Clinical Trial of Peer Support in the ED (PCORI)

NCT06556069 | Not Yet Recruiting DMC

• 2 other identifiers: 2000038473BPS-2022C3-30381
• Study Type: interventional
• Target: 57,870
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychomotor Agitation; Behavioral Disorder

Keywords

Agitation; Peer Support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Agitation Symptom Level

  Up to 1 day

Study Arms (2)

Standard Care

NO INTERVENTION

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.

PACT Implementation

EXPERIMENTAL

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)

Interventions

Peer-Support Enhanced Agitation Code Team (PACT) OTHER

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.

PACT Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Yale New Haven Hospital Health System

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• 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.

  PMID: 40484432 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation; Mental Disorders

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Ambrose Wong, MD, MSEd, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ambrose Wong, MD, MSEd, MHS

CONTACT

(203) 737-2489; ambrose.wong@yale.edu

Bidisha Nath, MBBS, MPH

CONTACT

(617) 413-8571; bidisha.nath@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: We will not utilize masking.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)