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NCT04002505 Clinical Trial

The "Concussion or Brain Bleed" Trial

Head Injury Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04002505
Other study ID # 19-000224
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 27, 2019
Est. completion date December 2030

Study information
Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 370
Est. completion date December 2030
Est. primary completion date December 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Concussion and Brain Bleed App (CBB)
Tablet based decision aid that encourages shared decision making with the goal of educating patients to reduce unnecessary CT scans

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of CT Scans Number of CT scans performed when using the Concussion and Brain Bleed app 6 months
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