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

NCT04959279 | Suspended

• 2 other identifiers: 2000030906K23MH126366-01A1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct a a pilot trial that tests the acceptability, fidelity, and feasibility of ED-TREAT.

Conditions

Psychomotor Agitation; Behavioral Disorder

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Secondary Outcomes (1)

• System usability scale

  Baseline, 15 hours

Study Arms (2)

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.

Other: ED-TREAT

Usual Care

NO INTERVENTION

Interventions

ED-TREAT OTHER

Patients will be assessed and treated based on a clinical decision support system.

ED-TREAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• 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.

  PMID: 38373857 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation; Mental Disorders

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Ambrose H. Wong, (203) 737-2489

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2:1 randomization and also recruit a higher proportion of high-risk patients in each arm

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 13, 2021
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)