Clinical Trial of Peer Support in the ED (PCORI)

Peer Support Enhanced Behavioral Crisis Response Teams in the Emergency Department

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psychomotor Agitation; Behavioral Disorder
• Intervention / Treatment: Other: Peer-Support Enhanced Agitation Code Team (PACT)

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
• Enrollment (Estimated): 57870
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ambrose Wong, MD, MSEd, MHS; Phone Number: (203) 737-2489; Email: ambrose.wong@yale.edu
• Study Contact Backup: Name: Bidisha Nath, MBBS, MPH; Phone Number: (617) 413-8571; Email: bidisha.nath@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital Health System
      • Contact: Ambrose H. Wong, MD, MSEd, MHS; Phone Number: (203) 737-2489; Email: ambrose.wong@yale.edu
      • Principal Investigator: Ambrose H. Wong, MD, MSEd, MHS
      • Contact: Bidisha Nath, MBBS, MPH; Phone Number: (617) 413-8571; Email: bidisha.nath@yale.edu
      • Sub-Investigator: Bidisha Nath, MBBS, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; Standard of care will occur during the baseline/pre-implementation phase and no quality improvement programs or interventions related to agitation management will occur during this time period.
Experimental: PACT Implementation; 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.	Other: Peer-Support Enhanced Agitation Code Team (PACT); 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. The PACT intervention includes a peer support service component to deliver patient-centered, trauma-informed, culturally sensitive care to patients presenting with behavioral complaints in the ED and experiencing distress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Restraint Use	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.	Up to 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agitation Symptom Level	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.	Up to 1 day

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Ambrose Wong, MD, MSEd, MHS, Yale University

Publications and helpful links

General Publications

• Nath B, Desai R, Cook JM, Dziura JD, Davis-Plourde K, Youins R, Guy K, Pavlo AJ, Smith PE, Smith PD, Kangas K, Heckmann R, Hart L, Powsner S, Sevilla M, Evans M, Kumar A, Faustino IV, Hu Y, Bellamy C, Wong AH. Peer support enhanced behavioural crisis response teams in the emergency department: protocol for a stepped-wedge cluster-randomised controlled trial. BMJ Open. 2025 Jun 8;15(6):e103775. doi: 10.1136/bmjopen-2025-103775.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Agitation; Peer Support
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Nervous System Diseases; Behavioral Symptoms; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Mental Disorders; Psychomotor Agitation
• Other Study ID Numbers: 2000038473; BPS-2022C3-30381 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No