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Enrolling by invitation NCT04002505

The "Concussion or Brain Bleed" Trial

No phase Interventional Head Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Concussion and Brain Bleed App (CBB).
Who it may be relevant to
Registry conditions: Head Injury. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Rate of CT Scans [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT04002505 · 19-000224

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗