What is the mechanism of action of this treatment?

The most common treatments for Traumatic Brain Injury (TBI) include patient education and shared decision-making, which empower patients to be actively involved in their care, potentially reducing unnecessary CT scans and associated risks. This approach helps patients understand their condition and treatment options, leading to more informed decisions. Additionally, treatments such as cognitive rehabilitation aim to improve cognitive functions through structured exercises, while medications like anti-inflammatory drugs reduce brain swelling and prevent further injury. These treatments are crucial as they address both the immediate and long-term effects of TBI, improving patient outcomes and quality of life.

What side effects are associated with this type of intervention?

Common treatments for Traumatic Brain Injury (TBI) include medications, rehabilitation therapies, and occasionally surgical interventions. Medications like pain relievers and anti-seizure drugs can cause side effects such as drowsiness, dizziness, and gastrointestinal issues. Rehabilitation therapies may lead to temporary discomfort or fatigue. Surgical interventions, though less frequent, carry risks including infection, bleeding, and adverse reactions to anesthesia. Additionally, frequent use of CT scans exposes patients to radiation, which has a small long-term risk of cancer.

What prior FDA approvals exist?

There are no specific FDA-approved drugs mentioned for the treatment of Traumatic Brain Injury (TBI) in the provided context. However, the trial involving a Patient Education and Shared Decision Making App aims to enhance patient knowledge and involvement in decision-making, which can potentially reduce unnecessary CT scans. This approach emphasizes the importance of educating patients and encouraging shared decision-making in the management of head injuries.

What other types of research exist?

Promising alternatives for TBI patient education and shared decision-making include: 1) Interactive tablet-based educational interventions, which have shown improvements in patient knowledge and engagement. 2) Mobile applications designed to teach concussion-related health knowledge, demonstrating significant knowledge gains and positive user feedback. 3) Telemedicine platforms that facilitate remote consultations and follow-up care, improving access to care and patient outcomes. These alternatives leverage technology to enhance patient education and involvement in their care decisions.

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CBB App for Traumatic Brain Injury

N/A

Waitlist Available

Led By Neha Raukar, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18-65 years old

Be older than 18 years old

Must not have

Non-English speaking patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an app that educates head injury patients and helps them make decisions with their doctors about getting a CT scan. The goal is to see if this approach reduces unnecessary scans and improves patient care.

Who is the study for?

This trial is for adults aged 18-65 who come to the Emergency Department with a head injury from the past day and are low risk for serious brain injury. They must speak English, not be pregnant, in police custody, undergoing psychiatric evaluation or intoxicated.

What is being tested?

The study tests an app called Concussion and Brain Bleed App (CBB) that educates patients about head injuries. It aims to see if using this app affects how often doctors order CT scans for these patients.

What are the potential side effects?

Since this trial involves an educational app rather than medication, there are no direct medical side effects. However, participants may experience stress or anxiety related to learning about their health condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of CT Scans

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Head Injury SubjectExperimental Treatment1 Intervention

Subjects that present to the Emergency Department with a blunt head injury within the past 24 hours, determined to be low risk by the Canadian CT Head Rules (CCHR), and are being considered for a head CT by the treating provider will use the shared decision making tool Concussion and Brain Bleed app (CBC) with their clinician

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Traumatic Brain Injury (TBI) include patient education and shared decision-making, which empower patients to be actively involved in their care, potentially reducing unnecessary CT scans and associated risks. This approach helps patients understand their condition and treatment options, leading to more informed decisions. Additionally, treatments such as cognitive rehabilitation aim to improve cognitive functions through structured exercises, while medications like anti-inflammatory drugs reduce brain swelling and prevent further injury. These treatments are crucial as they address both the immediate and long-term effects of TBI, improving patient outcomes and quality of life.

Randomized Controlled Trials of Rehabilitation Services in the Post-acute Phase of Moderate and Severe Traumatic Brain Injury - A Systematic Review.