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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Traumatic Brain Injury; Concussion, Mild
• Intervention / Treatment: Other: Clinical implementation strategies

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.

• Study Type: Interventional
• Enrollment (Estimated): 5831
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinicians; Clinician participants will all have access to any clinical implementation strategies that are developed and disseminated in the project.	Other: Clinical implementation strategies; 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
No Intervention: Patients-Survey Cohort; Patient participants will be observationally followed via survey during the study to monitor patient-reported outcomes.
No Intervention: Patients-Chart Review Only; Patients 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Change in the percentage of concussion/mTBI-related encounters for which patients reported having received mTBI patient education before ED discharge (Aim 2 outcome)	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	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).	Day 1 post-ED visit, Day 30 post-ED visit
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).	Day 1 post-ED visit, Day 30 post-ED visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)
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?"	Day 1 post-ED visit
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?"	Day 30 post-ED visit
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.	Day 30 post-ED visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinician ratings to the Acceptability of Intervention Measure	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)	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)
Change in clinician ratings to the Intervention Appropriateness Measure	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)	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)
Change in clinician ratings to the Feasibility of Intervention Measure	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)	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)

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Ohio State University; University of Kentucky; U.S. Army Medical Research Acquisition Activity

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Education; Emergency department; Implementation science; Systems of care
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Disease Attributes; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Pathological Conditions, Signs and Symptoms; Brain Injuries, Traumatic; Emergencies; Brain Concussion
• Other Study ID Numbers: PRO00051478; HT9425-24-1-0376 (Other Grant/Funding Number: U.S. Army Medical Research Acquisition Activity)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified raw data for the Patient-Survey Cohort will be made available on the Open Data Commons for Traumatic Brain Injury (ODC-TBI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No