Determining the Preliminary Efficacy of the Emergency Department Delirium Screening and Detection Program

NCT05638945 | Completed Results

• 2 other identifiers: 22-0681-350CDR21AG075230
• Study Type: interventional
• Target: 3,000
• 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)

• Proportion of Positive Delirium Screens Among Those With Delirium

  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 83%) among a randomly sampled population of 3,000 patients (1,000 patients per ED or 250 patients per ED per data collection period). Two delirium experts will perform chart checks and adjudicate any uncertain cases. To assess change over time, data will be reported as total charts with positive delirium screens pre ED-DDP (Control Period) and post ED-DDP (Intervention Period).

  Change from baseline to 9 months

Secondary Outcomes (3)

• Proportion of Eligible Patients Who Receive Delirium Screening

  Change from baseline to 9 months

• Proportion of Eligible Patients Who Receive Safety Precautions

  Change from baseline to 9 months

• Proportion of Eligible Patients Who Receive Physical and Chemical Restraints for Behavioral Symptoms

  Change from baseline to 9 months

Study Arms (2)

Control Period

NO INTERVENTION

Delirium screening on initial assessment of all older adults presenting to the ED is considered standard of care, but not mandated. All health system EDs have access to a validated EHR integrated delirium screening tool (brief confusion assessment method, or bCAM) and all ED nurses have received training on bCAM use. The bCAM tool is an open parameter in the EHR. For positive bCAM screens, a message is displayed, "This patient has delirium, alert medical team, identify/ treat the underlying cause, ensure patient safety, nonpharmacologic interventions as first line, and avoid physical and chemical restraints". The control period will include chart reviews of patient visits occurring before implementation of the ED-DDP program.

Intervention Period

EXPERIMENTAL

ED leadership at each site have identified 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 intervention period will include chart reviews of patient visits occurring after implementation of the ED-DDP program.

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

Interventions

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

The intervention arm will have standardized delirium screening by nurses using the brief confusion assessment method (bCAM) in the EHR and will receive the ED-DDP. The ED-DDP will consist of: 1) a multicomponent 1-day delirium champion workshop; 2) real-time direct observation/training via telehealth (tele-training); and 3) training of nurses by champions. 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.

Intervention Period

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Presenting to a participating study site emergency department (ED) during control or intervention periods
• Survival to ED discharge or to hospital admission

You may not qualify if:

• Presenting to a participating study site ED during ED-DDP implementation periods

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

646-877-7393

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: December 6, 2022
• Study Start: November 28, 2022
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: April 21, 2026
• Results First Posted: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)