Do Digital Handover Checklists Influence the Clinical Outcome Parameters of Intensive Care Unit Patients? A Randomized Controlled Pilot Study

Background: Clinical handovers have been identified as high-risk situations for medical treatment errors. It has been shown that handover checklists lead to a reduced rate of medical errors and mortality. However, the influence of handover checklists on essential patient outcomes such as prevalence of sepsis, mortality, and length of hospitalization has not yet been investigated in a randomized controlled trial (RCT). Objectives: The aim of the present pilot study was to estimate the effect of two different handover checklists on the 48 h sepsis-related organ failure assessment (SOFA) score and the feasibility of a respective clinical RCT. Methods: Outcome parameters and feasibility were investigated implementing and comparing an intervention with a control checklist. Design: Single center two-armed cluster randomized prospective crossover pilot study. Setting: The study took place over three 1-month periods in an intensive care unit (ICU) setting at the University Hospital Aachen. Patients/Participants: Data from 1,882 patients on seven ICU wards were assessed, of which 1,038 were included in the analysis. Intervention: A digital standardized handover checklist (ISBAR(3)) was compared to a control checklist (VICUR). Main Outcome Measures: Primary outcome was the 2nd 24 h time window sepsis-related organ failure assessment (SOFA) score. Secondary outcomes were SOFA scores on the 3rd and 5th 24 h time window, mortality, reuptake, and length of stay; handover duration, degree of satisfaction, and compliance as feasibility-related outcomes. Results: Different sepsis scores were observed only for the 1st 24 h time window after admission to the ICU, with higher values for ISBAR(3). With respect to the patient-centered outcomes, both checklists achieved similar results. Average handover duration was shorter for VICUR, whereas satisfaction and compliance were higher for ISBAR(3). However, overall compliance was low (25.4% for ISBAR(3) and 15.8% for VICUR). Conclusions: Based on the results, a stratified randomization procedure is recommended for following RCTs, in which medical treatment errors should also be investigated as an additional variable. The use of control checklists is discouraged due to lower acceptance and compliance among healthcare practitioners. Measures should be undertaken to increase compliance with the use of checklists. Clinical outcome parameters should be carefully selected. Trial Registration: ClinicalTrials.gov, Identifier [NCT03117088]. Registered April 14, 2017.