The "Concussion or Brain Bleed" Trial

NCT ID: NCT04002505

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-27

Study Completion Date

2030-12-31

Brief Summary

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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

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Conditions

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Head Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Concussion and Brain Bleed App (CBB)

Intervention Type OTHER

Tablet based decision aid that encourages shared decision making with the goal of educating patients to reduce unnecessary CT scans

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Neha P. Raukar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neha Raukar, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials (open in google chrome)

Other Identifiers

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19-000224

Identifier Type: -

Identifier Source: org_study_id

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