Clinical trial NCT06595914: Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Official title: Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Concussion, Mild
Traumatic Brain Injury
Keywords: Education
Systems of care
Emergency department
Implementation science
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research Acquisition Activity
name: Ohio State University
First posted: 2024-09-19
Enrollment: 5831
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The study will enroll and follow emergency department clinicians and their patients. Clinicians will be the focus of the intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

ED clinicians:

• Faculty attending physician, advanced practice professional (APP), resident, fellow, or nurse who practices in an eligible Froedtert \&amp; Medical College of Wisconsin (MCW) emergency department

Patients-Survey Cohort:

* Seen and discharged from a Froedtert \&amp; 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 \&amp; 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).

Exclusion Criteria:

ED clinicians:

• Providers that do not practice in a Froedtert \&amp; Medical College of Wisconsin emergency department.

Patients-Survey Cohort.

* 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.

Primary outcomes:
measure: Change in patient-level penetration-electronic health record (EHR)
timeFrame: 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)
measure: Change in patient-level penetration-patient reported outcome (PRO)
timeFrame: 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)
measure: Self-efficacy to manage mTBI symptoms
timeFrame: Day 1 post-ED visit, Day 30 post-ED visit
measure: mTBI symptom burden
timeFrame: Day 1 post-ED visit, Day 30 post-ED visit
Secondary outcomes:
measure: Change in percentage of trauma cases resulting in mTBI diagnosis
timeFrame: 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)
measure: Patient-rated mTBI knowledge
timeFrame: Day 30 post-ED visit
measure: Patient-rated clinical care satisfaction at Day 1
timeFrame: Day 1 post-ED visit
measure: Patient-rated clinical care satisfaction at Day 30
timeFrame: Day 30 post-ED visit
Other outcomes:
measure: Change in clinician ratings to the Acceptability of Intervention Measure
timeFrame: 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)
measure: Change in clinician ratings to the Intervention Appropriateness Measure
timeFrame: 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)
measure: Change in clinician ratings to the Feasibility of Intervention Measure
timeFrame: 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)
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: 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.
citation: 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.