Early Mental Health Management for Concussion

(M4 Trial)

Not currently recruiting at 8 trial locations

Overseen By Noah Silverberg

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Cancer, Multiple sclerosis, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 1

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to address mental health issues that can arise after a mild traumatic brain injury (mTBI), such as a concussion. Researchers are testing the Clinical Practice Guideline Implementation Tool, which helps doctors follow guidelines to proactively manage these mental health challenges. Participants will be in one of two groups: one receiving standard care with slight improvements, and the other using the new guideline tool. Individuals who have recently had a concussion, visited the ER, and live in British Columbia might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in mental health care after mTBI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this clinical practice guideline implementation tool is safe for managing mental health complications after mTBI?

Research has shown that the guidelines tested in this trial are based on strong evidence. Experts developed these guidelines to ensure safe and effective care for patients with mild traumatic brain injury (mTBI). Studies have demonstrated that these guidelines help doctors manage mTBI without increasing patient risk.

Importantly, these guidelines include standard practices that are well-known and have been used in healthcare settings. They are generally safe and well-tolerated. While the trial does not test a new drug or surgery, it focuses on using these guidelines effectively. This approach has a history of safe use in managing mTBI, providing reassurance about its safety in this context. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on implementing a Clinical Practice Guideline Tool for early mental health management in concussions, which is different from the usual approach of managing physical symptoms. Unlike standard care, which often centers on rest and gradual return to activity, this method aims to incorporate mental health strategies early on. By integrating mental health support, the tool could potentially improve recovery times and outcomes for those with concussions, addressing both mental and physical aspects of healing.

What evidence suggests that this clinical practice guideline implementation tool is effective for managing mental health complications after mTBI?

This trial compares two approaches for managing mental health after a mild traumatic brain injury (mTBI). Arm 1 involves minimally enhanced usual care, while Arm 2 uses a guideline implementation tool. Studies have shown that a guideline tool can lower the risk of mental health issues after mTBI. Research indicates that about 1 in 5 people with mTBI experience symptoms lasting more than a month, and these guidelines aim to address that. The tool is based on a thorough review of evidence, having been carefully checked against extensive data. It is designed to help healthcare providers manage mental health issues early after a concussion. This approach could improve the recognition and treatment of mental health problems in individuals recovering from mTBI. ^{1 6 7 8 9}

Who Is on the Research Team?

Noah Silverberg

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-69 in British Columbia who've had a mild traumatic brain injury (mTBI) and visited the emergency department within 72 hours of their injury. They must have a family physician or clinic for follow-up care. Those with serious medical conditions like cancer, multiple sclerosis, or severe mental illnesses like recent schizophrenia are excluded.

Inclusion Criteria

You have signs of a probable mild traumatic brain injury based on a review of your emergency room records and an interview using specific guidelines for diagnosing head injuries.

I went to the emergency room within 3 days of getting injured.

Fluent in English

Exclusion Criteria

I do not have any serious or unstable health conditions like cancer or MS.

Pre-existing unstable/severe mental illness (e.g., schizophrenia requiring hospital admission in past year)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the guideline implementation tool or usual care for managing mental health complications after mTBI

26 weeks

Regular visits as per primary care schedule

Follow-up

Participants are monitored for mental health outcomes and disability at 26 weeks post-injury

4 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Practice Guideline Implementation Tool

Trial Overview

The study tests a guideline implementation tool against generic concussion management information to improve early handling of mental health issues after mTBI. It builds on prior research to support primary care proactive management of these complications.

How Is the Trial Designed?

Group I: Arm 2: Guideline implementation tool Experimental Treatment 1 Intervention

See intervention/treatment description

Group II: Arm 1: Minimally enhanced usual care Active Control 1 Intervention

See intervention/treatment description

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

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]

The study successfully translated and validated the 'Global Trigger Tool-Psychiatry' (GTT-P) for identifying iatrogenic adverse events in psychiatric care in Norway, incorporating insights from both health professionals and service users to enhance its effectiveness.

Implementing the GTT-P can help mental health nurses in Norway and Sweden to better identify potential triggers for adverse events, ultimately improving patient safety and reducing the risk of harm in psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. Okkenhaug, A., Tritter, JQ., Landstad, BJ.[2023]

The Mental Health Trigger Tool (MHTT) was developed to effectively identify adverse events (AEs) and mental health-related patient safety incidents (MHPSIs) in mental health settings, demonstrating a high sensitivity of 98.6% and perfect specificity of 100% based on a review of 515 patient records.

Using the MHTT, researchers found AEs in 19% and MHPSIs in 11% of patient records, indicating its practical utility in enhancing patient safety monitoring in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. Sajith, SG., Fung, DSS., Chua, HC.[2023]

A significant 73% of psychiatrists and nurses in six Flemish psychiatric hospitals reported being involved in at least one adverse event during their careers, with suicide-related incidents being the most impactful for nearly 64% of them.

The study highlights the critical need for timely support for healthcare professionals after adverse events, as those affected are at a higher risk of experiencing further incidents within the first 4-24 hours following the event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious reportable events within the inpatient mental health care: Impact on physicians and nurses. Martens, J., Van Gerven, E., Lannoy, K., et al.[2017]

A pilot study involving 21 family physicians showed that training on new return-to-activity guidelines after concussion significantly increased physicians' knowledge (from 6.3 to 8.8 correct answers out of 10) and adherence to the guidelines (from 25% to 86%).

Despite the positive changes in knowledge and adherence, the study faced challenges in recruitment and retention, indicating that improvements are needed for a larger trial to effectively implement these guidelines in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De-implementing Prolonged Rest Advice for Concussion in Primary Care Settings: A Pilot Stepped Wedge Cluster Randomized Trial. Silverberg, ND., Otamendi, T., Panenka, WJ., et al.[2023]

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

Citations

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The aim is to present a comprehensive but practical guide for the management of patients with TBI. Best practices can improve standards of care as well as ...

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Physical Therapy Evaluation and Treatment After ...

This CPG is to provide a set of evidence-based recommendations for physical therapist management of the wide spectrum of patients who have experienced a ...