Clinical Trial of Peer Support in the ED (PCORI)

Not Applicable

Not yet recruiting

• Conditions: Behavioral Disorder; Psychomotor Agitation
• Interventions: Other: Peer-Support Enhanced Agitation Code Team (PACT)

• Registration Number: NCT06556069
• Lead 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.

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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15
• Study Start: 2025-12-01
• Primary Completion: 2028-12-01
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 57870

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PACT Implementation	Peer-Support Enhanced Agitation Code Team (PACT)	Implementation of the PACT intervention. After a site is randomized to implement PACT, trained peers will be assigned to work ED shifts alongside the structured code team. ED patients with behavioral needs will receive peer-led TIC, including empathic listening, therapeutic relationship building, understanding of patient needs and goals for the visit, and informing of patients and family about the evaluation process in real-time.

Primary Outcome Measures

Name	Time	Method
Rate of Restraint Use	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 Outcome Measures

Name	Time	Method
Agitation Symptom Level	Up to 1 day	Levels and symptoms of agitation during an ED visit will be measured by the Brøset Violence Checklist (BVC), a validated risk assessment tool used to predict violent behavior within a 24-hour period based on presence or absence of patient behaviors and characteristics.; Minimum score = 0 and maximum score = 6. Interpretation as follows: 0 score indicates a small/low risk of violence, a score of 1-2 indicates moderate risk of violence, and a score greater than 2 indicates high risk of violence and a need to develop a plan to manage patient's violence.

Trial Locations

Locations (1)

Yale New Haven Hospital Health System; 🇺🇸 New Haven, Connecticut, United States