Implementation Outcome Assessments of the Emergency Department Delirium Screening and Detection Program (ED-DDP)

January 29, 2026 updated by: Northwell Health

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

Detailed Description

Grounded in the RE-AIM framework, investigators will use mixed methods to conduct implementation outcome assessments of the ED-DDP for champions and nurses. A multimodal approach, using training logs, tele-observations, and EHR data, will assess quantitative outcomes during implementation/intervention periods: Reach (training completion), Efficacy (accurate screening tool use), Adoption (screening rates), and Implementation (fidelity/time of program delivery). Investigators will conduct semi-structured interviews (intervention period) to assess and explain: successes and challenges of training completion (Reach) and Adoption of delirium screening; adaptations made to ED DDP delivery (Implementation); and plan for Maintenance.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Manhasset, New York, United States, 11030
        • Feinstein Institutes for Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accurate Delirium Screening by Emergency Department (ED) Nurses (RE-AIM: Efficacy)
Time Frame: Intervention period (3-9 months post program implementation)
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.
Intervention period (3-9 months post program implementation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Delirium Champions Who Complete Training (RE:AIM: Reach)
Time Frame: Implementation period (3 months)
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.
Implementation period (3 months)
Proportion of Emergency Department Nurses Who Complete Training (RE-AIM: Reach)
Time Frame: Implementation period (3 months)
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.
Implementation period (3 months)
Proportion of Nurses Who Screen Eligible Patients (REAIM: Adoption)
Time Frame: Intervention period (3-9 months post implementation)
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.
Intervention period (3-9 months post implementation)
Proportion of Training Program Components That Adhered to ED-DDP Protocol (REAIM: Implementation/Fidelity)
Time Frame: Implementation period (3 months)
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.
Implementation period (3 months)
Time Required to Train Delirium Champions and Nurses (REAIM: Implementation/Time)
Time Frame: Implementation period (3 months)
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).
Implementation period (3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Liron Sinvani, MD, Northwell Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Actual)

January 12, 2024

Study Completion (Actual)

October 8, 2024

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 1, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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