Evaluating the implementation of a hospital inpatient nursing framework: HIRAID® (History including Infection risk, Red flags, Assessment, Interventions, Diagnostics, reassessment, and communication) Inpatient

Clinical Trial: This study will use an effectiveness-implementation hybrid design, including a Stepped–Wedge cluster Randomised Control Trial (SW-cRCT). The hybrid approach allows testing of the implementation strategy at the same time as observing the outcomes of the intervention. A SW-cRCT design is appropriate for health service interventions as it simplifies data collection procedures, better supports logistical processes, accommodates temporal issues and optimises resource use. Approximately 18m of data collection for intervention and control. The SW-cRCT will follow four steps. Facilities will be assigned to one of four clusters, with all clusters beginning in the control phase (Step 1), where baseline data and behavioural diagnostics will be collected. This step will take between 3-12 months, dependant on the cluster. A context-specific implementation strategy will be developed based on the information collected at baseline and behavioural diagnostics. Next (step 2), the HIRAID® Inpatient intervention will be implemented with nursing staff over three months. Step 3 will include official post-intervention data collection, lasting between 3-12 months, depending on the cluster. Each facility’s trial, from baseline data collection (step 1) to the end of outcome measurement (end of step 3)– is estimated to take 18 months. The SW-cRCT for all four clusters is estimated to also take about 18m depending on individual clusters. Finally in Step 4, data from all sources will be integrated, and the process of review, knowledge translation and dissemination will commence. Partners will be consulted to evaluate and produce the final HIRAID® Inpatient toolkit. Initial stages of effectiveness-implementation evaluation and refinement for upscale will commence. Study Plan Type II effectiveness-implementation hybrid study to measure the effect (effectiveness) and uptake (implementation) of HIRAID® on patient, staff and health service outcomes including a stepped-wedge clustered randomised Control Trial (SW-cRCT) ~18m (of data collection for intervention and control).: Developing/adaptation of implementation strategies Cluster-specific modifiable implementation strategies will be developed (pre step 1) using the Theoretical Domains Framework (TDF) and Behaviour Change Wheel (BCW) for approximately 9m prior to the start of the SW-cRCT, with implementation components being ready to deploy 3m later, alingning with the end of cluster 1's baseline data. Behavioural diagnostics, through nurse surveys and focused groups, will identify enablers and barriers to implementing HIRAID® Inpatient. The nursing workforce positions are Registered Nurses, Nurse Unit Managers, Clinical Nurse Consultants, Nurse Practitioners and Clinical Nurse Educators. All hospital inpatient nurses employed permanently (full and part-time) and casual staff on the study wards will be invited to complete the survey. Semi-structured focus group interviews with consenting ward leaders and nurses will be conducted on-site and audio recorded. Qualitative data will be collected through these focus groups to gain a deeper understanding of the barriers and enablers to HIRAID® Inpatient implementation identified in the survey by exploring aggregated survey responses. Findings will be mapped to the TDF and BCW, to inform the development, adaptation, and preparation of site-specific strategies. The BCW will be used to connect enablers and barriers to specific intervention functions and techniques for sustained behaviour change. Survey: The survey will involve distributing four emails to eligible participants: one initial invitation when the survey opens, and one reminder email weekly until after the initial invitation and until the survey closes. Participants will have four weeks from the first invitation to consider participation and to complete the survey. After completing the electronic survey pre-intervention, nurses will also be invited to participate in a focus group with a member of the research team. This will collect more comprehensive, qualitative data on nurses’ perception of the intervention and enabler / barriers to HIRAID® Inpatient and its implementation. Focus groups: Semi structured focus group interviews with consenting ward leaders and nurses will be conducted on site that will be audio recorded. Qualitative data will be collected via focus groups to provide a greater understanding of the barriers and enablers to HIRAID® Inpatient implementation identified in the survey by exploring aggregated survey responses. Focus groups are commonly used in health research to gain more understanding of phenomena. Four to six focus groups (or until data saturation) will be conducted for each cluster. It is anticipated four to eight participants will be involved in each focus group. The focus groups will be conducted in a private room away from the clinical area to minimise distraction but enable clinicians in an emergency to quickly return to the clinical area. The focus groups will be conducted over a three-month period. The final implementation strategy will be refined using behaviour change techniques taxonomy and the APEASE criteria as baseline data is collected (Steps 1-2). This method that was successfully applied to the implementation of HIRAID® in the ED. Once survey results are integrated, the new findings will be mapped to the TDF to enable a comprehensive, targeted theory-informed approach to the development of the implementation strategy. The TDF is used to identify determinants of behaviour and provide comprehensive and systematic approaches to intervention implementation. The mapped TDF domains will be integrated into the BCW, through linking to intervention function(s). The BCW is a validated series of tools for developing behaviour change interventions and shown to improve the sustained success of clinical interventions. Intervention functions form part of the BCW and are designed to influence behaviour by addressing capability, opportunity, and motivation. If items cross multiple TDF domains and, or intervention functions, the research team will resolve this through a discussion, led by a senior member of the research team with extensive experience in the use of the TDF and behaviour change theories. Education and training of nursing staff All nursing staff will receive pedagogically informed (1) education regarding the theory and practice of HIRAID® Inpatient. The education approach will be co-designed with experts from the participating organisations and will be grounded in principles of constructive alignment (2-4) backwards design(5) and scaffolded learning (6). HIRAID® Inpatient training will initially be provided to senior/ management/ Clinical Nurse Consultant (CNC)/ Clinical Nurse Educator (CNE) staff at each site, followed by separate sessions for the remaining Registered Nurse (RN) and Enrolled Nurse (EN) workforce. Senior RNs will also complete HIRAID® Inpatient Instructor training, to independently deliver HIRAID® Inpatient training, ensuring sustainability. Completion of HIRAID® Inpatient training will be mandatory for all new nursing staff, this will be integrated into orientation and onboarding programs through the established instructor base. Integration of HIRAID® framework into hospital systems HIRAID® Inpatient documentation templates will be incorporated into local electronic and paper-based documentation systems. A standardised template will be created for HIRAID® Inpatient, will include fields and prompts for all framework elements. Integration will be adapted based on local factors, such as use of electronic or paper-based documentation, and in the case of electronic documentation, the product(s) used (e.g. PowerChart), automation features, and compatibility with existing tools. The documentation templates will be designed to streamline assessment documentation, minimise duplication, administrative burdens, and redundancies for hospital ward nurses. Supporting materials Several strategies willl be tailored to address hospital-specific barriers will be deployed to support implementation. Co-designed educational materials will provide easy access to learning and support. Environmental cues such as posters and reference cards will offer immediate reminders of HIRAID® Inpatient structure and elements. Implementation Research nurses and nurse champions from the nursing workforce will positively reinforce adoption. Research implementation nurses will conduct fortnightly audits of nursing documentation to monitor uptake, maintain a record of implementation strategies executed within their allocated cluster, provide updates, identify teaching opportunities and address implementation issues. 1. Shaban RZ CK, Fry M, McCormack B, Parker D, Lam MK, Low LF, Jeon YH, Waters D, Lindley RI, Watson K, Dunsmore M, Considine J, Squillacioti G, Thompson L, Smith A, Begum M, Dalton JA, Ramsden C, Glennan J, Viengkham C. . Nurse-led framework to improve the safety and quality of residential aged care (HIRAID® Aged Care): protocol for a stepped-wedge cluster randomised controlled trial. Trials. 2024;25(1):737. 2. Biggs J, Tang C. Constructive alignment: An outcomes-based approach to teaching anatomy. Teaching anatomy: A practical guide: Springer; 2014. p. 31-8. 3. Biggs J, Tang C, editors. Applying constructive alignment to outcomes-based teaching and learning. Training material for “quality teaching for learning in higher education” workshop for master trainers, Ministry of Higher Education, Kuala Lumpur; 2010. 4. Biggs J. Enhancing teaching through constructive alignment. Higher education. 1996;32(3):347-64. 5. Wiggins GP, McTighe J. Understanding by design: Ascd; 2005. 6. Wood D, Bruner JS, Ross G. The role of tutoring in problem solving. Journal of child psychology and psychiatry. 1976;17(2):89-100.