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
The purpose of this study is to conduct a a pilot trial that tests the acceptability, fidelity, and feasibility of ED-TREAT.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Yale New Haven Hospital | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute of Mental Health (NIMH) |
United States,
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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