Nath Bidisha, Desai Riddhi, Cook Joan M, Dziura James D, Davis-Plourde Kendra, Youins Richard, Guy Kimberly, Pavlo Anthony J, Smith Pastor Evelyn, Smith Pastor Dana, Kangas Karen, Heckmann Rebekah, Hart Lou, Powsner Seth, Sevilla Mark, Evans Megan, Kumar Anusha, Faustino Isaac V, Hu Yue, Bellamy Chyrell, Wong Ambrose H
Department of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.
BMJ Open. 2025 Jun 8;15(6):e103775. doi: 10.1136/bmjopen-2025-103775.
Despite expert recommendations to prioritise non-invasive and patient-centred approaches for behavioural crisis management, physical restraints are commonly used in the emergency department (ED). Patients describe the restraint process as coercive and dehumanising. The use of peer support workers, who are individuals with lived experience of mental illness and behavioural conditions, has shown positive patient outcomes when assisting individuals experiencing behavioural crises. However, there is limited evidence of the implementation of such an approach in the ED setting. The goal of this study is to evaluate if the implementation of a Peer support enhanced Agitation Crisis response Team (PACT) for behavioural crisis management in the ED is more effective than usual care to reduce restraint use and improve outcomes among patients presenting to the ED with behavioural crises.
We will first conduct a stakeholder-informed needs assessment to codesign the protocol and then train staff and peers in PACT intervention readiness. Next, a stepped-wedge, cluster-randomised controlled trial will be conducted over 3 years at five ED sites across a healthcare system in the Northeast USA. The PACT intervention will integrate peer delivery of trauma-informed care within a structured, interprofessional, team-based response protocol for behavioural crisis management. The primary outcome is the rate of physical restraint and/or sedation use. The secondary outcome is the level of patient agitation during the ED visit. Analyses of primary and secondary outcomes will be conducted using generalised linear mixed models.
This protocol has been approved by the Yale University Human Investigation Committee (protocol number 2000037554). The study is deemed minimal risk and has been granted a waiver of consent for trial participants. However, verbal consent will be obtained for a subset of patients receiving follow-up data collection. Results will be disseminated through publications in open-access, peer-reviewed journals, via scientific presentations, or through direct mail notifications.
Clinicaltrials.gov: NCT06556069.
尽管专家建议将非侵入性和以患者为中心的方法作为行为危机管理的优先选择，但急诊科（ED）仍普遍使用身体约束措施。患者将约束过程描述为强制性和不人道的。同伴支持工作者是有精神疾病和行为状况生活经历的个体，在协助经历行为危机的个体时，已显示出对患者有积极的效果。然而，在急诊科环境中实施这种方法的证据有限。本研究的目的是评估在急诊科实施同伴支持增强型躁动危机应对团队（PACT）进行行为危机管理是否比常规护理更有效，以减少约束措施的使用并改善急诊科出现行为危机的患者的结局。
我们将首先进行利益相关者参与的需求评估，以共同设计方案，然后对工作人员和同伴进行PACT干预准备培训。接下来，将在美国东北部一个医疗系统的五个急诊科地点进行为期3年的阶梯式楔形整群随机对照试验。PACT干预将把同伴提供的创伤知情护理纳入行为危机管理的结构化、跨专业、基于团队的应对方案中。主要结局是身体约束和/或使用镇静剂的比率。次要结局是急诊科就诊期间患者的躁动程度。将使用广义线性混合模型对主要和次要结局进行分析。
本方案已获得耶鲁大学人类研究委员会批准（方案编号2000037554）。该研究被认为风险极小，并已获得试验参与者的同意豁免。然而，对于接受随访数据收集的一部分患者，将获得口头同意。结果将通过在开放获取、同行评审期刊上发表、科学报告或直接邮寄通知的方式进行传播。
Clinicaltrials.gov：NCT06556069。
