The "Concussion or Brain Bleed" Trial

Researchers are trying to understand the effect of educating patients and encouraging shared decision making on rates of CT scanning in head injured patients by using an already developed app and observing the effect on the health care provider.

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Key information

Conditions

Head Injury Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18-65 years old
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.

Exclusion criteria

Patients who are pregnant
Non-English speaking
In police custody
Undergoing psychiatric evaluation
Found to have drug or alcohol intoxication

Treatment and study plan

Concussion and Brain Bleed App (CBB)

Other

Tablet based decision aid that encourages shared decision making with the goal of educating patients to reduce unnecessary CT scans

Primary outcomes

Rate of CT Scans

Time frame: 6 months

Number of CT scans performed when using the Concussion and Brain Bleed app

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Shared Decision Making for Patients With Minor Head Injury: The "Concussion or Brain Bleed" Trial

Important dates

Study start: 2019
Primary completion: 2030
Study completion: 2030
First posted: Jun 28, 2019
Registry last updated: May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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