Educational Video for Concussion

Overseen By Christina Dollar, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Inova Health Care Services

Disqualifiers: Neurological disorder, Previous mTBI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will develop and validate a new ED/Urgent Care discharge educational video that provides positive assurance about mild traumatic brain injury (mTBI) recovery for patients with mTBI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Positive Assurance for concussion?

The research suggests that educational interventions, like video instructions, can improve understanding and management of concussions, which may indirectly support the effectiveness of Positive Assurance as a treatment by enhancing patient knowledge and confidence in managing their condition. ^{1 2 3 4 5}

How does the educational video for concussion differ from other treatments for concussions?

The educational video for concussion is unique because it focuses on improving athletes' intention to report concussions by making the learning experience more enjoyable, especially for those who did not enjoy previous education programs. Unlike traditional knowledge-based programs, this approach emphasizes changing behavior and attitudes towards concussion reporting. ^{3 6 7 8 9}

Eligibility Criteria

This trial is for young individuals aged 13-21 who have recently experienced a mild traumatic brain injury (mTBI) with symptoms like dizziness or headaches. They must be diagnosed by an emergency physician within 72 hours of the injury and can't have had a severe mTBI, previous neurosurgery, neurological disorders, or significant findings on brain scans.

Inclusion Criteria

Has received a medical diagnosis of mTBI from an emergency physician at the IFH Pediatrics ED within 72 hours of injury

You have been diagnosed with a mild traumatic brain injury (mTBI) by a doctor within 72 hours of your injury.

I have had a head or body injury causing symptoms like dizziness or headaches.

Exclusion Criteria

I had a mild traumatic brain injury in the last 6 months.

You were unconscious for more than 30 minutes after the injury.

You experience delays in your development.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the Positive Assurance Discharge Video Educational Intervention or Standard of Care ED/Urgent Care Discharge Instructions

1 month

Baseline visit and follow-up visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment using various assessments like ImPACT, PCSS, VOMS, BRAC, and STAI

1 month

Treatment Details

Interventions

• Positive Assurance

Trial Overview The study is testing an educational video that provides positive assurance about recovery from mTBI. The goal is to develop and validate this video as part of the discharge process for patients treated in the emergency department.

Participant Groups

Group I: ED/Urgent Care Positive Assurance Discharge Video Educational Intervention (EDUC). Experimental Treatment 1 Intervention

The video intervention will be administered to participants that are randomly assigned to the EDUC group. In addition, current standard of care discharge instructions will also be provided to the participant. This EDUC intervention will consist of a brief, three to five-minute informative video message from the clinical neuropsychologist at the Inova Sports Medicine Concussion Program. In addition to the viewing of the video after ED/Urgent Care discharge, all participants will be instructed to view the video at least once every 24 - 48 hours prior to their visit to the concussion clinic.

Group II: Standard of Care ED/Urgent Care Discharge Instructions (Treatment as Usual: TAU ) Active Control 1 Intervention

The Acute Concussion Evaluation (ACE) Care plan in place at the Inova PED/GoHealth Urgent Care sites is the standard-of-care discharge instruction for individuals with mTBI. This care plan provides patient and caregiver education about mTBI and emphasizes the monitoring of symptoms, signs of deterioration that may warrant urgent medical attention, and encourages the patient to follow up with their physician for follow up. Participants who are randomized into the TAU group will receive this standard of care treatment in video format as well, however these participants will not be given a QR code to watch the intervention video.

Who Is Running the Clinical Trial?

Inova Health Care Services

Lead Sponsor

Trials

80

Recruited

22,700+

References

1. United States pubmed.ncbi.nlm.nih.gov

Educating Providers in Return-to-Play Suggested Guidelines Postconcussion. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Video Discharge Instructions for Patients With Mild Traumatic Brain Injury in the Emergency Department: A Randomized Controlled Trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Delivering Evidence-Based Online Concussion Education to Medical and Healthcare Professionals: The Concussion Awareness Training Tool (CATT). [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Do family physicians, emergency department physicians, and pediatricians give consistent sport-related concussion management advice? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Improved Concussion Discharge Instructions in a Pediatric Emergency Department. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Athlete Enjoyment of Prior Education Moderates change in Concussion-Reporting Intention after Interactive Education. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Concussion Education for Athletes: Symptom Reporting and Safe Return to Sport. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Concussion Education in the School Setting: A Scoping Review. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Development of a Peer Education Program to Improve Concussion Knowledge and Reporting in Collegiate Athletes. [2021]