NCT04002505

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
55mo left

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jun 2019Dec 2030

First Submitted

Initial submission to the registry

June 27, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 27, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

11.4 years

First QC Date

June 27, 2019

Last Update Submit

May 7, 2025

Conditions

Head Injury

Outcome Measures

Primary Outcomes (1)

  • Rate of CT Scans

    Number of CT scans performed when using the Concussion and Brain Bleed app

    6 months

Study Arms (1)

Head Injury Subject

EXPERIMENTAL

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)

Interventions

Concussion and Brain Bleed App (CBB)OTHER

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

Head Injury Subject

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who are pregnant
  • Non-English speaking
  • In police custody
  • Undergoing psychiatric evaluation
  • Found to have drug or alcohol intoxication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Officials

  • Neha Raukar, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2019

First Posted

June 28, 2019

Study Start

June 27, 2019

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

May 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)