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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve the diagnosis and management of children with mild traumatic brain injury (mTBI). It tests the TEaM Intervention, a program that educates healthcare providers and uses technology to aid decision-making. Participants will receive either this new approach or standard care to determine which is more effective. Children who experienced a mild head injury and saw a doctor within three days may qualify. The focus is on those who returned home after their initial medical visit. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance future patient care.

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 prior data suggests that the TEaM Intervention is safe for children with mild traumatic brain injury?

Research has shown that early team-based neuro-rehabilitation, like the TEaM Intervention, is generally well-received by patients with mild traumatic brain injuries (mTBI). In one study of mTBI patients, many experienced symptoms three months after their injury. However, these symptoms did not significantly differ one year later, indicating recovery over time.

The TEaM Intervention includes training for healthcare providers and IT support, such as alerts in electronic medical records. This approach focuses on training and tech support rather than new medications, which suggests it is safe. Similar methods have reported no serious side effects. Overall, the treatment should be safe and manageable for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TEaM Intervention for traumatic brain injury (TBI) because it integrates technology with healthcare practices to enhance concussion management. Unlike the standard care, which often relies on basic medical assessments, the TEaM approach includes a specialized electronic medical record (eMR) system designed to alert providers and guide them through a structured evaluation process. This method aims to streamline diagnosis and improve the accuracy of assessments, potentially leading to better outcomes for patients with mild traumatic brain injuries, especially children. By providing targeted provider education alongside this tech support, the TEaM Intervention could set a new standard in managing concussions more efficiently and effectively.

What evidence suggests that the TEaM Intervention could be effective for improving outcomes in children with mild traumatic brain injury?

Research shows that team-based rehabilitation methods, such as the TEaM Intervention, can enhance recovery for people with traumatic brain injuries (TBI). In this trial, participants in the TEaM Intervention Group will receive dedicated provider education and information technology support, including an eMR concussion screening and structured assessment template. In a study with 90 participants, those with long-term TBI who participated in the TEaM program reported high satisfaction. These methods focus on assisting with everyday tasks and social interactions, which can be challenging after a brain injury. Additionally, a thorough review supports that these approaches can improve daily living and social participation for people with TBI. This suggests that the TEaM Intervention might also effectively manage mild traumatic brain injury in children. ^{5 6 7 8 9}

Who Is on the Research Team?

David Wright, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8862657/

TEAM-BASED REHABILITATION AFTER TRAUMATIC ... The 10 included studies revealed how people with traumatic brain injury perceived that they struggled on their own for a long time to adapt their daily life.

2. withpower.com withpower.com/trial/phase-brain-concussion-8-2021-4d156

TEaM Intervention for Traumatic Brain Injury (TEaM Trial) In a study involving 90 participants with chronic traumatic brain injury (TBI), the TEAM-TBI program demonstrated high satisfaction rates, with 100% of ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1608645/full

A comprehensive review of rehabilitation approaches for ... These interventions focus on daily living tasks and social participation, and they have been shown to improve outcomes for people with TBI.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01042899

Rehabilitation Research and Training Center for Traumatic ... This study will evaluate the effectiveness of an Internet-based psychosocial treatment in improving problem-solving, communication skills, stress management ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0003999322005330

Update on the Efficacy of Cognitive Rehabilitation After ... This scoping review highlights the persistent and growing interest in cognitive rehabilitation with major methodological improvements in the design of studies.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36183712/

Traumatic brain injury: progress and challenges in prevention ... Around 50% of adult patients with mild TBI presenting to hospital do not recover to pre-TBI levels of health by 6 months after their injury. Fewer than 10% of ...

7. medicaljournalssweden.se medicaljournalssweden.se/jrm-cc/article/view/44355/51850

Early team based neuro-rehabilitation after mild traumatic ... Persons with mTBI reported a greater degree of PCS symptoms 3 months post-injury, and there were no differences found 1 year after injury at ...

8. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2781523

Functional Outcomes Over the First Year After Moderate to ... The percentage of participants with severe TBI and a favorable outcome nearly quadrupled from 12% at 2 weeks to 45% at 3 months, compared with ...

9. cdc.gov cdc.gov/traumaticbraininjury/pdf/tbi_report_to_congress_epi_and_rehab-a.pdf

Traumatic Brain Injury In the United States: Epidemiology ... Examine trends in TBI incidence by injury mechanism and within population subgroups (e.g., children, older adults, and others) by using data systems such as ...