Behavioral Disorder, Psychomotor Agitation
Conditions
Keywords
Agitation, Peer Support
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.
Detailed 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.
Interventions
OTHERPeer-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.
Sponsors
Yale University
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
We will not utilize masking.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Restraint Use | Up to 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agitation Symptom Level | Up to 1 day | Levels and symptoms of agitation during an ED visit will be measured by the Brøset Violence Checklist (BVC), a validated risk assessment tool used to predict violent behavior within a 24-hour period based on presence or absence of patient behaviors and characteristics. Minimum score = 0 and maximum score = 6. Interpretation as follows: 0 score indicates a small/low risk of violence, a score of 1-2 indicates moderate risk of violence, and a score greater than 2 indicates high risk of violence and a need to develop a plan to manage patient's violence. |
Countries
United States
Contacts
CONTACTAmbrose Wong, MD, MSEd, MHS
CONTACTBidisha Nath, MBBS, MPH
PRINCIPAL_INVESTIGATORAmbrose Wong, MD, MSEd, MHS
Yale University
Outcome results
None listed