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

Psychomotor Agitation Clinical Trial

Official title:

A Pilot Randomized Controlled Trial of ED-TREAT (Early Detection and Treatment to Reduce Events With Agitation Tool) Compared to Usual Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04959279
• Other study ID #: 2000030906
• Secondary ID: K23MH126366-01A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: September 2023
• Source: Yale University
• Contact: Ambrose H. Wong, MD, MSEd, MHS
• Phone: (203) 737-2489
• Email: ambrose.wong[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: June 1, 2026
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Behavioral Disorder
• Psychomotor Agitation

Intervention

Other:
• ED-TREAT
Patients will be assessed and treated based on a clinical decision support system.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 a 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.	Baseline, 15 hours