Protocol for Evaluation of the CONCERN Clinical Decision Support Early Warning System: A Cluster Randomized Pragmatic Clinical Trial (Preprint)

BACKGROUND The overarching goal of the COmmunicating Narrative Concerns Entered by RNs (CONCERN) study is to implement and evaluate an early warning score system which provides clinical decision support (CDS) in electronic health record systems. The CONCERN CDS uses nursing documentation patterns as indicators of nurses’ increased surveillance to predict when patients are at risk of clinical deterioration. OBJECTIVE The objective of this cluster randomized pragmatic clinical trial is to evaluate the effectiveness and usability of the CONCERN CDS system at two different study sites. The specific aim is to decrease hospitalized patients’ negative health outcomes (in-hospital mortality, length of stay, cardiac arrest, unanticipated ICU transfers, and 30-day hospital readmission rates). METHODS A multiple time-series intervention consisting of three phases will be performed through a one-year period during the cluster randomized pragmatic clinical trial. It deals with a series of processes from system release to evaluation. The system release includes CONCERN CDS implementation and user training. Then, a mixed methods approach will be conducted with end-users to assess the system and clinician perspectives. RESULTS Study results are expected in 2022. CONCLUSIONS The CONCERN CDS will increase team-based situational awareness and shared understanding of patients predicted to be at risk for clinical deterioration in need of intervention to prevent mortality and associated harm. CLINICALTRIAL ClinicalTrials.gov | Identifier: NCT03911687