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Search / Trial NCT04959279

ED-TREAT (Early Detection and Treatment to Reduce Events With Agitation Tool) Compared to Usual Care

Launched by YALE UNIVERSITY · Jun 30, 2021

Trial Information

Current as of July 27, 2025

Not yet recruiting

Keywords

ClinConnect Summary

The ED-TREAT trial is designed to test a new approach called ED-TREAT, which aims to help detect and manage agitation in patients who visit the emergency department. This study will compare the ED-TREAT method to usual care to see how well it works and how acceptable it is for patients. The researchers want to find out if this new tool can help prevent worsening agitation and improve patient outcomes.

To participate in this trial, you must be an adult (18 years or older) who comes to the emergency department at Yale New Haven Hospital during the study period. You should have a mild to moderate risk of agitation, but you should not need physical restraints within 30 minutes of arriving. Additionally, you need to be able to speak and understand conversational English and give your verbal consent to join the study. If you qualify, you can expect to receive care that focuses on your comfort and safety while helping the medical team learn more about managing agitation in emergency situations. Please note that this trial is not yet recruiting participants.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. adult (age≥18) patients presenting to the YNHH ED during the pilot trial period
  • 2. deemed to have a mild-moderate or high risk of agitation as determined by ED-TREAT
  • 3. do not require physical restraint orders \<30 minutes of arrival
  • 4. with a score of "4" (quiet and awake; normal level of activity) on the Behavioral Activity Rating Scale
  • 5. have comfort with conversational English
  • 6. able to provide verbal consent.
  • Exclusion Criteria:
  • 1. Presence of a restraint order \<30 minutes of arrival and presence of a non-violent physical restraint order where indications are not due to agitation (e.g., for protecting intubation or life-preserving equipment)

About Yale University

Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.

Locations

New Haven, Connecticut, United States

Patients applied

0 patients applied

Trial Officials

Ambrose H. Wong, (203) 737-2489

Principal Investigator

Yale University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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