Early Mental Health Management for Concussion

(M4 Trial)

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

537 Participants Needed

Trial Summary

What is the purpose of this trial?

Mental health problems frequently complicate recovery from mild traumatic brain injury (mTBI) but are under-recognized and under-treated. Our research program aims to identify evidence-based strategies for closing this knowledge-practice gap. Building on a successful pilot trial, the reseachers will evaluate the effectiveness of a clinical practice guideline implementation tool designed to support proactive management of mental health complications after mTBI in primary care.

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 data supports the effectiveness of the treatment Clinical Practice Guideline Implementation Tool for early mental health management for concussion?

Research suggests that using guideline implementation tools can help reduce mental health complications after mild traumatic brain injury by ensuring consistent and proactive care. This approach has the potential to improve patient outcomes by translating evidence-based guidelines into practice. ^{1 2 3 4 5}

Is the Early Mental Health Management for Concussion treatment generally safe for humans?

The research articles focus on identifying and measuring adverse events in mental health and neuropsychiatry settings, which suggests that safety tools are being developed to monitor and manage potential risks. However, specific safety data for the Early Mental Health Management for Concussion treatment itself is not provided. ^{6 7 8 9 10}

How is the Clinical Practice Guideline Implementation Tool treatment for concussion different from other treatments?

This treatment is unique because it focuses on using a guideline implementation tool to proactively detect and manage mental health issues after a concussion, which is often overlooked. It aims to improve consistency in care by ensuring that healthcare providers follow evidence-based guidelines, potentially reducing the risk of mental health complications. ^{1 2 3 4 11}

Research Team

Noah Silverberg

Principal Investigator

University of British Columbia

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Do concussion clinicians use clinical practice guidelines? [2021]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of interventions for the improvement of mental health and well-being post-concussion: a systematic review. [2023]

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

De-implementing Prolonged Rest Advice for Concussion in Primary Care Settings: A Pilot Stepped Wedge Cluster Randomized Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a guideline implementation tool for supporting management of mental health complications after mild traumatic brain injury in primary care: protocol for a randomised controlled trial. [2022]

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

Use of a multi-level mixed methods approach to study the effectiveness of a primary care progressive return to activity protocol after acute mild traumatic brain injury/concussion in the military. [2019]

6. Spain pubmed.ncbi.nlm.nih.gov

Serious reportable events within the inpatient mental health care: Impact on physicians and nurses. [2017]

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

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

8. England 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. [2023]

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

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]

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

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. [2023]

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

Multidisciplinary Concussion Management: A Model for Outpatient Concussion Management in the Acute and Post-Acute Settings. [2020]