Effect of the clinical decision support system on clinical outcomes of delirium in hospitalized older adults: study protocol for a pair-matched, parallel,cluster randomized controlled trial

Abstract

Abstract Background: Prompt recognition of delirium is the first key step in its proper management. Previous study has demonstrated delirium screening using usual paper version assessment tool by nurses had no effect on clinical outcomes. Clinical decision support systems have been demonstrated to improve the adherence and clinical outcomes of patients. Therefore, We developed a clinical decision support system (3D-DST) based on the usual paper version (3-minute diagnostic interview for CAM-defined delirium, 3D-CAM), which was developed for the assessment of delirium in older adults with high usability and accuracy. However, there is no high quality evidence exists on the effectiveness of a 3D-DST in improving outcomes of older adults compare to usual paper version. Methods: A pair-matched, open-label, parallel, cluster randomized controlled trial following the SPIRIT checklist. Older patients aged 65 years or older admitted to four medical wards of a geriatric hospital will be invited to participate in the study. Prior to the study, delirium prevention and treatment interventions will be delivered to nurses in both the intervention and control groups. The nurses in the intervention group will perform routine delirium assessment on the included elderly patients with 3D-DST, while the nurses in the control group will perform daily delirium assessment with usual paper version. Enrolled patients will be assessed twice daily for delirium by a nursing researcher using 3D-DST for clinical outcomes. The primary outcome is delirium duration. The secondary outcomes are delirium severity, incidence, length of stay, in-hospital mortality, adherence to delirium assessment, prevention and treatment of medical staff. Discussion: This study willincorporate the 3D-DST into clinical practice for delirium assessment. If our study will demonstrate that 3D-DST will improve adherence with delirium assessment and clinical outcomes in older patients, it will provide important evidence for the management of delirium in the future. Trial registration: ClinicalTrials.gov, Identifier: ChiCTR1900028403.