Implementation Outcome Assessments of the Emergency Department Delirium Screening and Detection Program

NCT05606328 | Completed Results

• 2 other identifiers: 22-0681R21AG075230
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium

Keywords

Delirium Screening; Delirium Detection; Emergency Department; Older Adults

Outcome Measures

Primary Outcomes (1)

• Accurate Delirium Screening by Emergency Department (ED) Nurses (RE-AIM: Efficacy)

  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 Outcomes (5)

• Proportion of Delirium Champions Who Complete Training (RE:AIM: Reach)

  Implementation period (3 months)

• Proportion of Emergency Department Nurses Who Complete Training (RE-AIM: Reach)

  Implementation period (3 months)

• Proportion of Nurses Who Screen Eligible Patients (REAIM: Adoption)

  Intervention period (3-9 months post implementation)

• Proportion of Training Program Components That Adhered to ED-DDP Protocol (REAIM: Implementation/Fidelity)

  Implementation period (3 months)

• Time Required to Train Delirium Champions and Nurses (REAIM: Implementation/Time)

  Implementation period (3 months)

Study Arms (2)

Implementation Period

EXPERIMENTAL

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.

Behavioral: Emergency Department Delirium Screening and Detection Program (ED-DDP)

Intervention Period

NO INTERVENTION

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.

Interventions

Emergency Department Delirium Screening and Detection Program (ED-DDP) BEHAVIORAL

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.

Implementation Period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Feinstein Institutes for Medical Research

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Delirium; Emergencies

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Liron Sinvani, MD
• Organization: Northwell Health

ldanay@northwell.edu

646-864-6020

Study Officials

• Liron Sinvani, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a pilot stepped wedge cluster randomized trial (SW-CRT) of three diverse emergency department (EDs) randomized to receive the intervention at 3-month intervals over a 15-month period. Time of crossover from the control to intervention period will be unidirectional, and each crossover sequence will allow for a 3-month implementation period where data will not be collected.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 4, 2022
• Study Start: February 28, 2023
• Primary Completion: January 12, 2024
• Study Completion: October 8, 2024
• Last Updated: January 30, 2026
• Results First Posted: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)