Prospective Evaluation of the Automated CAM-ICU-7: A Digital Marker for Delirium Severity in the ICU
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PROJECT SUMMARY/ABSTRACT This resubmitted R01 application outlines a prospective, longitudinal cohort study to test a passive digital marker for delirium severity (PDM-Del) to ensure it is a consistent and valid measurement of delirium severity in critically ill, aging adults. This proposal aligns with updated agency priorities listed in PA-25-301, including research to foster innovative applications to improve health. Delirium is a modifiable risk factor for AD/ADRD. This application aims to evaluate the validity of an automated, repeated measurement (PDM-Del) for delirium detection and severity measurement, thus providing just-in-time information to clinicians to initiate early mitigation strategies. Delirium, an acute and fluctuating disturbance in consciousness and cognition, impacts 40-50% of mechanically ventilated, intensive care unit (ICU) adults. Severe delirium accelerates the rate of global cognitive decline, leading to an increased risk of Alzheimer’s Disease and Related Dementias (AD/ADRD). Therefore, reducing delirium severity holds great promise in decreasing ADRD burden. Unfortunately, delirium and its severity are seldom monitored in the ICU due to a myriad of reasons, including nurse-reported difficulty with manual delirium assessments. Accurate and timely detection of delirium and measurement of delirium severity is urgently needed to implement the proper, evidence-based treatment at the right time. To begin to fill this significant gap in clinical care, we developed the PDM-Del based on the widely validated CAM-ICU (detection) and our validated delirium severity instrument entitled the CAM-ICU-7 (severity). Both tools require clinicians to administer additional tests. Our PDM-Del requires zero additional time for data collection because it uses already collected (passive) data captured by the electronic health record (EHR). Like a continuous vital sign, the PDM-Del would provide immediate and actionable feedback to clinicians on the status of delirium, and its severity, in ICU patients. Aging adult (>50 years old) patients who are anticipated to remain in the ICU for >24 hours will be prospectively recruited upon their admission to the ICUs at Mayo Clinic, Rochester, MN, and the general ICU at Eskenazi Health Hospital in Indianapolis, IN. The study team will administer reference standard delirium and delirium severity assessments three times per day (concurrent validity), and neuropsychological testing at 90-days post- hospital discharge (predictive validity). As 1 in 3 delirium survivors will experience cognitive decline following their ICU stay23, it is important to confirm that the PDM-Del can identify those at-risk individuals. The proposed study aims to 1) To assess the internal consistency of PDM-Del, its agreement with study team administered CAM-ICU-7 (reference standard), and its sensitivity to change among critically ill aging adults; and 2) To assess the predictive validity of the PDM-Del by investigating its association with ICU length of stay, hospital length of stay, and global cognition 90-days post hospital discharge. Delirium is a modifiable risk factor for AD/ADRD; therefore, the mitigation of delirium severity is crucial to ameliorating AD/ADRD risk.
