Clinical trial NCT06556069: Clinical Trial of Peer Support in the ED (PCORI)
Official title: Peer Support Enhanced Behavioral Crisis Response Teams in the Emergency Department
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychomotor Agitation
Behavioral Disorder
Keywords: Agitation
Peer Support
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-08-15
Enrollment: 57870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a stepped wedge, cluster randomized study design that evaluates the impact of the PACT intervention. Our unit of randomization is at the cluster (i.e., ED site) level. A sample of five ED sites will complete the stepped-wedge cluster randomized trial with six time periods (including the baseline), five steps, and each site randomized from control to intervention at each step. The trial will be conducted over three years, with each period duration being six months.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Rate of Restraint Use
timeFrame: Up to 1 day
Secondary outcomes:
measure: Agitation Symptom Level
timeFrame: Up to 1 day
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital Health System
state: Connecticut
Study officials:
affiliation: Yale University
name: Ambrose Wong, MD, MSEd, MHS
role: PRINCIPAL_INVESTIGATOR
References: