Implementation of delirium management during the pandemic: lessons learned

Abstract

Background During the covid-19 pandemic, a non-funded, nurse-led quality improvement project on delirium management was in progress on four Stroke Units (SU). Two sites experienced pandemic-related delays; we set out to learn lessons based on the impact for delivering multicentre trials. Methods Secondary analysis of a prospective quality improvement project. We compared data quality from centres with vs. without delay. Unplanned modifications in study management were classified as a) fatal modifications (ending the study), b) serious modifications (requiring a revision of the registration and/or ethic approval, c) moderate modifications (revising study management), d) minor modifications (improving study performance). Local study coordinators summarised lessons learned. Results The study had an overall delay of 14 months. Centres without delay delivered better data quality and had less loss of patients due to missing primary outcome data in 0.3% vs 28.8% in centres with delay (p<0.001). There were no fatal modifications, two serious (exchange of study centre, adding new outcome parameters), six moderate (e.g. delayed start in two centres, change from in-person to virtual meetings), and one minor modification (four local study coordinators taking parental leave). Lessons learned were frequent communication with study coordinators, attention to data quality, protocolisation of recruitment rates, and adapted education in quality improvement projects. Conclusions Pandemic-related disruption can be substantial, with poorer data quality, but only in a few cases were registration and/or ethic approval modifications required. Facilitators are flexible, including changed time frames, frequent virtual communication, and critical reflection.