Clinical trial NCT04959279: ED-TREAT (Early Detection and Treatment to Reduce Events With Agitation Tool) Compared to Usual Care
Official title: A Pilot Randomized Controlled Trial of ED-TREAT (Early Detection and Treatment to Reduce Events With Agitation Tool) Compared to Usual Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychomotor Agitation
Behavioral Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-07-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 randomization and also recruit a higher proportion of high-risk patients in each arm
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of visits adherent to protocol
timeFrame: 12 months
Secondary outcomes:
measure: System usability scale
timeFrame: Baseline, 15 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Ambrose H. Wong, (203) 737-2489
role: PRINCIPAL_INVESTIGATOR
References: