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ED Delirium Screening for Delirium (ED-DDP Trial)

N/A

Waitlist Available

Led By Liron Sinvani, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 9 months

Awards & highlights

ED-DDP Trial Summary

This trial will study a program to help detect delirium in older adults presenting to Emergency Departments and evaluate whether it improves screening and management.

Who is the study for?

This trial is for older adults who experience delirium when they come to the emergency department (ED). Participants must be at a study site during specific periods and survive until they're discharged or admitted to the hospital. They can't join if they visit during times when the ED Delirium Detection Program is being put into place.Check my eligibility

What is being tested?

The trial tests an Emergency Department Delirium Screening and Detection Program (ED-DDP) with two main goals: first, to see how well it works in identifying delirium in patients across different EDs; second, to evaluate how well nurses and staff adopt this program using interviews, observations, and chart reviews.See study design

What are the potential side effects?

Since this trial involves a screening and detection training program rather than medication or medical procedures, traditional side effects are not applicable. However, there may be indirect impacts on patient care based on how effectively the program is implemented.

ED-DDP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of positive delirium screens among those with delirium

Secondary outcome measures

Proportion of eligible patients who receive delirium screening

Proportion of eligible patients who receive physical and chemical restraints for behavioral symptoms

Proportion of eligible patients who receive safety precautions

ED-DDP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention PeriodExperimental Treatment1 Intervention

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.

Group II: Control PeriodActive Control1 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.

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Who is running the clinical trial?

Northwell HealthLead Sponsor

458 Previous Clinical Trials

467,933 Total Patients Enrolled

1 Trials studying Delirium

18 Patients Enrolled for Delirium

National Institute on Aging (NIA)NIH

1,669 Previous Clinical Trials

28,002,114 Total Patients Enrolled

35 Trials studying Delirium

35,629 Patients Enrolled for Delirium

Liron Sinvani, MDPrincipal InvestigatorNorthwell Health

3 Previous Clinical Trials

230 Total Patients Enrolled

1 Trials studying Delirium

18 Patients Enrolled for Delirium

Media Library

Intervention Period Clinical Trial Eligibility Overview. Trial Name: NCT05638945 — N/A

Delirium Research Study Groups: Intervention Period, Control Period

Delirium Clinical Trial 2023: Intervention Period Highlights & Side Effects. Trial Name: NCT05638945 — N/A

Intervention Period 2023 Treatment Timeline for Medical Study. Trial Name: NCT05638945 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial accepting enrollees at the present moment?

"Contrary to expectations, the data hosted on clinicaltrials.gov does not suggest that this trial is currently seeking patients. The study was first posted on November 28th 2022 and has been inactive since March 3rd 2023; however, there are 338 other trials actively enrolling participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Determining the Preliminary Efficacy of the Emergency Department Delirium Screening and Detection Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05638945.