None listed
Conditions
Brief summary
This study will use a two-stage, mixed-methods design. Stage 1 will involve co-designing a tailored sleep intervention for the Geriatric and Rehabilitation Unit (GARU) using the Double Diamond framework, followed by a 2-week Plan-Do-Study-Act (PDSA) cycle to refine the intervention. Stage 2 will comprise a 4-week feasibility and acceptability trial, with mixed-methods evaluation of protocol adherence, sleep outcomes, and stakeholder feedback.
Interventions
The study will be conducted at the Princess Alexandra Hospital Geriatric and Rehabilitation Unit (GARU) in Brisbane, Queensland. Stage 1: Co-design of Sleep Intervention. Study design: The co-design process will be guided by the Double Diamond framework, a structured, multi-phase approach that incorporates both divergent and convergent thinking. Developed by the UK Design Council in 2005, this framework has been widely applied in co-design research. It consists of four key phases: Discover, which involves exploring problems and gathering insights; Define, where problems are refined; Develop, which focuses on generating and exploring solutions; and Deliver, where solutions are tested and evaluated. The co-design phase will use a modified Delphi methodology combined with structured workshops to generate an intervention protocol. This iterative, consensus-driven approach is ideal for generating stakeholder agreement on complex interventions in clinical settings. Co-design process - Delphi survey and Workshops: Delphi survey rounds • Round 1: Open-ended questions distributed electronically to generate broad ideas around sleep disruption and potential intervention strategies. Questions will be informed by preliminary findings. • Round 2: Stakeholders will rank the feasibility and importance of consolidated strategies identified from Round 1. • Round 3: Stakeholders will re-rank items, informed by group feedback, aiming for consensus (>70% agreement). Following the completion of the Delphi rounds, a series of structured, in-person or virtual co-design workshops will be conducted to further develop and refine the proposed intervention components. These workshops will employ Nominal Group Techniques (NGT) to facilitate equitable participation among all stakeholder groups, including clinicians, Nurse Unit Managers (NUMs), allied health professionals, Queensland University of Technology (QUT) built environment architect scientists, and patient consumers. Through a structured process of idea generation, discussion, and private ranking, NGT will support consensus on the most practical, acceptable, and contextually appropriate strategies to be incorporated into the intervention. The outcomes of these sessions will be synthesised into a preliminary intervention protocol, which will outline operational details such as intervention timing, delivery processes, staff responsibilities, and required resources. This collaborative refinement process ensures the protocol remains aligned with stakeholder priorities while maintaining feasibility within the specific operational constraints of the GARU environment. Data management and analysis plan Statistical analysis: Thematic and descriptive analysis of qualitative survey and structured group discussion responses to identify consensus-driven intervention components. Ethical considerations for participants: Study period: This co-design study will progress from September 2025 to December 2025 and will commence recruitment and participation as soon as appropriate HREC and SSA approvals are obtained. Stage 2: Feasibility and acceptability trial of Intervention Study design: This study is a 4-week feasibility and acceptability trial using a mixed-methods evaluation, incorporating quantitative outcomes and qualitative feedback. Prior to the trial, a 2-week Plan-Do-Study-Act (PDSA) cycle will be conducted to iteratively test and refine interventions, ensuring they are optimised before full implementation. Notably, a longer testing period may be needed to fully refine the protocol to allow for adequate feasibility/ acceptability of the intervention. The PDSA methodology, widely used in healthcare improvement, allows for real-time adjustments based on staff and patient feedback, enhancing both feasibility and acceptability. This iterative approach ensures interventions are practical, patient-centred, and adaptable to the complexities of real-world clinical settings. Outcome Measures: 1. Feasibility: protocol adherence, Recruitment rate (target: greater than or equal to 50% of eligible participants), retention rate. 2. Acceptability: Participant/staff satisfaction surveys (5-point Likert scale). 3. Preliminary Efficacy: Pre-post change in PSQI scores (target: greater than or equal to 3-point reduction). 4. Intervention Barriers/Enablers: Semi-structured interviews with staff and patients. Implementation: The co-designed intervention will be implemented in GARU, targeting environmental (light, noise), behavioural (sleep hygiene and sleep education), and clinical (minimising overnight disruption) elements. The co-designed intervention is likely to be multicomponent and will be considerate of available funding. Environmental strategies may include noise reduction measures such as the use of rubber stoppers on equipment, enforcement of quiet hours, and staff reminders to reduce loud conversations. Earplugs may be offered where safe, alongside light optimisation strategies like dimmable bedside lighting, use of eye masks, and warm light torches for overnight checks. Room allocation may be adapted to relocate patients who are frequently disturbed and to prioritise natural light access for less mobile individuals. White noise machines may also be explored for feasibility. At the behavioural and patient level, interventions may include structured daytime activity schedules to promote circadian alignment - such as morning mobilisation, outdoor time, and evening wind-down routines. Patients may be encouraged to reduce evening screen exposure and engage in relaxing alternatives like audiobooks or music. Sleep hygiene education tailored to cognitive capacity will also be explored. Clinical and workflow strategies may involve reviews of medications that interfere with sleep, and preference for non-pharmacological approaches. Night-time care may be optimised through the clustering of nursing tasks, minimising overnight vital sign checks where clinically appropriate, and timing toileting rounds to reduce disruptions. Additionally, sleep quality and disturbances may be discussed during morning clinical handovers to better inform daily care planning. Staff and system-level strategies will also be critical. Brief training modules may be provided to build awareness of geriatric sleep needs, supported by case studies or simulations. Sleep champions may be designated on each shift to foster a unit culture supportive of sleep, and incentives or recognition systems could reinforce best practice. Integration of sleep into care plans, therapy goals, and discharge summaries will help embed sleep as a core component of patient wellbeing. Finally, sleep experience questionnaires may be completed on discharge, allowing feedback from patients and families to inform ongoing improvements. Most of these interventions will be implemented with aid by nursing staff, with key roles also played by allied health professionals (particularly in daytime activity and sleep education) and medical staff (especially in medication review and clinical oversight). Adherence to the intervention will be monitored using brief ward-level tools such as sleep-focused checklists, updates recorded in clinical handovers, and documentation in the medical record or allied health notes, depending on the nature of the intervention. These strategies aim to ensure both fidelity and flexibility, allowing for iterative refinement as part of the feasibility trial. Study period: This co-design study will progress approximately from December 2025 to March 2026 and will commence recruitment and participation only when appropriate HREC and SSA approvals are obtained.
Sponsors
Study design
Eligibility
Inclusion criteria
Phase 1 inclusion criteria: The study will involve a range of key stakeholders from the Geriatric and Rehabilitation Unit (GARU), including clinicians, nurses, allied health professionals, and patient consumers. For healthcare professionals - namely clinicians, nurses, and allied health staff - the inclusion criterion is current or recent experience providing care within the GARU setting. Individuals not directly involved in clinical care will be excluded. To ensure maximum variation sampling, participants will be purposively selected based on discipline and years of experience. Patient consumers will include current inpatients or individuals recently discharged from the GARU within the past six months. Eligible participants must be over 18 years of age and have the capacity and willingness to provide informed consent. Phase 2 inclusion criteria: Willing GARU inpatients and staff able to provide informed consent.
Exclusion criteria
Phase 1 exclusion criteria: Exclusion criteria include lack of fluency in English where an interpreter is required but not available. Variation among consumers will be sought based on key demographic and clinical characteristics to ensure a diversity of perspectives. Phase 2 exclusion criteria: GARU inpatients not fluent in English for whom an interpreter is required but not available, patients <18 years of age, and patients with significant cognitive impairment precluding participation Intervention.