Abstract

BackgroundPatient safety is threatened when early signs of clinical deterioration are missed or not acted upon. This research began as a clinical-academic partnership established around a shared concern of nursing physical assessment practices on general wards and delayed recognition of clinical deterioration. The outcome was the development of a complex intervention facilitated at the ward level for proactive nursing surveillance. MethodsThe evidence-based nursing core assessment (ENCORE) trial was a pragmatic cluster-randomised controlled trial. We hypothesised that ward intervention would reduce the incidence of patient rescue events (medical emergency team activations) and serious adverse events. We randomised 29 general wards in a 1:2 allocation, across 5 Australian hospitals to intervention (n = 10) and usual care wards (n = 19). Skilled facilitation over 12 months enabled practitioner-led, ward-level practice change for proactive nursing surveillance. The primary outcome was the rate of medical emergency team activations and secondary outcomes were unplanned intensive care unit admissions, on-ward resuscitations, and unexpected deaths. Outcomes were prospectively collected for 6 months following the initial 6 months of implementation. Analysis was at the patient level using generalised linear mixed models to account for clustering by ward. ResultsWe analysed 29,385 patient admissions to intervention (n = 11,792) and control (n = 17,593) wards. Adjusted models for overall effects suggested the intervention increased the rate of medical emergency team activations (adjusted incidence rate ratio 1.314; 95 % confidence interval 0.975, 1.773), although the confidence interval was compatible with a marginal decrease to a substantial increase in rate. Confidence intervals for secondary outcomes included a range of plausible effects from benefit to harm. However, considerable heterogeneity was observed in intervention effects by patient comorbidity. Among patients with few comorbid conditions in the intervention arm there was a lower medical emergency team activation rate and decreased odds of unexpected death. Among patients with multimorbidity in the intervention arm there were higher rates of medical emergency team activation and intensive care unit admissions. ConclusionTrial outcomes have refined our assumptions about the impact of the ENCORE intervention. The intervention appears to have protective effects for patients with low complexity where frontline teams can respond locally. It also appears to have redistributed medical emergency team activations and unplanned intensive care unit admissions, mobilising higher rates of rescue for patients with multimorbidity. Trial registration numberACTRN12618001903279 (Date of registration: 22/11/2018; First participant recruited: 01/02/2019).

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