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

NCT06595914 | Enrolling By Invitation

• 2 other identifiers: PRO00051478HT9425-24-1-0376
• Study Type: interventional
• Target: 5,831
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Concussion, Mild; Traumatic Brain Injury

Keywords

Education; Systems of care; Emergency department; Implementation science

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Change in percentage of trauma cases resulting in mTBI diagnosis

  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 mTBI knowledge

  Day 30 post-ED visit

• Patient-rated clinical care satisfaction at Day 1

  Day 1 post-ED visit

• Patient-rated clinical care satisfaction at Day 30

  Day 30 post-ED visit

Other Outcomes (3)

• Change in clinician ratings to the Acceptability of Intervention Measure

  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

  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

  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)

Study Arms (3)

Clinicians

EXPERIMENTAL

Clinician participants will all have access to any clinical implementation strategies that are developed and disseminated in the project.

Other: Clinical implementation strategies

Patients-Survey Cohort

NO INTERVENTION

Patient participants will be observationally followed via survey during the study to monitor patient-reported outcomes.

Patients-Chart Review Only

NO INTERVENTION

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.

Interventions

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

Clinicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• U.S. Army Medical Research Acquisition Activity: collaborator
• Ohio State University: collaborator

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• 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.

  PMID: 8551320 BACKGROUND

• 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.

  PMID: 28851459 BACKGROUND

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic; Emergencies

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Because the intervention disseminates clinical implementation strategies to clinicians, clinicians will not be masked. Patient participants will be masked to whether their outcomes are being collected pre- versus post-clinician intervention. Patient participants will not be masked with regard to having received the mHealth tool for post-discharge education.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study will enroll and follow emergency department clinicians and their patients. Clinicians will be the focus of the intervention.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)