Researching Delirium Identification in Older Hospitalized Adults

This study is looking at how well a daily screening tool called UB-CAM can help nurses identify delirium (a sudden state of confusion) in older adults who are in the hospital. The study will also see if using this tool changes patient outcomes and complications. You might be able to join if you are 70 or older, are admitted to a general medicine service, and are expected to stay in the hospital for at least three days. The study aims to see if the UB-CAM tool is accurate and if it helps patients have more "healthy days at home" after leaving the hospital, and if it reduces delirium-related complications. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 1050 participants. It uses a stepped-wedge design, meaning the UB-CAM screening will be introduced to different hospital units over time.
What's involved
Participants will have daily delirium screening using the UB-CAM tool as part of their routine care. Some participants will also have additional delirium assessments and follow-up interviews one month after leaving the hospital.
Compensation
Not stated in the trial record.
Follow-up
Patient outcomes will be measured one month after hospital discharge. Complications of delirium will be measured from hospital admission through discharge.

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NCT05915377

Researching Efficient Approaches to Delirium Identification-Sustaining Effective Translation

Recruiting
NAAges 70+InterventionalScreening
Penn State University
~1,050 participants
Updated 2026-02-20 on ClinicalTrials.gov
What's tested:READI-SET GO UB-CAM delirium screening into EHR

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Aim 1: To Find the Percent Agreement Between the Nurse UB-CAM Screen and the Reference Standard Delirium Assessment (RSDA)
Measured over Three consecutive hospital days
+2 more outcomes measured
Delirium
Delirium in Old Age
Delirium With Dementia
Delirium Superimposed on Dementia
2 sites across 2 states
Massachusetts1
Pennsylvania1
  • Donna M Fick, PhD · PRINCIPAL_INVESTIGATOR · Penn State University
  • Edward R Marcantonio, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center

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Eligibility criteria

Inclusion

General medicine (hospitalist) service
Age 70 or older
Expected hospital length of stay of 3 or more days

Exclusion

Inability to communicate adequately in English
Admitted for terminal care
  • Aim 1: To Find the Percent Agreement Between the Nurse UB-CAM Screen and the Reference Standard Delirium Assessment (RSDA)Three consecutive hospital days

    Accuracy is defined as the percent agreement between the nurse UB-CAM screen and the RSDA. While false negatives (low sensitivity) are most concerning since delirium is missed, false positives are problematic as well, as they lead to false labeling and unnecessary workups, which burden both patients and hospital staff. In subset analyses, the investigators will also consider sensitivity (among all RSDA positives) and specificity (among all RSDA negatives). Our sample size of 2360 assessments and target 20% delirium positivity rate (achieved in READI), will allow both analyses of accuracy, and subset analyses of sensitivity and specificity. Since each patient will contribute 1-3 assessments, the investigators will account for clustering in the analysis, as the investigators did in READI.11 Clinician identification of delirium during the "pre" period will be captured by EMR documentation. Absence of such documentation will be considered negative identification.

  • Aim 2: To Measure Healthy Days at Home (HDAH) as Defined by the Medicare Payment Advisory CommissionOne month post-hospital

    Our patient/care partner focus group told us that if hospitalized, their primary goal was to return home as soon as possible, and stay home. Healthy Days at Home (HDAH) is a measure developed in conjunction with the Medicare Payment Advisory Commission and is calculated: HDAH = 30 days - (Index hospitalization days + Mortality Days + Skilled Nursing Facility Days + Inpatient Rehabilitation Day + Long Term Hospital Days + Hospital Transfer/Readmission Days + Subsequent Emergency Department Visit Days) The investigators will obtain information on hospital length of stay and discharge disposition from the EMR. The investigators will get information on subsequent inpatient facility stays, readmissions, and ED

  • Aim 3: To Measure Three Complications of DeliriumFrom hospital admission through discharge, an average of 1 week

    This outcome includes 3 delirium-related adverse events-falls, severe pressure injury, and aspiration pneumonia. Each occurs in 2-4% of all hospital discharges, but much more frequently in patients with delirium (relative risk for falls among delirious patients may be \> 20). Each prolongs length of stay, and increases need for post-discharge facility use, patient and care partner distress, and mortality. The investigators will design our UB-CAM app such that positive screens will present management tips that will address preventive strategies to reduce these complications. For instance, if a patient screens positive for delirium, feeding should occur out of bed or with the head of the bed at 90 degrees, reducing risk of aspiration. The investigators will identify these complications using incident reports (falls, pressure injury) and ICD discharge codes for each outcome, plus "not present on admission" to ensure these were not pre-existing conditions.