Researching Efficient Approaches to Delirium Identification-Sustaining Effective Translation

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Penn State University
Study ID
NCT05915377
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Apr 3, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
1,050 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

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

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconness Medical CenterBostonMassachusetts02215
Edward Marcantonio, MD
Mount Nittany Medical CenterState CollegePennsylvania16801
Donna Fick, PhD
814 574 1716

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