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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 Summary

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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04959279
Study type Interventional
Source Yale University
Contact Ambrose H. Wong, MD, MSEd, MHS
Phone (203) 737-2489
Email ambrose.wong@yale.edu
Status Not yet recruiting
Phase N/A
Start date December 1, 2024
Completion date June 1, 2026
View Details
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