Clinical Trial of Peer Support in the ED (PCORI)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Pregnant women, minors (<18 years old), prisoners, and institutionalized individuals
Trial design
Design model
Sequential
Treatments tested in this trial
Peer-Support Enhanced Agitation Code Team (PACT)
Other interventionPACT 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.
Treatment groups
57,870 Participants
are divided into 2 treatment groupsGroup A: Standard CareNo intervention 0 interventions
Group B: PACT ImplementationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Restraint Use
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.
Time frame
Up to 1 daySecondary outcomes
1
Agitation Symptom Level
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.
Time frame
Up to 1 daySponsors and contacts
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Yale University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: