Education Strategies for Concussions

(EDucate Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Psychiatric hold, Dementia, Terminal cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve patient education and management in the emergency department for concussions or mild traumatic brain injuries (mTBI). Researchers are developing and testing new clinical implementation strategies to help healthcare providers deliver better care and information to these patients. The trial includes different groups: one where clinicians use the new strategies, another where patients complete surveys, and a third where patient records are reviewed. Individuals diagnosed with a traumatic brain injury and discharged from a Froedtert & Medical College of Wisconsin emergency department might be a good fit for the trial. As an unphased trial, this study offers patients the opportunity to contribute to innovative strategies that could enhance future emergency care for mTBI.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these clinical implementation strategies are safe for concussion management?

Research has shown that the methods used in managing concussions are generally safe. These methods help doctors and nurses provide better care and information to patients with concussions or mild brain injuries by focusing on improving medical guidelines and decision-making to support recovery.

No known negative effects are directly linked to these methods. They aim to enhance care by guiding doctors and patients in following the best recovery steps. These methods do not involve new medicines or physical procedures, so they avoid the risks associated with new drug treatments. Essentially, they aim to make the healthcare system work better for patients with concussions.

Since this trial focuses on improving education and management methods, rather than testing new drugs or treatments, the usual safety concerns with new medical treatments do not apply. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve how concussions are managed through innovative education strategies. Unlike traditional treatments that focus solely on the medical management of symptoms, this approach emphasizes equipping clinicians with new implementation strategies to enhance care. By focusing on education and the dissemination of knowledge, the trial seeks to improve patient outcomes through better-informed healthcare providers. This could lead to a more efficient and effective recovery process for patients suffering from concussions.

What evidence suggests that these clinical implementation strategies are effective for concussions?

Research has shown that learning about concussions can be very helpful. One study found that athletes who participated in concussion education programs reported concussions more frequently, with a 6.8% increase immediately after the program and an 11.4% increase a month later. Another review highlighted that these programs enhance knowledge about concussions and can influence reporting frequency. Additionally, increased knowledge and the right attitude can help reduce concussion risk and improve management. These findings suggest that education plays a key role in better handling concussions and mild traumatic brain injuries (mTBI). In this trial, clinicians will access clinical implementation strategies developed and disseminated in the project, while patient participants will be observed through surveys or chart reviews to monitor outcomes. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

Exclusion Criteria

ED clinicians: Providers that do not practice in a Froedtert & Medical College of Wisconsin emergency department

Patients-Survey Cohort: On psychiatric hold, Is not own decision maker, Indicated Do Not Contact in their research contact preferences, Left the emergency department prematurely, History of serious health condition that would interfere with engagement in or validity of the survey

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-ED Education

Identify factors that help and hinder providing in-ED education to patients with mTBI prior to discharge

Pre-intervention baseline period (estimated study onset to 1 year later)

Post-discharge Education

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

Post-intervention follow-up period (estimated 18 months from study onset to 1 year later)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinical implementation strategies

Trial Overview 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.

How Is the Trial Designed?

Group I: Clinicians Experimental Treatment 1 Intervention

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

Group II: Patients-Survey Cohort Active Control 1 Intervention

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

Group III: Patients-Chart Review Only Active Control 1 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.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

U.S. Army Medical Research Acquisition Activity

Collaborator

Trials

26

Recruited

10,500+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

A simulation training program significantly improved the self-efficacy of medical students and interns in identifying and reporting patient safety hazards, indicating its effectiveness as a training tool.

Participants were particularly good at recognizing patient misidentification hazards, but often missed safety issues related to electronic health records (EHRs), highlighting a need for targeted interventions in that area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Good Catch, Kiddo"-Enhancing Patient Safety in the Pediatric Emergency Department Through Simulation. Shaikh, U., Natale, JE., Till, DA., et al.[2023]

A prospective patient registry for neurosurgical procedures, implemented in 2013, successfully captured data from 8226 patients across nearly 12,000 surgeries, highlighting its effectiveness in tracking complications over time.

The Clavien-Dindo grade (CDG) was validated as a reliable method for classifying complications, showing a clear correlation with patient outcomes such as performance status and length of hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosurgery outcomes and complications in a monocentric 7-year patient registry. Sarnthein, J., Staartjes, VE., Regli, L.[2022]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

In a study of 3669 hospitalized children in Canada, the overall rate of adverse events was found to be 9.2%, with a higher frequency in academic pediatric centers compared to community hospitals (adjusted odds ratio of 2.98).

While the incidence of preventable adverse events was similar across hospital types, nonpreventable adverse events were more common in academic centers, highlighting a need for improved safety measures, especially related to surgical procedures and diagnostic errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among children in Canadian hospitals: the Canadian Paediatric Adverse Events Study. Matlow, AG., Baker, GR., Flintoft, V., et al.[2022]

In a study of 193 pediatric patients with severe traumatic brain injury (sTBI), 53% experienced at least one adverse event (AE), highlighting the high risk of complications in this vulnerable population.

The most common AE was decubitus ulcers, and patients with AEs had longer hospital stays and higher costs, indicating that identifying and preventing AEs can improve patient safety and reduce healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of adverse events in pediatric severe traumatic brain injury patients to target evidence-based prevention for increased performance improvement and patient safety. Charyk Stewart, T., Luong, K., Alharfi, I., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8582631/

Evaluating the Effect of Concussion-Education Programs ... A total sample of athletes improved in concussion-reporting intention at immediate and 1-month follow-ups (mean improvements = 6.8% and 11.4%, respectively).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7216205/

A Systematic Review of the Effectiveness of Concussion ... This systematic review examined the content and efficacy (changes in knowledge, impact on concussion incidence) of concussion education programs for coaches ...

3. researchgate.net researchgate.net/publication/392824101_Effectiveness_of_Concussion-Education_Strategies_Implemented_With_High_School_Athletes_A_Critically_Appraised_Topic

Effectiveness of Concussion-Education Strategies ... Clinical Bottom Line : Primary-level prevention concussion education is effective at increasing concussion knowledge and concussion-reporting ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/07853890.2024.2393760

Full article: An initial assessment of an opinion leader ... This study assessed an intervention to decrease concussion risk and improve concussion management through improving concussion-related knowledge, attitudes, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1440244025001008

Where's your head at? Perceptions and utilisation of ... This study aims to identify and analyse the concussion prevention and rehabilitation strategies currently implemented across different rugby contexts.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11537489/

A Scoping Review of Implementation Science Studies in the ... Hence, the objectives of this scoping review were to characterize implementation science studies in the field of TBI by (1) identifying the ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S000399931931305X

Management of Concussion and Mild Traumatic Brain Injury Careful diagnostic assessment and proactive clinical management is essential to maximizing recovery. Patient education, return to activity guidance, and symptom ...

8. liebertpub.com liebertpub.com/doi/full/10.1089/neu.2021.0067

A Review of Implementation Concepts and Strategies ... TBI guidelines aim to advise clinical decision-making surrounding the diagnosis, management, and/or treatment of injury to improve patient outcomes. The TBI ...

9. thelancet.com thelancet.com/article/S1474-4422(22)00309-X/fulltext

Traumatic brain injury: progress and challenges in ... Around 50% of adult patients with mild TBI presenting to hospital do not recover to pre-TBI levels of health by 6 months after their injury. Fewer than 10% of ...

10. cdc.gov cdc.gov/traumatic-brain-injury/publications/index.html

Publications | Traumatic Brain Injury & Concussion View publications and reports on traumatic brain injury and concussion. This includes CDC MMWR and other journal articles, fact sheets, and reports to Congress.