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

Yale University26 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Psychomotor Agitation Behavioral Disorder

Interventions

ED-TREATOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Yale New Haven Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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)

Time frame: 12 months

Secondary Outcomes

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.

Time frame: Baseline, 15 hours

Data from ClinicalTrials.gov

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