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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
First received
Last updated
Start date December 1, 2024
Est. completion date September 2025

Study information

Verified date June 2024
Source Yale University
Contact Ambrose H. Wong, MD, MSEd, MHS
Phone (203) 737-2489
Email ambrose.wong@yale.edu
Is FDA regulated No
Health authority
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 September 2025
Est. primary completion date September 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)

Study Design


Related Conditions & MeSH terms


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
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