Recruiting

Observational Study

Sponsor:

Penn State University

Code:

NCT05915377

Conditions

Delirium

Delirium in Old Age

Delirium With Dementia

Delirium Superimposed on Dementia

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

READI-SET GO UB-CAM delirium screening into EHR

Study Details

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

Study ID

NCT05915377

Start date

Apr 3, 2024

Status verified date

Feb, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

1050 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Readi Set Go Patient Oriented Sample

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.

experimental: Readi Set Go Administrative Sample

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

Interventions

READI-SET GO UB-CAM delirium screening into EHR

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

Primary outcome measure

  • Aim 1: To Find the Percent Agreement Between the Nurse UB-CAM Screen and the Reference Standard Delirium Assessment (RSDA) [ Time Frame: Three consecutive hospital days ]
  • Aim 2: To Measure Healthy Days at Home (HDAH) as Defined by the Medicare Payment Advisory Commission [ Time Frame: One month post-hospital ]
  • Aim 3: To Measure Three Complications of Delirium [ Time Frame: From hospital admission through discharge, an average of 1 week ]

Central Contacts and Locations

Central contacts

Locations

Beth Israel Deaconness Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Mount Nittany Medical Center

Recruiting

State College, Pennsylvania, United States, 16801

Contacts

Donna Fick, PhD

814 574 1716

More Information

Sponsor

Penn State University

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2026-02-20.