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NCT05638945 · ClinicalTrials.gov registry record · NA
Determining the Preliminary Efficacy of the Emergency Department Delirium Screening and Detection Program
A NA study, sponsored by Northwell Health.
- Completed
- Registry status
- NA
- Development phase
- 3,000
- Enrollment target
NCT05638945: Completed NA study, sponsored by Northwell Health.
NCT05638945 is a NA study that has completed, run by Northwell Health. The registered enrollment target is 3,000 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (114% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05638945, a NA study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 3,000 participants
- Enrollment target
Study Summary
Delirium occurs in up to 20% of older adults presenting to the Emergency Department (ED) and is associated with poor outcomes. Failure to identify patients with ED delirium not only prevents initiation of mitigation strategies, but is also a barrier to advancing the field in terms of evaluating management and clinical outcomes. This project studies the potential of an ED Delirium Detection Program (ED-DDP), developed to address the need for consistent and accurate ED delirium detection. This research will have two objectives: * Aim 1 will conduct a pilot stepped wedge cluster randomized trial (SW-CRT) of the ED-DDP across 3 diverse EDs to determine preliminary efficacy of the detection training program, and * Aim 2 will use a mixed methods approach to assess RE-AIM implementation outcomes (Reach, Efficacy, Adoption, Implementation, and Maintenance) of the training program. Aim 1 will consist of a multicomponent 1-day delirium champion workshop where the training is delivered, real-time direct observation/training of champions via telehealth, practical training of nurses throughout each ED by champions, and patient chart review. In Aim 2, the investigators will assess implementation outcomes using training logs, tele-observation, interviews with champions and nurses, and electronic medical record screening. The overarching aim of this proposal is to determine the preliminary efficacy of the training program for improving ED delirium screening, detection, and management in older adults, while also evaluating implementation outcomes of the program for champions/nurses. The investigators will use findings from this study to inform a full-scale SW-CRT to evaluate the impact of the program on patient outcomes at Northwell Health. The long-term goal of this study is to implement and disseminate a comprehensive ED-DDP that will improve screening, detection, and management of ED delirium in older adults.
Primary Outcome
Delirium detection is defined as the change in the proportion of documented delirium (i.e., the word delirium appears in the chart or there is a positive brief confusion assessment method \[bCAM\]) over time from baseline to 9 months (every 3 months), among patients with delirium. To identify the sample of patients with delirium, trained research staff will use a validated approach to conduct retrospective in-depth chart reviews to assess for ED presence of delirium (sensitivity 74%, specificity
Interventions
- BEHAVIORAL ED Delirium Screening and Detection Program (ED-DDP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2022-11-28 |
| Est. Completion | 2024-10-08 |
| Phase | NA |
What the finished NCT05638945 record still lists
NCT05638945 is an interventional study that assigns participants to a tested intervention. Its 3,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (114% higher).
The record links to 0 conditions, and to 1 intervention - of which ED Delirium Screening and Detection Program (ED-DDP) is the first listed.
NCT05638945 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05638945 about?
NCT05638945 is a clinical study titled "Determining the Preliminary Efficacy of the Emergency Department Delirium Screening and Detection Program". Delirium occurs in up to 20% of older adults presenting to the Emergency Department (ED) and is associated with poor outcomes. Failure to identify patients with ED delirium not only prevents initiation of mitigation strategies, but is also a barrier to advancing the field in terms of evaluating mana...
What is the current status of trial NCT05638945?
This trial is currently completed. It is a NA study. The enrollment target is 3,000 participants. The study started on 2022-11-28. Estimated completion is 2024-10-08.
What interventions are being tested in trial NCT05638945?
The interventions under investigation include: ED Delirium Screening and Detection Program (ED-DDP) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05638945?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05638945's enrollment target sits among peer trials
3,000 40th of 2000 higher than 1,959 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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