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

Not Applicable

Not yet recruiting

• Conditions: Psychomotor Agitation; Behavioral Disorder
• Interventions: Other: ED-TREAT

• Registration Number: NCT04959279
• Lead Sponsor: Yale University

Brief Summary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Study Start: 2025-02-01
• Primary Completion: 2025-09-15
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ED-TREAT	ED-TREAT	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.

Primary Outcome Measures

Name	Time	Method
Proportion of visits adherent to protocol	12 months	Proportion of visits in the intervention arm that are adherent to \>95% of the observational workflow checklist (primary outcome of fidelity)

Secondary Outcome Measures

Name	Time	Method
System usability scale	Baseline, 15 hours	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.

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States