Psychomotor AgitationNCT04959279
ED-TREAT (Early Detection and Treatment to Reduce Events With Agitation Tool) Compared to Usual Care
A study testing ED-TREAT in people with Psychomotor Agitation and Behavioral Disorder, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to conduct a a pilot trial that tests the acceptability, fidelity, and feasibility of ED-TREAT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychomotor Agitation, Behavioral Disorder
- What is being tested?
- ED-TREAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult (age≥18) patients presenting to the YNHH ED during the pilot trial period
- deemed to have a mild-moderate or high risk of agitation as determined by ED-TREAT
- do not require physical restraint orders <30 minutes of arrival
- with a score of "4" (quiet and awake; normal level of activity) on the Behavioral Activity Rating Scale
- have comfort with conversational English
- able to provide verbal consent.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: A Pilot Randomized Controlled Trial of ED-TREAT (Early Detection and Treatment to Reduce Events With Agitation Tool) Compared to Usual Care
The purpose of this study is to conduct a a pilot trial that tests the acceptability, fidelity, and feasibility of ED-TREAT.
Read the detailed description
This study will be a pilot RCT that compares ED-TREAT to usual care. The scientific premise of the proposed project is that an innovative EHR-embedded clinical decision support (CDS) tool can overcome the challenges to risk assessment and suggest pre-emptive use of behavioral techniques in the emergency setting. This would help clinicians appropriately invest resources to improve the quality of care for at-risk patients regardless of ultimate medical or psychiatric diagnoses and prevent agitation from occurring.
This pilot trial will (1) test the integrity of the study protocol in preparation for a future full-scale RCT, (2) evaluate randomization protocols, (3) estimate rates of recruitment and retention, (4) assess acceptability and fidelity of the intervention, and (5) determine if the proposed effect size is reasonable.
This registered study is actually the third aim of a larger study where the tool will be developed and assessed using observational data and input from a steering committee in aims 1 and 2 prior to pilot testing.
- Conditions
- Psychomotor Agitation, Behavioral Disorder
- Being tested
- ED-TREAT
- Medical subject headings
- Psychomotor Agitation, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED-TREATOther
Patients will be assessed and treated based on a clinical decision support system.
| Study group | Role | What they receive |
|---|---|---|
| ED-TREAT | Experimental | EHR-embedded clinical decision support (CDS) tool designed to overcome the challenges to risk assessment and suggest pre-emptive use of behavioral techniques in the emergency setting. Receives: Other: ED-TREAT |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of visits adherent to protocol
Proportion of visits in the intervention arm that are adherent to >95% of the observational workflow checklist (primary outcome of fidelity)
Measured: 12 months
Secondary outcomes (1)
System usability scale
Acceptability will be measured using a scale the System Usability Scale. The System Usability Scale is a widely used and effective survey composed of ten statements assessed on a 5-point Likert scale, with inter-item correlations of 0.69-0.75 and a reliability coefficient α of 0.91. The scale provides continuous data from 0-100 with scores >85 as indicative of excellent usability, and will be described using mean and standard deviation. The study will consider ED-TREAT to be acceptable if at least 90% of each clinician group give ratings >85.
Measured: Baseline, 15 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Apr 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Why it stopped: PI is in process of transferring to a new institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychomotor AgitationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 randomization and also recruit a higher proportion of high-risk patients in each arm
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ambrose H. Wong, (203) 737-2489, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959279
- Sponsor's protocol ID
- 2000030906
- Other IDs
- K23MH126366-01A1
- Status last verified
- Mar 2026
- First submitted
- 30 Jun 2021
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong AH, Nath B, Shah D, Kumar A, Brinker M, Faustino IV, Boyce M, Dziura JD, Heckmann R, Yonkers KA, Bernstein SL, Adapa K, Taylor RA, Ovchinnikova P, McCall T, Melnick ER. Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol. BMJ Open. 2024 Feb 19;14(2):e082834. doi: 10.1136/bmjopen-2023-082834.
PubMed 38373857
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of ED-TREAT (Early Detection and Treatment to Reduce Events With Agitation Tool) Compared to Usual Care
- ClinicalTrials.gov ID
- NCT04959279
- Acronym / sponsor ID
- 2000030906
- Conditions
- Psychomotor Agitation, Behavioral Disorder
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PI is in process of transferring to a new institution
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to conduct a a pilot trial that tests the acceptability, fidelity, and feasibility of ED-TREAT.
Detailed description
This study will be a pilot RCT that compares ED-TREAT to usual care. The scientific premise of the proposed project is that an innovative EHR-embedded clinical decision support (CDS) tool can overcome the challenges to risk assessment and suggest pre-emptive use of behavioral techniques in the emergency setting. This would help clinicians appropriately invest resources to improve the quality of care for at-risk patients regardless of ultimate medical or psychiatric diagnoses and prevent agitation from occurring.
This pilot trial will (1) test the integrity of the study protocol in preparation for a future full-scale RCT, (2) evaluate randomization protocols, (3) estimate rates of recruitment and retention, (4) assess acceptability and fidelity of the intervention, and (5) determine if the proposed effect size is reasonable.
This registered study is actually the third aim of a larger study where the tool will be developed and assessed using observational data and input from a steering committee in aims 1 and 2 prior to pilot testing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2:1 randomization and also recruit a higher proportion of high-risk patients in each arm
| Arm | Type | Receives |
|---|---|---|
| ED-TREAT | Experimental | Other: ED-TREATEHR-embedded clinical decision support (CDS) tool designed to overcome the challenges to risk assessment and suggest pre-emptive use of behavioral techniques in the emergency setting. |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult (age≥18) patients presenting to the YNHH ED during the pilot trial period
- deemed to have a mild-moderate or high risk of agitation as determined by ED-TREAT
- do not require physical restraint orders <30 minutes of arrival
- with a score of "4" (quiet and awake; normal level of activity) on the Behavioral Activity Rating Scale
- have comfort with conversational English
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ED-TREATPatients will be assessed and treated based on a clinical decision support system. | Other | ED-TREAT |
Primary outcome
Proportion of visits adherent to protocol
Time frame: 12 months
Proportion of visits in the intervention arm that are adherent to >95% of the observational workflow checklist (primary outcome of fidelity)
1 secondary outcome
System usability scale
Time frame: Baseline, 15 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Derived from this study: PubMed 38373857Wong AH, Nath B, Shah D, Kumar A, Brinker M, Faustino IV, Boyce M, Dziura JD, Heckmann R, Yonkers KA, Bernstein SL, Adapa K, Taylor RA, Ovchinnikova P, McCall T, Melnick ER. Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol. BMJ Open. 2024 Feb 19;14(2):e082834. doi: 10.1136/bmjopen-2023-082834.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ambrose H. Wong, (203) 737-2489 principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ED-TREAT in people with Psychomotor Agitation and Behavioral Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of visits adherent to protocol (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.