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Determining the Preliminary Efficacy of the Emergency Department Delirium Screening and Detection Program (ED-DDP)

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Northwell Health

Status

Completed

Conditions

Delirium

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05638945
22-0681-350CD
R21AG075230 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Every three months, with the exception of when a site is in their implementation period, trained study staff members will conduct retrospective in-depth chart reviews on 250 randomly selected eligible patient visits per ED site. These chart reviews will assess presence of delirium as well as any corresponding delirium documentation, including the brief confusion assessment method (bCAM) and delirium mitigation and management strategies employed during the patient's ED visit. Charts will be pulled based on dates the participating site is within their control or intervention period (no chart review will take place during program implementation). A total of N=1,000 patients per ED will be reviewed. Two delirium experts will perform chart checks and adjudicate any uncertain cases.

Enrollment

3,000 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

3,000 participants in 2 patient groups

Control Period
No Intervention group
Description:
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 group
Description:
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.
Treatment:
Behavioral: ED Delirium Screening and Detection Program (ED-DDP)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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