of patients, carers, nursing and medical staff will be used to test the seven study hypotheses. Sample size calculations were based on prior research, assuming a 3% intra-class correlation, 5% significance (two-tailed) and 80% power, and using Woertman’s Stepped-Wedge estimate approach. Evaluation of implementation and fidelity will be assessed using the RE-AIM framework. Outcomes of interest include rates of preventable nurse-associated clinical deterioration, hospital-acquired complications, patient and carer experiences with care, and quality of nursing documentation and communication. Discussion HIRAID® Inpatient aims to optimise nurses’ contribution to the quality and safety of hospital nursing care by preventing adverse events, improving patient experiences and strengthening clinical communication through a standardised, evidence-informed framework for assessment, decision-making and action. Trial registration Australian and New Zealand Clinical Trial Registry, ACTRN12625000639426. Registered on 17 June 2025, https://anzctr.org.au/ACTRN12625000639426.aspx . Protocol version Version 5.0 30 April 2025.