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Clinical Trials/NCT06595914
NCT06595914
Enrolling by Invitation
N/A

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

Medical College of Wisconsin1 site in 1 country5,831 target enrollmentSeptember 11, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Concussion, Mild
Sponsor
Medical College of Wisconsin
Enrollment
5831
Locations
1
Primary Endpoint
Change in patient-level penetration-electronic health record (EHR)
Status
Enrolling by Invitation
Last Updated
9 months ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
September 11, 2024
End Date
August 1, 2027
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lindsay Nelson

Professor

Medical College of Wisconsin

Eligibility Criteria

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.

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:

Outcomes

Primary Outcomes

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)

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)

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).

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

  • Patient-rated clinical care satisfaction at Day 30(Day 30 post-ED visit)
  • 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)

Study Sites (1)

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