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The staged implementation facilitated by the stepped wedge design is particularly helpful when simultaneous rollout of an intervention to all clusters is impractical, for example, for logistical or financial reasons. This trial design is used to evaluate interventions whose effects are predicted to be more beneficial than harmful, especially those interventions embedded in daily clinical practice.25 Stepped wedge designs are increasingly used in trials of interventions in acute care.26�C29 Figure?3 HEADS-UP (Hospital Event Analysis Describing Significant Unanticipated Problems) stepped wedge cluster design. The order in which clusters receive the intervention will be guided by logistical restrictions, and the de facto recognition of clinicians enthusiastic to introduce HEADS-UP to their wards. Although cluster randomisation (randomising the order in which the clusters receive the intervention) would be preferable, it is important to recognise the impact of willing early adopters who then lead their colleagues in implementing the intervention.30 They are likely to participate more extensively and follow through more rigorously and enthusiastically with the intervention than units at later stages of the intervention diffusion.31 Sufficient leadership and support from these early adopters will be needed to maximise the use of HEADS-UP in all the desired areas, much as the introduction of surgical checklists, for instance, has historically relied on strong clinical leadership.32 HEADS-UP is introduced to new clusters at two-monthly intervals. The study is conducted at two sites. The first is a university-associated community general hospital. Clusters from this site are generated from the acute admissions and downstream medical (gastroenterology, respiratory and geriatric) wards. Each cluster comprises clinical areas that are physically linked, served by the same medical team, or both. This will help to limit contamination between groups. The second site is an academic hospital, where HEADS-UP will be implemented within the geriatric wards. Study population The study focuses on adult medical patients admitted to study wards between 2013 and 2015. To isolate the effect of the intervention, patient-level exclusion criteria will include: Time spent on the specified ward comprising less than 50% of the total inpatient stay; Discharge to a new skilled care facility or other hospital (ie, not the NVP-BGJ398 purchase patient's address at the time of admission; discharge to a new facility typically incurs substantial delays, outside of the ward team's control); Multiple intrahospital ward transfers. A single transfer from the initial admissions unit to a downstream medical ward is permitted.