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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

5831 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-11

Study Completion Date

2027-08-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Concussion, Mild Traumatic Brain Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

The study will enroll and follow emergency department clinicians and their patients. Clinicians will be the focus of the intervention.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Clinicians

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

Group Type EXPERIMENTAL

Clinical implementation strategies

Intervention Type OTHER

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

Patients-Survey Cohort

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Patients-Chart Review Only

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Clinical 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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No