Positive Assurance and mTBI

Inova Health Care Services

Status: Invitation-only

Conditions: MTBI - Mild Traumatic Brain Injury; Concussion, Mild Traumatic Brain Injury

Treatments: Other: Positive Assurance

Study type: Interventional

Funder types: Other

Identifiers

NCT04982731

U20-05-4050

Details and patient eligibility

About

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

Full description

The research team will investigate the effect of this new Positive Assurance discharge intervention video on state anxiety and clinical recovery outcomes in patients with mTBI. A sample of adolescent and young adult patients (13-21yrs) will be recruited for participation that present with a potential mTBI diagnosis and receive specialty referral to the Inova Sports Medicine Concussion Program for follow-up care. Investigators will employ a randomized controlled trial (RCT) to enroll two groups of mTBI patients: 1) a group that receives the video intervention (EDUC), and 2) a group that receives standard discharge instructions (i.e., treatment as usual: TAU).

Enrollment: 229 estimated patients

Sex: All

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

COHORT 1 (no longer being recruited):

INCLUSION CRITERIA:

Subjects must meet the following criteria in order to be eligible to participate:

1. 13-21 years
2. Has sustained an external force to head or body resulting in neurological symptoms and at least one reported symptom is attributed to the mTBI (e.g., dizziness, confusion, headache, postural instability, light/noise sensitivity, nausea)
3. Has receive a medical diagnosis of mTBI from an emergency physical at the IFH Pediatrics ED or Inova-GoHealth Urgent Care clinic within 72 hours of injury
4. Is able to provide remote informed written consent (parent) and assent

EXCLUSION CRITERIA:

Subjects who meet any of the following criteria will not be eligible to participate:

1. Loss of consciousness > 30 minutes in conjunction with the injury
2. Glasgow Coma Scale (GCS) score < 13
3. Has sustained a previous mTBI within the past 6 months
4. Has a neurological disorder (e.g., epilepsy)
5. Has a positive finding on brain imaging (e.g., CT, MRI) that suggests a severe closed head or open injury involving any structural damage or abnormality (e.g., fracture, subdural hematoma)
6. Has a previous history of neurosurgery
7. Does not speak English as a primary language
8. Requires admission to the hospital
9. Has developmental delays
10. Prisoner
11. Pregnant*
12. Has been previously enrolled in the study
13. Members of same household will not be included as they may determine their group assignment if more than one person from same household is included and assigned to different groups.

COHORT 2:

INCLUSION CRITERIA:

Subjects must meet the following criteria in order to be eligible to participate:

1. 13-21 years
2. Has scheduled an appointment to be evaluated at the Inova Sports Medicine Concussion Clinic for a traumatic closed head injury that has occurred within the past 30 days
3. The time between study enrollment and the initial clinical visit is at least two days
4. Is able to provide remote informed written consent (parent) and assent

EXCLUSION CRITERIA:

Subjects who meet any of the following criteria will not be eligible to participate:

1. Loss of consciousness > 30 minutes in conjunction with the injury
2. Glasgow Coma Scale (GCS) score < 13
3. Has sustained a previous mTBI within the past 6 months
4. Has a neurological disorder (e.g., epilepsy)
5. Has a positive finding on brain imaging (e.g., CT, MRI) that suggests a severe closed head or open injury involving any structural damage or abnormality (e.g., fracture, subdural hematoma)
6. Has a previous history of neurosurgery
7. Does not speak English as a primary language
8. Requires admission to the hospital
9. Has developmental delays
10. Prisoner
11. Pregnant*
12. Has been previously enrolled in the study
13. Members of same household will not be included as they may determine their group assignment if more than one person from same household is included and assigned to different groups.

WITHDRAWAL CRITERIA (BOTH COHORTS):

1. Upon examination, if the clinical team determines that a participant did not sustain/cannot confirm a concussion, the subject will be withdrawn from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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229 participants in 2 patient groups

Positive Assurance Discharge Video Educational Intervention (EDUC).

Experimental group

Description:

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.

Treatment:

Other: Positive Assurance

Standard of Care Instructions (Treatment as Usual: TAU )

No Intervention group

Description:

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.