TEaM Intervention for Traumatic Brain Injury

(TEaM Trial)

Recruiting at 2 trial locations

Overseen By Alex Hall, DHSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Non-English, Severe developmental, Severe psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate a multi-disciplinary, multi-setting intervention with the goal of improving outcomes for children who have experienced a mild traumatic brain injury (mTBI). The project aims to improve and support mTBI diagnosis and management, and improve critical decision making by clinicians during their interaction with the injured child, their family, and their school.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the TEaM Intervention treatment for Traumatic Brain Injury?

Research shows that a multidisciplinary approach, like the TEaM Intervention, can improve patient satisfaction and retention in TBI clinical trials. Additionally, simulation-based training for staff enhances their skills and confidence in managing TBI, which may lead to better patient outcomes. ^{1 2 3 4 5}

How is the TEaM Intervention treatment for traumatic brain injury different from other treatments?

The TEaM Intervention for traumatic brain injury is unique because it involves a multi-disciplinary care team that provides individualized, evidence-based treatment programs, focusing on team cooperation and memory training, which is not typically emphasized in standard treatments. ^{1 5 6 7 8}

Research Team

David Wright, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for children who have had a mild traumatic brain injury (mTBI). It's also for healthcare providers within the CHOA System, specifically those working in emergency departments, urgent care, or as primary care physicians.

Inclusion Criteria

PROVIDER INCLUSION CRITERIA

Primary practice in either ED, UC, and/or PCP

Actively practicing physician or APP in the CHOA System

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Multi-disciplinary, multi-setting intervention to improve mTBI diagnosis and management, including provider education and information technology support

32 months

Follow-up

Participants are monitored for safety and effectiveness after intervention, focusing on school performance and symptom recovery

3 months

Multiple visits as needed for follow-up assessments

Treatment Details

Interventions

• Standard of Care
• TEaM Intervention

Trial Overview The TEaM Intervention is being tested against the standard of care to see if it improves outcomes after a child has suffered an mTBI. The study focuses on enhancing diagnosis and management practices by clinicians.

Participant Groups

Group I: TEaM Intervention Group Experimental Treatment 1 Intervention

Dedicated Provider Education plus Information Technology Support. The IT support includes addition of an eMR concussion screening, followed by an alert to the provider, followed by a structured assessment / evaluation template.

Group II: Control Group Active Control 1 Intervention

Standard medical protocol for the management of mTBI in children. This group will not receive interventional Provider Training on the TEaM concussion evaluation examination and utilization of the eMR template.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Children's Healthcare of Atlanta

Collaborator

Trials

172

Recruited

108,000+

Findings from Research

In a study involving 90 participants with chronic traumatic brain injury (TBI), the TEAM-TBI program demonstrated high satisfaction rates, with 100% of participants rating their experience positively during the initial evaluation.

The multi-disciplinary care approach, particularly the Clinical Coach component, was highly rated and contributed to strong participant motivation and retention throughout the six-month intervention phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Multi-Disciplinary Care and Clinical Coach Coordinators on Participant Satisfaction and Retention in TBI Clinical Trials: A TEAM-TBI Study. Mesley, MS., Edelman, K., Sharpless, J., et al.[2019]

Implementing a regular simulation-based team training program for staff in general intensive care units significantly improved their skills, knowledge, and confidence in treating traumatic brain injury (TBI) in polytrauma patients.

The quality improvement project not only showed high staff engagement but also has the potential for cost savings and aims to enhance clinical outcomes for TBI patients in settings lacking dedicated neurocritical care facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation-based training improves ITU staff knowledge in the management of head injuries. Smith, M., Jankowski, S.[2020]

Implementing a structured team briefing tool before the arrival of multiple trauma patients significantly improved perceived interprofessional collaboration and communication among trauma team members, as shown by a study involving 46 participants over 3 months.

Statistically significant improvements were observed in 16 items of the assessment scales, indicating that better teamwork can enhance the safety and effectiveness of trauma care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Structured Briefing Prior to Patient Arrival on Interprofessional Communication and Collaboration in the Trauma Team. Iattoni, M., Ormazabal, M., Luvini, G., et al.[2023]

An integrated multidisciplinary approach is essential for providing effective care to patients with severe traumatic brain injuries (TBI), emphasizing the need for continuous evaluation and adaptation of clinical practices based on the latest evidence.

Standardizing interventions into protocols enhances team communication and coordination, while measuring treatment outcomes is crucial for assessing the effectiveness of care and guiding future practice changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keeping the brain in the zone. Applying the severe head injury guidelines to practice. Bader, MK., Palmer, S.[2007]

The intervention aimed at improving the alliance between the interdisciplinary team and clients with traumatic brain injury resulted in the treatment group showing higher functional status at discharge compared to the control group, indicating its potential efficacy.

A stronger team alliance was linked to better outcomes, including program completion, return to productivity, improved client relationships, reduced family discord, and fewer depressive symptoms, suggesting that enhancing team dynamics can positively impact recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an interdisciplinary team intervention to improve therapeutic alliance in post-acute brain injury rehabilitation. Evans, CC., Sherer, M., Nakase-Richardson, R., et al.[2019]

Implementing a combined team development and memory training program in a subacute TBI rehabilitation unit improved team members' perceptions of cooperation, indicating enhanced teamwork.

The efficacy of the memory training itself showed variable results, suggesting that while team dynamics improved, the specific cognitive training may need further refinement to achieve consistent outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team development and memory training in traumatic brain injury rehabilitation: two birds with one stone. Finset, A., Krogstad, JM., Hansen, H., et al.[2019]

The TBI Team model, implemented in states like Iowa, Kansas, and Oregon, provides systematic support to educators working with students who have Traumatic Brain Injury (TBI) through trained peer consultants, enhancing instructional strategies and resources.

Evaluation data indicates that this model is both cost-effective and efficient in improving the support teachers receive, ultimately aiming to better meet the unique needs of students with TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving educational services for students with TBI through statewide consulting teams. Glang, A., Tyler, J., Pearson, S., et al.[2022]

The study revealed that the structure and composition of neurological rehabilitation teams varied significantly, with inconsistencies in the adoption of interdisciplinary teamwork and patient involvement across different teams.

Therapists recognized the potential benefits of teamwork in rehabilitation, but the actual implementation of team processes was complex and diverse, indicating a need for more standardized approaches in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapists' experiences and perceptions of teamwork in neurological rehabilitation: reasoning behind the team approach, structure and composition of the team and teamworking processes. Suddick, KM., De Souza, L.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Impact of Multi-Disciplinary Care and Clinical Coach Coordinators on Participant Satisfaction and Retention in TBI Clinical Trials: A TEAM-TBI Study. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Simulation-based training improves ITU staff knowledge in the management of head injuries. [2020]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Effect of Structured Briefing Prior to Patient Arrival on Interprofessional Communication and Collaboration in the Trauma Team. [2023]

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

Keeping the brain in the zone. Applying the severe head injury guidelines to practice. [2007]

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

Evaluation of an interdisciplinary team intervention to improve therapeutic alliance in post-acute brain injury rehabilitation. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Team development and memory training in traumatic brain injury rehabilitation: two birds with one stone. [2019]

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

Improving educational services for students with TBI through statewide consulting teams. [2022]

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

Therapists' experiences and perceptions of teamwork in neurological rehabilitation: reasoning behind the team approach, structure and composition of the team and teamworking processes. [2019]