Clinical Trial of Peer Support in the ED (PCORI)

Официальное название

Peer Support Enhanced Behavioral Crisis Response Teams in the Emergency Department

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Rate of Restraint Use [Срок оценки: Up to 1 day]

Вторичные конечные точки (1)

• Agitation Symptom Level [Срок оценки: Up to 1 day]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Yale New Haven Hospital Health System — New Haven

Публикации

• 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 PMID 40484432

Идентификаторы

NCT: NCT06556069 · 2000038473 · BPS-2022C3-30381

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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