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

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Yale University

Status

Begins enrollment in 2 months

Conditions

Psychomotor Agitation
Behavioral Disorder

Treatments

Other: ED-TREAT

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04959279
2000030906
K23MH126366-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

26 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

ED-TREAT
Experimental group
Description:
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.
Treatment:
Other: ED-TREAT
Usual Care
No Intervention group

Trial contacts and locations

1

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Central trial contact

Jessica Ray, PhD; Ambrose H. Wong, MD, MSEd, MHS

Data sourced from clinicaltrials.gov

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