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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head Injury Other: Concussion and Brain Bleed App (CBB) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Shared Decision Making for Patients With Minor Head Injury: The "Concussion or Brain Bleed" Trial
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of CT Scans [ Time Frame: 6 months ]
    Number of CT scans performed when using the Concussion and Brain Bleed app


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002505


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Neha Raukar, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Neha P. Raukar, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04002505    
Other Study ID Numbers: 19-000224
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Craniocerebral Trauma
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases