By InvitationNot Applicable

Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury

United States5,831 participantsStarted 2024-09-11

Plain-language summary

The purpose of this study is to develop and validate ways to provide better patient education and clinical management for individuals who go to the emergency department (ED) with concussion or mild traumatic brain injury (mTBI).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: ED clinicians: • Faculty attending physician, advanced practice professional (APP), resident, fellow, or nurse who practices in an eligible Froedtert \& Medical College of Wisconsin (MCW) emergency department Patients-Survey Cohort: * Seen and discharged from a Froedtert \& MCW emergency department. * Age 18 or older. * Has a clinical diagnosis of TBI, as reflected by a relevant International Classification of Disease-10th Edition (ICD-10) code or other evidence (e.g., diagnosis and educational information in the After Visit Summary) * Speaks English or Spanish. Patients-Chart Review Only: * Seen and discharged from a Froedtert \& MCW emergency department. * Age 18 or older. * Has a clinical diagnosis of TBI, as reflected by a relevant ICD-10 code or other evidence (e.g., diagnosis and educational information in the After Visit Summary). Note that for evaluation of Secondary Aim #1 (% trauma patients with an mTBI diagnosis), a broader sample of emergency department patients evaluated for trauma will be evaluated). Exclusion Criteria: ED clinicians: • Providers that do not practice in a Froedtert \& Medical College of Wisconsin emergency department. Patients-Survey Cohort. * In protective custody. * On psychiatric hold. * Is not own decision maker (e.g., activated healthcare power of attorney). * Indicated Do Not Contact in their research contact preferences. * Left the emergency department prematurely (e.g., against medical advic…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in patient-level penetration-electronic health record (EHR)

Timeframe: Pre-intervention baseline period (estimated study onset to 1 year later); post- intervention follow-up period (estimated 18 months from study onset to 1 year later)

Change in patient-level penetration-patient reported outcome (PRO)

Timeframe: Pre-intervention baseline period (estimated study onset to 1 year later); post- intervention follow-up period (estimated 18 months from study onset to 1 year later)

Self-efficacy to manage mTBI symptoms

Timeframe: Day 1 post-ED visit, Day 30 post-ED visit

mTBI symptom burden

Timeframe: Day 1 post-ED visit, Day 30 post-ED visit

Trial details

NCT IDNCT06595914

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

View on ClinicalTrials.gov More Concussion, Mild trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in patient-level penetration-electronic health record (EHR)

Timeframe: Pre-intervention baseline period (estimated study onset to 1 year later); post- intervention follow-up period (estimated 18 months from study onset to 1 year later)

Change in patient-level penetration-patient reported outcome (PRO)

Timeframe: Pre-intervention baseline period (estimated study onset to 1 year later); post- intervention follow-up period (estimated 18 months from study onset to 1 year later)

Self-efficacy to manage mTBI symptoms

Timeframe: Day 1 post-ED visit, Day 30 post-ED visit

mTBI symptom burden

Timeframe: Day 1 post-ED visit, Day 30 post-ED visit