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

Medical College of Wisconsin

Status: Invitation-only

Conditions: Traumatic Brain Injury; Concussion, Mild

Treatments: Other: Clinical implementation strategies

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06595914

HT9425-24-1-0376 (Other Grant/Funding Number)

PRO00051478

Details and patient eligibility

About

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).

Full 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.

Enrollment: 5,831 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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5,831 participants in 3 patient groups

Clinicians

Experimental group

Description:

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

Treatment:

Other: Clinical implementation strategies

Patients-Survey Cohort

No Intervention group

Description:

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

Patients-Chart Review Only

No Intervention group

Description:

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.