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NCT06556069 | NOT YET RECRUITING | Psychomotor Agitation


Clinical Trial of Peer Support in the ED (PCORI)
Sponsor:

Yale University

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.

Condition or disease

Psychomotor Agitation

Behavioral Disorder

Intervention/treatment

Peer-Support Enhanced Agitation Code Team (PACT)

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 57870 participants
Masking : NONE
Masking Description : We will not utilize masking.
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Peer Support Enhanced Behavioral Crisis Response Teams in the Emergency Department
Actual Study Start Date : 2025-12-01
Estimated Primary Completion Date : 2028-12-01
Estimated Study Completion Date : 2029-05-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

Clinical Trial of Peer Support in the ED (PCORI)

Location Details

NCT06556069


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Locations


Not yet recruiting

United States, Connecticut

Yale New Haven Hospital Health System

New Haven, Connecticut, United States, 06510

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