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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to create and test an educational video that offers positive assurance about recovery from mild traumatic brain injury (mTBI). Participants will either watch this new video or follow the standard care instructions given after a concussion. The trial targets individuals aged 13–21 who have recently received a concussion diagnosis from a doctor. As an unphased trial, this study allows participants to contribute to innovative educational approaches that could enhance recovery experiences for others.

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 prior data suggests that this educational video is safe for patients with mTBI?

Research shows that educational videos about concussion recovery are safe to watch. These videos aim to reassure individuals about recovery after a mild head injury. No reports of negative effects have emerged from watching these videos, as they are purely informational.

Past studies found that adding video information to regular care did not alter recovery outcomes from concussion symptoms. This suggests that patients generally handle the videos well. Since this trial involves watching a short video, safety concerns should not arise. The goal is to foster a more positive outlook on recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the educational video intervention for concussion because it offers a new way to reinforce patient education consistently at home. Unlike standard care, which typically involves verbal and written instructions, this video provides a visually engaging and easy-to-understand message from a clinical neuropsychologist. This method not only helps ensure that patients and their caregivers understand the necessary steps for recovery but also encourages regular viewing, which could lead to better adherence to care instructions and potentially faster recovery.

What evidence suggests that this educational video is effective for mTBI recovery?

This trial will compare the effects of an educational video intervention with standard care instructions for mild traumatic brain injury (mTBI). Research has shown that adding video information to usual care for mTBI does not significantly improve symptoms after a concussion. One study found that providing video instructions upon hospital discharge did not reduce symptom severity. However, videos can still serve as a helpful and engaging way to share important information. While the videos might not directly reduce symptoms, they can aid patients in understanding their condition and what to expect during recovery. This understanding can enhance patients' confidence and knowledge about their healing process. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: 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. 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 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, 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+

University of Arkansas, Fayetteville

Collaborator

Trials

24

Recruited

2,100+

Citations

1. withpower.com withpower.com/trial/phase-brain-injuries-traumatic-7-2021-114d3

Educational Video for Concussion · Info for Participants This study will develop and validate a new ED/Urgent Care discharge educational video that provides positive assurance about mild traumatic brain injury (mTBI) ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33618811/

Effect of Video Discharge Instructions for Patients With Mild ... Conclusion: Severity of postconcussion symptoms in patients with mild traumatic brain injury did not improve by adding video information to standard care.

3. researchgate.net researchgate.net/publication/353541361_The_Effect_of_Written_and_Video_Discharge_Instructions_After_Mild_Traumatic_Brain_Injury_on_Healthcare_Costs_and_Productivity_Costs

The Effect of Written and Video Discharge Instructions After ... Conclusion: This study showed that the implementation of flyer (and video) discharge instructions for patients with mTBI who present at the ED ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34320553/

The Effect of Written and Video Discharge Instructions After ... This study showed that the implementation of flyer (and video) discharge instructions for patients with mTBI who present at the ED increased ...

5. uknowledge.uky.edu uknowledge.uky.edu/cgi/viewcontent.cgi?article=1342&context=dnp_etds

Evaluation of a Concussion Management and Discharge ... The training consisted of a brief introduction to the brain with the inclusion of complications of sustained head injuries such as concussions. This training ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9841394/

Enhanced education for adult patients with persistent post ... We conducted a randomized clinical trial to determine if an e-learning intervention can enhance recovery in adult patients with persistent post-concussion ...

7. youtube.com youtube.com/watch?v=55u5Ivx31og

Concussion / Traumatic Brain Injury (TBI) Tua Football Injury - This 3D medical animation explains the mechanism for mild traumatic brain injury, which includes concussion injuries. ... | Concussion Patient ...

8. cdc.gov cdc.gov/heads-up/communication-resources/videos.html

Concussion Videos | HEADS UP Watch the pros tell their stories, the experts give their insights, and families, both teens and their parents, discuss how concussion has changed their lives.