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).
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
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
5,831
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
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
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)
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 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)
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)
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).
Time frame: 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).
Time frame: Day 1 post-ED visit, Day 30 post-ED visit
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
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)
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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.
Time frame: Day 30 post-ED visit
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?"
Time frame: 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?"
Time frame: Day 30 post-ED visit