Concussion, Mild, Traumatic Brain Injury
Conditions
Keywords
Education, Systems of care, Emergency department, Implementation science
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.
Interventions
OTHERClinical 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
Sponsors
Medical College of Wisconsin
U.S. Army Medical Research Acquisition Activity
Ohio State University
University of Kentucky
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
The study will enroll and follow emergency department clinicians and their patients. Clinicians will be the focus of the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient-level penetration-electronic health record (EHR) | 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) | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | Change in the percentage of ED encounters for a traumatic injury resulting in a diagnosis of concussion or mTBI |
| Patient-rated mTBI knowledge | 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. |
| Patient-rated clinical care satisfaction at Day 1 | 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?" |
| Patient-rated clinical care satisfaction at Day 30 | 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?" |
Countries
United States
Outcome results
None listed