Back to resultsThe "Concussion or Brain Bleed" Trial
Primary Purpose
Head Injury
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Concussion and Brain Bleed App (CBB)
Sponsored by
About this trial
This is an interventional health services research trial for Head Injury
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Head Injury Subject
Arm Description
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
Outcomes
Primary Outcome Measures
Rate of CT Scans
Number of CT scans performed when using the Concussion and Brain Bleed app
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04002505
Brief Title
The "Concussion or Brain Bleed" Trial
Official Title
Shared Decision Making for Patients With Minor Head Injury: The "Concussion or Brain Bleed" Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
December 2030 (Anticipated)
Study Completion Date
December 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injury
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
370 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Head Injury Subject
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Concussion and Brain Bleed App (CBB)
Intervention Description
Tablet based decision aid that encourages shared decision making with the goal of educating patients to reduce unnecessary CT scans
Primary Outcome Measure Information:
Title
Rate of CT Scans
Description
Number of CT scans performed when using the Concussion and Brain Bleed app
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Raukar, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
The "Concussion or Brain Bleed" Trial
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