- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05606328
Implementation Outcome Assessments of the Emergency Department Delirium Screening and Detection Program (ED-DDP)
Improving Delirium Screening and Detection for Older Adults Presenting to the Emergency Department (ED): A Novel ED 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 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Manhasset, New York, United States, 11030
- Feinstein Institutes for Medical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Nurse educators, managers, or bedside nurses self-identified or recommended by emergency department (ED) leadership to volunteer as a program site champion
- Primarily working at a participating ED site
- Commitment to program participation
Exclusion Criteria:
- Unable to meet program requirements, including attending champion workshop, agreement to observation and training via telehealth, and commitment to train department staff
- Does not primarily work in the ED
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Implementation Period
ED leadership at each site will identify 5-10 delirium champions (nurse educators and managers, bedside nurses) based on their interest in delirium and commitment to program participation, including training of nurses by champions.
The implementation period will take place over a period of 3 months.
No data analysis will take place during the implementation period.
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Champions will participate in a 1-day workshop, consisting of patient testimonials, small group discussions, delirium and screening tool use (didactics), and role-playing.
Following the workshop, champions will receive 3 tele-training sessions; 2 to provide direct observation/feedback while the champion performs a bedside delirium screen, and 1 to provide direct observation/feedback of the champion providing training to the nurse.
Once delirium champions complete training, they will provide bedside delirium training for all ED nurses.
No adaptations to the ED-DDP will occur between implementation sites and no data will be collected during implementation phases.
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No Intervention: Intervention Period
The intervention period will take place 3-9 months after implementation of the ED-DDP program over a 15 month period, depending on when a site is randomized to receive the ED-DDP intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Accurate Delirium Screening by Emergency Department (ED) Nurses (RE-AIM: Efficacy)
Time Frame: Intervention period (3-9 months post program implementation)
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Tele-observations will be used to asses screening accuracy, defined as the proportion of nurses who score at least 80% accuracy on the brief confusion assessment method (bCAM) use using a validated Spot Check Form.
The investigators will observe a random sample of nurses (N=30, 10 at each ED site) performing a delirium screen in real-time.
A successful outcome will be considered if computed proportion of nurses accurately using the bCAM tool is 80% or higher.
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Intervention period (3-9 months post program implementation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proportion of Delirium Champions Who Complete Training (RE:AIM: Reach)
Time Frame: Implementation period (3 months)
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Champion training logs will be used to determine the proportion of champions who complete training (1-day workshop and 3 tele-training sessions) at each emergency department site.
A successful outcome will be considered if computed proportion is 80% or higher.
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Implementation period (3 months)
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Proportion of Emergency Department Nurses Who Complete Training (RE-AIM: Reach)
Time Frame: Implementation period (3 months)
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Emergency department nurse training logs will be used to determine the proportion of nurses who complete at least 1 training session with a delirium champion at each ED site.
A successful outcome will be considered if computed proportion is 80% or higher.
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Implementation period (3 months)
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Proportion of Nurses Who Screen Eligible Patients (REAIM: Adoption)
Time Frame: Intervention period (3-9 months post implementation)
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Electronic health record (EHR) data will be used to determine the proportion of nurses who document delirium screening in at least 80% of eligible patients.
A successful outcome will be considered if computed proportion is 80% or higher.
Data is reported as the number of patient records reviewed during the intervention period that contained a delirium screening by a emergency department nurse.
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Intervention period (3-9 months post implementation)
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Proportion of Training Program Components That Adhered to ED-DDP Protocol (REAIM: Implementation/Fidelity)
Time Frame: Implementation period (3 months)
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Training logs of delirium champions and ED nurses will be used to determine the proportion of training components (workshop, tele-training sessions, and bedside training of nurses by champions) that adhered to ED-DDP protocol.
A successful outcome will be considered if computed proportion is 80% or higher.
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Implementation period (3 months)
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Time Required to Train Delirium Champions and Nurses (REAIM: Implementation/Time)
Time Frame: Implementation period (3 months)
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Data is reported as total number of days necessary to train 80% of nurses in the ED site.
Training logs of delirium champions and ED nurses will be used to determine the time required to complete champion and ED nurse training.
A successful outcome will be considered if 80% of delirium champion and ED nurses complete training within the implementation period (fewer than 90 days).
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Implementation period (3 months)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Liron Sinvani, MD, Northwell Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-0681
- R21AG075230 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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