CBB App for Traumatic Brain Injury

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Non-English, Police custody, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a mobile app can assist patients with head injuries in making informed decisions about obtaining a CT scan. The Concussion and Brain Bleed App (CBB) is used alongside a doctor to enhance communication and decision-making. Suitable participants have experienced a mild head injury within the past 24 hours, are not considered high risk, and are contemplating a CT scan. Individuals aged 18 to 65 who meet these criteria may find this trial suitable. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve patient care and decision-making.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that the Concussion and Brain Bleed App is safe for head injury patients?

Research shows that the Concussion and Brain Bleed (CBB) app aids doctors and patients in deciding on CT scans for head injuries. Studies have found that emergency rooms use this app to guide decisions for patients with minor head injuries.

There are no safety concerns because it is a digital tool, not a drug or device applied to the body. It aims to enhance communication and decision-making between patients and healthcare providers, meaning it has no side effects like those from medications or medical treatments.

In summary, the CBB app is considered safe as it serves as an educational and decision-making tool, not a physical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Concussion and Brain Bleed App (CBB) because it offers a new approach to managing traumatic brain injuries right in the emergency department. Unlike traditional methods that rely heavily on CT scans, this app is a shared decision-making tool designed to help clinicians and patients determine the need for a CT scan based on real-time data and guidelines like the Canadian CT Head Rules. This could reduce unnecessary CT scans, minimizing radiation exposure and healthcare costs, while still ensuring patient safety. By integrating technology into patient care, the CBB app represents a shift towards more personalized and efficient treatment strategies for head injuries.

What evidence suggests that the Concussion and Brain Bleed App is effective for head injury patients?

Research shows that the Concussion and Brain Bleed App (CBB), used by participants in this trial, helps determine if a CT scan is necessary for head injuries. Studies have found that using this app in emergency rooms improves the patient experience and assists doctors in deciding on the need for a CT scan. The app educates patients and promotes shared decision-making, potentially reducing unnecessary scans and leading to better outcomes. By providing clear information, the app helps both patients and doctors make informed decisions about care after a head injury. ^{1 3 5 6 7}

Who Is on the Research Team?

Neha Raukar, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am considered low risk for head injury but might need a head CT scan.

I came to the ER with a head injury from a blunt force within the last day.

Exclusion Criteria

You are currently having a mental health assessment.

People who are currently in police custody.

Patients found to have drug or alcohol intoxication

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants use the Concussion and Brain Bleed app with their clinician to make shared decisions about CT scanning

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Concussion and Brain Bleed App (CBB)

Trial Overview 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.

How Is the Trial Designed?

Group I: Head Injury Subject Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. digital.ahrq.gov digital.ahrq.gov/sites/default/files/docs/citation/k08hs021271-melnick-final-report-2018.pdf

Clinical Decision Support for Mild Traumatic Brain Injury To describe the use of the Concussion or Brain Bleed app in a high-volume ED and to establish preliminary efficacy estimates on patient experience, clinician ...

2. withpower.com withpower.com/trial/phase-craniocerebral-trauma-5-2019-0f712

CBB App for Traumatic Brain Injury · Info for Participants This trial is testing an app that educates head injury patients and helps them make decisions with their doctors about getting a CT scan.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11943846/

Traumatic Brain Injury and Artificial Intelligence Clinical outcomes from TBI are highly variable, ranging from full recovery to severe disability or death. Outcome variability makes it challenging to develop AI ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772529423010238

Blood biomarkers for traumatic brain injury: A narrative ... A blood-based biomarker (BBBM) test could help to better stratify patients with traumatic brain injury (TBI), reduce unnecessary imaging, to detect and treat ...

5. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/traumatic-brain-injury

Traumatic Brain Injury Clinical Trials The specific aim of this project is to systematically and prospectively collect and collate data derived from the clinical care of concussion patients seen at ...

6. sciencedirect.com sciencedirect.com/org/science/article/pii/S2291522217001887

Tablet-Based Patient-Centered Decision Support for Minor ... The objective of this study was to describe the use of the Concussion or Brain Bleed app in a high-volume ED and to establish preliminary ...

7. newsroom.uw.edu newsroom.uw.edu/news-releases/smartphone-app-pupilscreen-aims-help-detect-concussions

Smartphone app PupilScreen aims to help detect concussions PupilScreen aims to allow anyone with a smartphone to objectively screen for concussion and other brain injuries on the spot — whether on the sidelines of a ...