Clinical Trial of Peer Support in the ED (PCORI)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06556069
Status
Not Yet Recruiting

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Conditions

  • Behavioral Disorder
  • Psychomotor Agitation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Dec 1, 2028
Completion
May 1, 2029

Study Design

Enrollment
57,870 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.

Primary Outcome Measure

Rate of Restraint Use [ Time Frame: Up to 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven Hospital Health SystemNew HavenConnecticut06510
Ambrose H. Wong, MD, MSEd, MHS
[email protected]
(203) 737-2489
Bidisha Nath, MBBS, MPH
[email protected]
(617) 413-8571
Ambrose H. Wong, MD, MSEd, MHS (PRINCIPAL_INVESTIGATOR)
Bidisha Nath, MBBS, MPH (SUB_INVESTIGATOR)

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