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Behavioural Intervention

Education Strategies for Concussions (EDucate Trial)

N/A

Waitlist Available

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients-Chart Review Only: Seen and discharged from a Froedtert & MCW emergency department, Age 18 or older, Has a clinical diagnosis of TBI

Be older than 18 years old

Must not have

Patients-Chart Review Only: Minors under the age of 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to find better ways to educate and manage patients who go to the emergency department with a concussion or mild traumatic brain injury."

Who is the study for?

This trial is for individuals who have experienced a concussion or mild traumatic brain injury (mTBI) and are seeking treatment in the emergency department. Specific eligibility criteria details were not provided.

What is being tested?

The study aims to develop and test strategies for improving patient education and clinical management during hospital stays and after discharge for those with concussions or mTBI.

What are the potential side effects?

Since this trial focuses on educational and clinical management strategies rather than medication, there are no direct side effects from drugs being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or older, was treated at a Froedtert & MCW emergency department, and diagnosed with TBI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 and my medical information is being reviewed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in patient-level penetration-electronic health record (EHR)

Change in patient-level penetration-patient reported outcome (PRO)

Self-efficacy to manage mTBI symptoms

+1 more

Secondary study objectives

Change in percentage of trauma cases resulting in mTBI diagnosis

Patient-rated clinical care satisfaction at Day 1

Patient-rated clinical care satisfaction at Day 30

+1 more

Other study objectives

Change in clinician ratings to the Acceptability of Intervention Measure

Change in clinician ratings to the Feasibility of Intervention Measure

Change in clinician ratings to the Intervention Appropriateness Measure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: CliniciansExperimental Treatment1 Intervention

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

Group II: Patients-Survey CohortActive Control1 Intervention

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

Group III: Patients-Chart Review OnlyActive Control1 Intervention

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.

0 / 2Eligibility criteria met