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Enrolling by Invitation

NCT Number: NCT06595914

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

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).

Enrolling by Invitation

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Key information

Conditions

Concussion, Mild Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Disease Attributes Emergencies Head Injuries, Closed Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Clinical implementation strategies

Other

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

Primary outcomes

  1. 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)

    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)

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

    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)

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

  3. Self-efficacy to manage mTBI symptoms

    Time frame: Day 1 post-ED visit, Day 30 post-ED visit

    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).

  4. mTBI symptom burden

    Time frame: Day 1 post-ED visit, Day 30 post-ED visit

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

Secondary outcomes

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

    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)

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

  2. Patient-rated mTBI knowledge

    Time frame: Day 30 post-ED visit

    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.

  3. Patient-rated clinical care satisfaction at Day 1

    Time frame: Day 1 post-ED visit

    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?"

  4. Patient-rated clinical care satisfaction at Day 30

    Time frame: Day 30 post-ED visit

    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?"

Other outcomes

  1. Change in clinician ratings to the Acceptability of Intervention Measure

    Time frame: Pre-intervention survey period (study onset through roughly 6 months later); post- intervention survey period (roughly 18 months from study onset to 6 months later)

    ED clinician responses to the Acceptability of Intervention Measure (AIM), a 4 item scale with 5-point Likert-type items scaled from 1 (completely disagree) to 5 (completely agree). Total scores reflect the mean item rating (range 1 to 5); higher scores reflect greater acceptability. (Aim 2 outcome; Aim 1 will characterize pre-implementation baseline data only)

  2. Change in clinician ratings to the Intervention Appropriateness Measure

    Time frame: Pre-intervention survey period (study onset through roughly 6 months later); post- intervention survey period (roughly 18 months from study onset to 6 months later)

    ED clinician responses to the Intervention Appropriateness Measure (IAM), a 4 item scale with 5-point Likert-type items scaled from 1 (completely disagree) to 5 (completely agree). Total scores reflect the mean item rating (range 1 to 5); higher scores reflect greater appropriateness. (Aim 2 outcome; Aim 1 will characterize pre-implementation baseline data only)

  3. Change in clinician ratings to the Feasibility of Intervention Measure

    Time frame: Pre-intervention survey period (study onset through roughly 6 months later); post- intervention survey period (roughly 18 months from study onset to 6 months later)

    ED clinician responses to the Feasibility of Intervention Measure (FIM), a 4 item scale with 5-point Likert-type items scaled from 1 (completely disagree) to 5 (completely agree). Total scores reflect the mean item rating (range 1 to 5); higher scores reflect greater feasibility. (Aim 2 outcome; Aim 1 will characterize pre-implementation baseline data only)

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Ohio State University
  • U.S. Army Medical Research Acquisition Activity
  • University of Kentucky

Registry information

Acronym: EDucate

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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