New ER tool aims to tame agitation without restraints
NCT ID NCT04959279
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests a tool called ED-TREAT that helps emergency room staff spot and treat agitation early. The goal is to see if the tool is easy to use and can reduce the need for physical restraints. The study involves 26 adults at Yale New Haven Hospital, but enrollment is currently on hold.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ED-TREAT clinical decision support system
- What this could lead to
- If successful, this tool could help emergency departments manage agitated patients more calmly and reduce the need for physical restraints.
- What could go wrong
- This is a very small pilot study (26 people) testing only feasibility, not effectiveness. The trial is currently suspended, so results may be delayed or inconclusive.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
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