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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH126366-01A1 | U.S. NIH Grant/Contract | View source |
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PI is in process of transferring to a new institution
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ED-TREAT | Experimental | 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. |
|
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ED-TREAT | Other | Patients will be assessed and treated based on a clinical decision support system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Ambrose H. Wong, (203) 737-2489 | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38373857 | Derived | Wong AH, Nath B, Shah D, Kumar A, Brinker M, Faustino IV, Boyce M, Dziura JD, Heckmann R, Yonkers KA, Bernstein SL, Adapa K, Taylor RA, Ovchinnikova P, McCall T, Melnick ER. Formative evaluation of an emergency department clinical decision support system for agitation symptoms: a study protocol. BMJ Open. 2024 Feb 19;14(2):e082834. doi: 10.1136/bmjopen-2023-082834. |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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2:1 randomization and also recruit a higher proportion of high-risk patients in each arm
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| Baseline, 15 hours |
| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |