Researching Efficient Approaches to Delirium Identification-Sustaining Effective Translation

NCT05915377 | Recruiting DMC

• 1 other identifier: 10658578
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this step-wedge trial is to test the implementation of daily nurse screening for delirium in routine care and its impact on outcomes and complications in hospitalized older adults admitted to 6 general medicine/surgery units at 3 hospitals in Pennsylvania and Massachusetts. The main question\[s\] it aims to answer are:

• 1\. To test the fidelity, accuracy, and durability of implementing daily nurse screening for delirium using the UB-CAM in routine care.
• 2\. To evaluate the impact of UB-CAM delirium screening on patient and care partner centered outcomes assessed at one month follow-up interviews 3. To evaluate the impact of UB-CAM screening on rates of delirium complications (falls, pressure injury, aspiration) and adverse delirium management (psychoactive medication use, restraint use). Participants (patients) will be assessed for delirium on study days 1, 2 and 3 (or until hospital discharge) and will be asked basic demographics. These patients will be contacted by phone 1 month after enrollment to collect information about inpatient facility use and to administer the Delirium Burden Patient Scale. Participants (care partners) will be interviewed at the patient's discharge to complete the Alzheimer's Disease-8 scale. These care partners will be contacted by phone 1 month after enrollment to complete the Delirium Burden Caregiver Scale and to complete a Qualitative Interview which includes questions about communication and collaboration.

Conditions

Delirium; Delirium in Old Age; Delirium With Dementia; Delirium Superimposed on Dementia

Keywords

Delirium; Confusion; Altered Mental Status; Acute Metabolic Encephalopathy; Implementation; Screening; Acute Care; Electronic Health Record

Outcome Measures

Primary Outcomes (3)

• Aim 1: To Find the Percent Agreement Between the Nurse UB-CAM Screen and the Reference Standard Delirium Assessment (RSDA)

  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.

  Three consecutive hospital days

• Aim 2: To Measure Healthy Days at Home (HDAH) as Defined by the Medicare Payment Advisory Commission

  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

  One month post-hospital

• Aim 3: To Measure Three Complications of Delirium

  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.

  From hospital admission through discharge, an average of 1 week

Secondary Outcomes (3)

• Aim 1: Fidelity: To Find the Percent of Eligible Days With At Least One Completed Nurse Delirium Screen

  From hospital admission through discharge, an average of 1 week

• Aim 2: Patient/Family Care Partner Distress

  One month after hospital discharge

• Aim 3: Rate of Use of Physical Restraints or Use of Antipsychotic Medications

  From hospital admission through discharge, an average of 1 week

Other Outcomes (1)

• Aim 2: Patient/Care Partner Perceptions of Communication, Collaboration (Qualitative)

  One month after hospital discharge

Study Arms (2)

Readi Set Go Patient Oriented Sample

EXPERIMENTAL

Hospitalized older adults at risk of developing delirium providing informed consent will have the UB-CAM integrated into the electronic health record and RSDA delirium assessments.

Other: READI-SET GO UB-CAM delirium screening into EHR

Readi Set Go Administrative Sample

EXPERIMENTAL

All patient admitted to the study wards for the duration of the study will have the UB-CAM integrated into the electronic health record

Other: READI-SET GO UB-CAM delirium screening into EHR

Interventions

READI-SET GO UB-CAM delirium screening into EHR OTHER

UB-CAM Delirium screening tool integrated into EHR with education on best practices for delirium management

Readi Set Go Administrative Sample; Readi Set Go Patient Oriented Sample

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to communicate adequately in English
• Admitted for terminal care

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: collaborator
• Penn State Health Milton S Hershey Medical Center: collaborator
• Penn State University: lead
• Mount Nittany Medical Center: collaborator

Study Sites (2)

Beth Israel Deaconness Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Mount Nittany Medical Center

State College, Pennsylvania, 16801, United States

RECRUITING

MeSH Terms

Conditions

Delirium; Confusion

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Donna M Fick, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

• Edward R Marcantonio, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna M Fick, PhD

CONTACT

814-574-1716; dmf21@psu.edu

Kerry A Palihnich, BA

CONTACT

617-667-0132; kpalihni@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Partial masking of outcomes assessors and providers
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Step Wedge

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 23, 2023
• Study Start: April 3, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 1 year of publication of the study results. It will be available indefinitely.
• Access Criteria: To be determined at a later date

Locations

US (2)