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

57870 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

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

Is peer support for psychomotor agitation safe for humans?

The safety of peer support for psychomotor agitation isn't directly addressed in the available research, but related interventions like verbal de-escalation and individualized therapeutic activities have been used to manage agitation safely in various settings. ^{1 2 3 4 5}

How is the Peer-Support Enhanced Agitation Code Team (PACT) treatment different from other treatments for psychomotor agitation?

The Peer-Support Enhanced Agitation Code Team (PACT) treatment is unique because it incorporates peer support, where individuals with similar experiences provide assistance and understanding, which is not typically a component of standard treatments for psychomotor agitation. This approach can enhance the effectiveness of care by offering emotional support and practical advice from someone who has been through similar challenges. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Peer-Support Enhanced Agitation Code Team (PACT)?

Research shows that engaging patients in individualized therapeutic activities can reduce agitation, with 73% of patients experiencing decreased agitation during activities and 64% remaining calmer afterward. Additionally, using a rapid agitation assessment and treatment protocol in psychiatric settings has been shown to reduce restraint events by 44%, suggesting that structured approaches to managing agitation can be effective. ^{1 3 5 11 12}

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

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]

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]

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. United States pubmed.ncbi.nlm.nih.gov

Decreasing patient agitation using individualized therapeutic activities. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

The Utilization of a Rapid Agitation Scale and Treatment Protocol for Patient and Staff Safety in an Inpatient Psychiatric Setting. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Improving the management of acutely agitated patients in the emergency department through implementation of Project BETA (Best Practices in the Evaluation and Treatment of Agitation). [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

1st International Experts' Meeting on Agitation: Conclusions Regarding the Current and Ideal Management Paradigm of Agitation. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A brief agitation rating scale (BARS) for nursing home elderly. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Critical Review of the Psychomotor Agitation Treatment in Youth. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Measuring psychomotor agitation by use of an actimeter: a pilot study. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Predicting Psychiatric Hospitalizations among Elderly Veterans with a History of Mental Health Disease. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Augmenting Ongoing Depression Care With a Mutual Peer Support Intervention Versus Self-Help Materials Alone: A Randomized Trial. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Changes in Perception of Caregiving Experience Following Caregiver Peer Support Within a Mental Health and Addictions Navigation Service. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Assessing a digital peer support self-management intervention for adults with serious mental illness: feasibility, acceptability, and preliminary effectiveness. [2023]

12. England 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. [2019]