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 — OTHERUB-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 SampleHospitalized 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 SampleAll 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
- Donna M Fick, PhD814-574-1716
- Kerry A Palihnich, BA617-667-0132
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Beth Israel Deaconness Medical Center | Boston | Massachusetts | 02215 | Edward Marcantonio, MD |
| Mount Nittany Medical Center | State College | Pennsylvania | 16801 | Donna Fick, PhD 814 574 1716 |
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