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Clinical Trials/NCT06556069
NCT06556069
Not Yet Recruiting
N/A

Peer Support Enhanced Behavioral Crisis Response Teams in the Emergency Department

Yale University1 site in 1 country57,870 target enrollmentDecember 1, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychomotor Agitation
Sponsor
Yale University
Enrollment
57870
Locations
1
Primary Endpoint
Rate of Restraint Use
Status
Not Yet Recruiting
Last Updated
10 months ago

Overview

Brief Summary

The purpose of this study is to conduct a clinical trial that tests the acceptability, fidelity, and feasibility of a peer support modified intervention for agitation management within the emergency department.

Detailed Description

The purpose of this study is to address the increasing burden of behavioral crises and agitation in the Emergency Department (ED). There are multiple significant gaps in patient centered care for agitation management and use of restraints in the context of behavioral crises, leading to increased patient risks and reduced workplace safety. Through expanding our previous Agitation Code Team (ACT) protocol with the addition of peer support workers, we plan to develop a peer-support enhanced agitation code team (PACT). The PACT will address systems challenges experienced by staff, safety threats to ED patients with mental illness and substance abuse disorders and reduce known structural biases in marginalized patient populations during restraint/sedation decision making. Additionally, peer support workers delivery of trauma informed care is the key mechanism for mitigating bias in agitation management. This study will build on our team's extensive experience in using a patient-centered approach for investigating best practices in management of agitation in the ED. Thus, we propose a patient centered, trauma informed, structured team-based care delivery approach through the use of a multi-level, multi-component peer-support enhanced agitation code team (PACT) intervention. PACT will address systems challenges experienced by staff, safety threats to ED patients with mental illness and substance use disorders, and known structural biases against marginalized individuals during decisions in use of restraints for behavioral crises in the ED. We hypothesize that the PACT intervention will improve patient outcomes related to behavioral crisis (i.e., reduction in use of restraints, engagement to follow-up care, decrease in repeat ED visits) and improve patient experience of behavioral acute care in the ED for patients presenting with behavioral health chief complaints, especially those from racial/ethnic minority groups and historically marginalized populations compared to usual care.

Registry
clinicaltrials.gov
Start Date
December 1, 2025
End Date
May 1, 2029
Last Updated
10 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older
  • English-speaking
  • Arrives to one of the Yale-New Haven Health emergency departments (Yale-New Haven \[York Street \& St. Raphael's\], Greenwich, Bridgeport, Lawrence \& Memorial, and Westerly campuses)
  • Presents with a behavioral-related chief complaint (inclusive of neurocognitive, substance use/intoxication, mental health and other behavioral related presentations) as well as additional individuals at risk of developing agitation defined via a score of \>2 on the Brøset Violence Checklist

Exclusion Criteria

  • Pregnant women, minors (\<18 years old), prisoners, and institutionalized individuals

Outcomes

Primary Outcomes

Rate of Restraint Use

Time Frame: Up to 1 day

Our primary outcome will be rates of Restraint Use, which will be the percent of patients with a behavioral health chief complaint or at risk for agitation who receive either a physical restraint or chemical restraint (defined as intramuscular administration of a sedative) order during an ED visit, measured as a rate per 1,000 ED visits.

Secondary Outcomes

  • Agitation Symptom Level(Up to 1 day)

Study Sites (1)

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