Clinical Trial of Peer Support in the ED (PCORI)

Yale University

Status: Begins enrollment in 11 months

Conditions: Psychomotor Agitation; Behavioral Disorder

Treatments: Other: Peer-Support Enhanced Agitation Code Team (PACT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06556069

2000038473

BPS-2022C3-30381 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57,870 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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57,870 participants in 2 patient groups

Standard Care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Peer-Support Enhanced Agitation Code Team (PACT)