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Concussion, MildEDucateNCT06595914

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

A study testing Clinical implementation strategies in people with Concussion, Mild and Traumatic Brain Injury, run by Medical College of Wisconsin at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Concussion, Mild, Traumatic Brain Injury
What is being tested?
Clinical implementation strategies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,831 participants
Where
1 siteUnited States
Study dates
11 Sep 2024to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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).

Who cannot join

  • 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).
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  • Indicated Do Not Contact in their research contact preferences.
  • Left the emergency department prematurely (e.g., against medical advice).
  • History of serious health condition that, in the opinion of the investigator, would interfere with engagement in or validity of the survey (e.g., active thought disorder; terminal cancer; dementia).
  • Patients-Chart Review Only:
  • Minors under the age of 18.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

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).

Read the detailed description

The study will address three aims: (1) identify factors that help and hinder providing in-ED education to patients with mTBI prior to discharge; (2) examine the impact of tailored implementation strategies on ED providers' provision of in-ED patient education; and (3) evaluate the impact of providing patient education in the ED and through a mobile Health (mHealth) tool post-discharge on patient-level outcomes after mTBI.

Being tested
Clinical implementation strategies
Keywords
Education, Systems of care, Emergency department, Implementation science
Medical subject headings
Brain Concussion, Brain Injuries, Traumatic, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical implementation strategiesOther

    Clinical implementation strategies, selected based on ED clinician survey/interview findings from Aim 1 using the Implementing Promoting Action on Research Implementation in Health Services (i-PARIHS) implementation science framework

Study groups in NCT06595914
Study groupRoleWhat they receive
CliniciansExperimentalClinician participants will all have access to any clinical implementation strategies that are developed and disseminated in the project.
Receives: Other: Clinical implementation strategies
Patients-Survey CohortNo interventionPatient participants will be observationally followed via survey during the study to monitor patient-reported outcomes.
Patients-Chart Review OnlyNo interventionPatients who are not in the survey study but who meet other eligibility criteria will undergo chart review to provide electronic health record-based outcomes.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Change in the percentage of concussion/mTBI-related encounters for which an mTBI patient handout was documented in the Epic After Visit Summary (Aim 2 outcome)

    Measured: 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)

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

    Change in the percentage of concussion/mTBI-related encounters for which patients reported having received mTBI patient education before ED discharge (Aim 2 outcome)

    Measured: 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)

  3. Self-efficacy to manage mTBI symptoms

    Patient ratings on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Self-Efficacy for Managing Symptoms, a 20-point scale based on 4 Likert-type items with 5 response options each (higher scores = more confidence) (Aim 3 outcome).

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

  4. mTBI symptom burden

    Patient-rated Rivermead Post Concussion Symptoms Questionnaire total score (range 0-64; higher scores = more severe injury-related symptoms) (Aim 3 outcome).

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

Secondary outcomes (4)

  1. Change in percentage of trauma cases resulting in mTBI diagnosis

    Change in the percentage of ED encounters for a traumatic injury resulting in a diagnosis of concussion or mTBI

    Measured: 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)

  2. Patient-rated mTBI knowledge

    Patient-rated mTBI knowledge, measured with a 24-item True/False scale (total score range 0-24; higher scores = greater knowledge). Questions ask about common and uncommon mTBI symptoms and common misconceptions about mTBI signs and recovery.

    Measured: Day 30 post-ED visit

  3. Patient-rated clinical care satisfaction at Day 1

    Collected on a 5-point scale with the options Very Satisfied, Somewhat Satisfied, Neither Satisfied Nor Dissatisfied, Somewhat Dissatisfied, and Very Dissatisfied. The question is "How satisfied are you with the care you received for head injury in the Emergency Department?"

    Measured: Day 1 post-ED visit

  4. Patient-rated clinical care satisfaction at Day 30

    Collected on a 5-point scale with the options Very Satisfied, Somewhat Satisfied, Neither Satisfied Nor Dissatisfied, Somewhat Dissatisfied, and Very Dissatisfied. The question is "How satisfied are you with the care you received for head injury since leaving the emergency department?"

    Measured: Day 30 post-ED visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start11 Sep 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Single group
Model description
The study will enroll and follow emergency department clinicians and their patients. Clinicians will be the focus of the intervention.
Masking
Single blind
Who is masked
Participant
Enrolment
5,831 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06595914
Sponsor's protocol ID
PRO00051478
Other IDs
HT9425-24-1-0376
Acronym
EDucate
Status last verified
Oct 2026
First submitted
10 Sep 2024
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified raw data for the Patient-Survey Cohort will be made available on the Open Data Commons for Traumatic Brain Injury (ODC-TBI)

Publications

  • King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811.

    PubMed 8551320

  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

    PubMed 28851459

Questions about this trial

What is this clinical trial studying?

A study testing Clinical implementation strategies in people with Concussion, Mild and Traumatic Brain Injury, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in patient-level penetration-electronic health record (EHR) (time frame: 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06595914, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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