Psychomotor AgitationNCT06556069
Clinical Trial of Peer Support in the ED (PCORI)
A study testing Peer-Support Enhanced Agitation Code Team (PACT) in people with Psychomotor Agitation and Behavioral Disorder, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychomotor Agitation, Behavioral Disorder
- What is being tested?
- Peer-Support Enhanced Agitation Code Team (PACT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57,870 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 May 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant women, minors (<18 years old), prisoners, and institutionalized individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale New Haven Hospital Health System
New Haven, Connecticut, 06510
Ambrose H. Wong, MD, MSEd, MHS, (203) 737-2489, ambrose.wong@yale.edu
Bidisha Nath, MBBS, MPH, (617) 413-8571, bidisha.nath@yale.edu
About this study
Official title: Peer Support Enhanced Behavioral Crisis Response Teams in the Emergency Department
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.
Read the 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.
- Conditions
- Psychomotor Agitation, Behavioral Disorder
- Being tested
- Peer-Support Enhanced Agitation Code Team (PACT)
- Keywords
- Agitation, Peer Support
- Medical subject headings
- Psychomotor Agitation, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Support Enhanced Agitation Code Team (PACT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | 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 | 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. Receives: Other: Peer-Support Enhanced Agitation Code Team (PACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 day
Secondary 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.
Measured: Up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychomotor AgitationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 57,870 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Ambrose Wong, MD, MSEd, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556069
- Sponsor's protocol ID
- 2000038473
- Other IDs
- BPS-2022C3-30381
- Status last verified
- May 2026
- First submitted
- 13 Aug 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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: 10.1136/bmjopen-2025-103775.
PubMed 40484432