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The "Concussion or Brain Bleed" Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002505
Recruitment Status : Enrolling by invitation
First Posted : June 28, 2019
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Neha P. Raukar, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date March 13, 2020
Actual Study Start Date  ICMJE June 27, 2019
Estimated Primary Completion Date December 31, 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
Rate of CT Scans [ Time Frame: 6 months ]
Number of CT scans performed when using the Concussion and Brain Bleed app
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The "Concussion or Brain Bleed" Trial
Official Title  ICMJE Shared Decision Making for Patients With Minor Head Injury: The "Concussion or Brain Bleed" Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Head Injury
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Head Injury Subject
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: Other: Concussion and Brain Bleed App (CBB)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 27, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2030
Estimated Primary Completion Date December 31, 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002505
Other Study ID Numbers  ICMJE 19-000224
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Neha P. Raukar, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neha Raukar, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP