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

5831 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment Clinical implementation strategies for concussions?

Educational programs on concussions have been shown to improve knowledge and attitudes, which can help reduce the incidence and severity of concussions. Additionally, using educational booklets and guidelines has been found to aid in symptom management and improve the quality of life for those with mild traumatic brain injuries. ^{1 2 3 4 5}

Is the education strategy for concussions safe for humans?

The research articles focus on identifying and preventing adverse events (unintended, potentially harmful events) in pediatric patients, particularly in severe traumatic brain injury and other hospital settings. While they emphasize the importance of safety and prevention strategies, they do not provide specific safety data for education strategies for concussions. ^{6 7 8 9 10}

How is the treatment 'Education Strategies for Concussions' different from other treatments for concussions?

This treatment focuses on improving concussion knowledge through educational resources, which is different from traditional medical treatments that might involve medication or physical therapy. It aims to enhance understanding and prevention of concussions by using multiple educational resources, which has been shown to increase knowledge scores among users. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Concussion Education for Athletes: Symptom Reporting and Safe Return to Sport. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Use of the Progressive Return to Activity Guidelines May Expedite Symptom Resolution After Concussion for Active Duty Military. [2020]

3. England pubmed.ncbi.nlm.nih.gov

A systematic review of the effects of educational interventions on knowledge and attitudes towards concussion for people involved in sport - Optimising concussion education based on current literature. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Discharge Instructions for Concussion: Are We Meeting the Patient Needs? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

American pediatric surgical association journal of pediatric surgery lecture. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

"Good Catch, Kiddo"-Enhancing Patient Safety in the Pediatric Emergency Department Through Simulation. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Neurosurgery outcomes and complications in a monocentric 7-year patient registry. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Adverse events among children in Canadian hospitals: the Canadian Paediatric Adverse Events Study. [2022]

9. Netherlands 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Pros and Cons of 19 Sport-Related Concussion Educational Resources in Canada: Avenues for Better Care and Prevention. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

US Military Healthcare Professionals' Practice, Knowledge, and Misconceptions About Concussion. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Current sport-related concussion teaching and clinical practices of sports medicine professionals. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Implementation of Concussion Management Policies in High Schools: The Critical Role of School Nurses. [2023]

15. United States pubmed.ncbi.nlm.nih.gov

Concussion Education in the School Setting: A Scoping Review. [2022]