Peer Support for Psychomotor Agitation

Overseen By Ambrose Wong, MD, MSEd, MHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Pregnant, Minors, Prisoners, Institutionalized

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a peer support system, the Peer-Support Enhanced Agitation Code Team (PACT), can manage agitation in emergency rooms. The goal is to evaluate how well trained peers assist patients with behavioral needs through empathic listening and guidance during their visit. This approach is compared to the standard care currently provided by hospitals. Participants should speak English, be over 18, and visit a participating emergency department with a behavioral-related issue. As an unphased trial, this study provides a unique opportunity to contribute to innovative care solutions in emergency settings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this peer support intervention is safe for managing agitation?

Research has shown that peer support programs, such as the Peer-Support Enhanced Agitation Code Team (PACT), are generally well-received. Studies have found that peer support in emergency rooms can safely manage agitation. For instance, peer support teams have led to fewer injuries and improved patient experiences. No major reports of negative effects from these programs have emerged, suggesting that PACT is a safe method for handling agitation in emergency settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Peer-Support Enhanced Agitation Code Team (PACT) because it introduces a fresh approach to managing psychomotor agitation. Unlike standard care, which typically relies on medication and restraint, PACT leverages trained peers to deliver trauma-informed care directly in the emergency department. This method focuses on empathic listening and building therapeutic relationships, aiming to address patients' behavioral needs more holistically. By involving peers who can relate and communicate effectively with patients, PACT has the potential to improve patient experience and outcomes in real-time.

What evidence suggests that the Peer-Support Enhanced Agitation Code Team (PACT) is effective for managing psychomotor agitation?

This trial will compare the Peer-Support Enhanced Agitation Code Team (PACT) intervention with standard care. Research has shown that peer support can help manage psychomotor agitation, characterized by increased activity or aggression. Studies comparing peer support teams to regular emergency care have found that these teams calm patients more effectively. They achieve this by listening, building trust, and explaining the treatment process to patients. This approach can reduce the need for stronger measures, such as restraints or medication. Overall, peer support teams offer a compassionate way to handle agitation in emergency situations. ^{1 2 3 4 6}

Who Is on the Research Team?

Ambrose Wong, MD, MSEd, MHS

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This clinical trial is for individuals experiencing psychomotor agitation or behavioral disorders in the emergency department. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

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

Institutionalized individuals

Pregnant women

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline/Pre-implementation

Standard care occurs with no quality improvement programs or interventions related to agitation management

Duration not specified

PACT Implementation

Implementation of the PACT intervention with trained peers working ED shifts alongside the structured code team

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on engagement to follow-up care and decrease in repeat ED visits

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peer-Support Enhanced Agitation Code Team (PACT)

Trial Overview The trial is testing a new approach called Peer-Support Enhanced Agitation Code Team (PACT) designed to manage agitation within the emergency department setting. It aims to evaluate how acceptable, faithful to design, and feasible this peer support intervention is.

How Is the Trial Designed?

Group I: PACT Implementation Experimental Treatment 1 Intervention

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.

Group II: Standard Care Active Control 1 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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

The PeerTECH intervention, a digital peer support program for adults with serious mental illness, was found to be feasible and acceptable, showing significant improvements in self-efficacy and personal empowerment over a 12-week period with 21 participants.

Preliminary evidence suggests that this intervention can enhance self-management skills for both medical and psychiatric conditions, indicating its potential as a valuable tool in supporting recovery for individuals with serious mental illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing a digital peer support self-management intervention for adults with serious mental illness: feasibility, acceptability, and preliminary effectiveness. Fortuna, KL., Myers, AL., Ferron, J., et al.[2023]

A systematic review of 42 studies on psychopharmacological treatments for psychomotor agitation in children and adolescents identified ziprasidone, risperidone, aripiprazole, olanzapine, and valproic acid as the most commonly used medications.

The review highlighted a need for further research to better understand the safety and efficacy of these treatments, as the existing studies had limited observations and varied methodologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Critical Review of the Psychomotor Agitation Treatment in Youth. Tripodi, B., Matarese, I., Carbone, MG.[2023]

In a study involving 292 participants from 31 psychiatric outreach teams, the presence of peer specialists (PS) was associated with a significantly lower risk of hospitalization, with a hazard ratio of 0.53, indicating a protective effect against hospital admissions.

While the presence of PS improved hospitalization rates, there were no significant differences in social functioning or problem behaviors between clients cared for by teams with or without PS after 6 months, suggesting that while PS may help reduce hospitalizations, their impact on overall social functioning needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of hospital admission rates for psychiatric patients cared for by multidisciplinary outreach teams with and without peer specialist: a retrospective cohort study of Japanese Outreach Model Project 2011-2014. Kido, Y., Kawakami, N., Kayama, M.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12161358/

Peer support enhanced behavioural crisis response teams ... The goal of this study is to evaluate if the implementation of a Peer support enhanced Agitation Crisis response Team (PACT) for behavioural ...

2. withpower.com withpower.com/trial/peer-support-for-psychomotor-agitation-1e06c

Peer Support for Psychomotor Agitation · Info for Participants 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 ...

3. pcori.org pcori.org/research-results/2023/comparing-effectiveness-peer-support-enhanced-behavioral-crisis-response-teams-usual-emergency-department-care-agitated-patients

Comparing the Effectiveness of Peer Support Enhanced ... This study compares the effectiveness of a peer support enhanced behavioral crisis response team to usual emergency department care on ...

4. annemergmed.com annemergmed.com/article/S0196-0644(21)01381-0/fulltext

Design and Implementation of an Agitation Code ... Agitation, defined as excessive psychomotor activity leading to violent and aggressive behavior, is becoming more prevalent in the emergency ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40484432/

Peer support enhanced behavioural crisis response teams in ... 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 ...

6. researchgate.net researchgate.net/publication/356709592_Design_and_Implementation_of_an_Agitation_Code_Response_Team_in_the_Emergency_Department

Design and Implementation of an Agitation Code ... The goal of this study is to evaluate if the implementation of a Peer support enhanced Agitation Crisis response Team (PACT) for behavioural ...