Collaborative Care for Post-Traumatic Epilepsy

Overseen By Heidi M. Munger Clary, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Suicidal ideation, Suicide attempt, Alcohol abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether regular phone calls from a healthcare team can improve the quality of life for adults with post-traumatic epilepsy and anxiety or depression. The study will observe the effects over several months.

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 Neurology Based Collaborative Care for Post-Traumatic Epilepsy?

Research on similar collaborative care models, like the Trauma Collaborative Care program, shows that integrating care for emotional and psychological needs can improve outcomes for trauma patients, suggesting that a similar approach might benefit those with post-traumatic epilepsy. Additionally, integrated care models have been effective in increasing access and engagement in psychiatric care for veterans with PTSD and mild traumatic brain injury, indicating potential benefits for coordinated care in neurological conditions. ^{1 2 3 4 5}

Is Collaborative Care for Post-Traumatic Epilepsy safe for humans?

The research does not provide specific safety data for Collaborative Care for Post-Traumatic Epilepsy, but a study on levetiracetam, a medication used in epilepsy care, found it to be safe and well-tolerated in children with traumatic brain injury, with common side effects being headache, fatigue, drowsiness, and irritability. ^{6 7 8 9 10}

How is the Neurology Based Collaborative Care treatment for post-traumatic epilepsy different from other treatments?

The Neurology Based Collaborative Care treatment is unique because it involves a team of professionals from different fields, such as neurology, psychiatry, and social work, working together to provide personalized care for patients with complex needs, unlike traditional treatments that may not integrate such diverse expertise. ^{11 12 13 14 15}

Research Team

Heidi M. Munger Clary, MD, MPH

Principal Investigator

Atrium Health Wake Forest Baptist

Eligibility Criteria

This trial is for adults with post-traumatic epilepsy who have had a traumatic brain injury and are experiencing anxiety or depression. They must be getting care at one of the study sites, agree to follow the study rules, and not be in another treatment study. People with unstable substance abuse, severe other illnesses, cognitive issues affecting survey completion, psychiatric treatment, or serious suicidal thoughts can't join.

Inclusion Criteria

Receiving clinical neurological care at one of the study sites

Stated willingness to comply with all study procedures

Provision of signed and dated informed consent form

Exclusion Criteria

History of past suicide attempt

Unstable drug or alcohol abuse

Current participation in another treatment or intervention study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 24-week neurology-based collaborative care program or usual neurology care

24 weeks

Remote care management calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Neurology Based Collaborative Care
• SOC Neurological care

Trial Overview The trial is testing if special collaborative care calls over 6 months improve life quality compared to usual neurology care for people with post-traumatic epilepsy. It's conducted at two locations and involves 60 participants comparing two types of neurological support.

Participant Groups

Group I: Collaborative Care Experimental Treatment 1 Intervention

Participants in this arm will receive 24 weeks of neurology based collaborative care.

Group II: Standard of Care (SOC) Active Control 1 Intervention

Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

Veterans with traumatic brain injury (TBI) face significant barriers to care coordination, including access to military records (64%) and insufficient time (58%) for care providers, as identified in a study involving 236 VA polytrauma care team members.

Strategies to improve care coordination include promoting teamwork and communication, with 32% of team members emphasizing multidisciplinary collaboration and regular meetings, which are essential for addressing the challenges faced by Veterans with TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and strategies for coordinating care among veterans with traumatic brain injury: a mixed methods study of VA polytrauma care team members. Smith, BM., Martinez, RN., Evans, CT., et al.[2019]

In a study involving 18 semi-structured interviews with individuals and family members affected by severe traumatic brain injury (TBI), it was found that care coordination was largely ineffective, leading to difficulties in accessing services and a lack of comprehensive support.

Only one family member reported successful care coordination, highlighting the need for improved systems to ensure consistent and effective support for TBI patients, given the complexity and long-term nature of their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care coordination experiences of people with traumatic brain injury and their family members in the 4-years after injury: a qualitative analysis. Braaf, S., Ameratunga, S., Christie, N., et al.[2020]

The Trauma Collaborative Care (TCC) program aims to enhance the treatment of trauma patients by integrating early screening and management of emotional distress, which is crucial for improving overall patient outcomes.

In a multicenter study involving 900 patients (481 in the TCC group and 419 in the control group), the effectiveness of the TCC program will be evaluated to see if it leads to lower rates of poor function, depression, and posttraumatic stress disorder compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Trauma Collaborative Care Study (TCCS). Wegener, ST., Pollak, AN., Frey, KP., et al.[2017]

The Integrated Care (IC) model significantly improved access to psychiatric care and engagement among veterans with comorbid PTSD and mild traumatic brain injury (mTBI), as evidenced by increased timely completion of psychiatric consults and higher rates of initiating and completing evidence-based therapies.

In a study reviewing 100 veteran charts, the IC model demonstrated better outcomes compared to the Usual Care (UC) model, suggesting that co-locating psychiatric care within rehabilitation teams can enhance treatment effectiveness for PTSD in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Access to Psychiatric Care for Posttraumatic Stress Disorder in Veterans with Mild Traumatic Brain Injury through Integrated Services. Baig, MR., Tapia, RN., Meraj, A., et al.[2020]

A stepped collaborative care intervention for PTSD and pain management was found to be feasible and acceptable for major trauma survivors in Victoria, Australia, with participants valuing the supportive approach and access to resources.

The intervention led to positive outcomes, including a reduction in PTSD and pain symptoms over 6 months, demonstrating its effectiveness in helping individuals manage their recovery after major trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped collaborative care for pain and posttraumatic stress disorder after major trauma: a randomized controlled feasibility trial. Giummarra, MJ., Reeder, S., Williams, S., et al.[2023]

The study identified 13 specific triggers from medical records that can enhance care coordination for epilepsy patients, potentially improving their health outcomes.

These triggers are designed to address factors that may impact patient safety and overall care, highlighting the importance of tailored interventions in managing epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trigger Development for the Improvement of Neurological Patient Care. Kivekäs, E., Kinnunen, UM., Haatainen, K., et al.[2015]

The study found that an algorithm using ICD-9 diagnosis codes to identify seizure events after influenza vaccination had a high positive predictive value (PPV) of 93.9% in emergency department settings, indicating it is effective for detecting true seizure cases.

The accuracy of the algorithm varied by age group, with the highest PPV in children under 7 years (98.2%) and older adults (92.3%), while it was lower in older children and young adults, suggesting that age and clinical setting significantly influence the identification of seizure events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of seizures among adults and children following influenza vaccination using health insurance claims data. Thyagarajan, V., Su, S., Gee, J., et al.[2021]

A formal collaboration between a community epilepsy center and a tertiary-care epilepsy center led to a significant increase in the number of patients completing the surgical referral process, with a 263% increase in surgical conference referrals and a 254% increase in surgeries performed post-collaboration.

Factors such as higher seizure frequency, shorter travel distance, private insurance, and positive employment status were associated with higher rates of referral completion, suggesting that targeted support for these groups could further enhance the referral process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the epilepsy surgery gap: Impact of community/tertiary epilepsy center collaboration. Peterson, K., LaRoche, S., Cummings, T., et al.[2021]

In a phase II study involving 20 children aged 6-17 with severe traumatic brain injury (TBI), treatment with levetiracetam was found to be safe and well tolerated, with no deaths and a high medication compliance rate of 95%.

Only 2.5% of participants developed posttraumatic epilepsy, suggesting that levetiracetam may effectively reduce the risk of seizures following TBI in at-risk pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of phase II levetiracetam trial following acute head injury in children at risk for posttraumatic epilepsy. Pearl, PL., McCarter, R., McGavin, CL., et al.[2021]

In a study of 5,931 older adults with newly diagnosed epilepsy, most were prescribed anti-seizure medications (ASMs) that align with clinical guidelines, indicating appropriate initial treatment.

However, the study found that ASM polypharmacy (taking multiple medications) significantly increased the risk of injury within one year, highlighting the need for careful prescribing practices to minimize risks in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of first anti-seizure medication choice with injuries in older adults with newly diagnosed epilepsy. Blank, LJ., Agarwal, P., Kwon, CS., et al.[2023]

Patients with epilepsy often face psychiatric comorbidities that can negatively impact their quality of life, seizure control, and overall mortality, highlighting the need for comprehensive care.

Multi-professional teams involving various specialists (neurology, psychiatry, psychology, occupational therapy, and social work) can provide tailored care for patients with complex needs, improving care quality and efficiency while reducing individual workloads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Multi-professional epilepsy teams including psychiatric expertise]. Bendix, M., Lindbom, U.[2019]

The study involved participatory action research with two groups of epilepsy care practitioners—hospital-based epilepsy specialist nurses (ESNs) and community-based resource officers (CROs)—to improve collaboration in patient care.

Findings revealed that despite shared goals, existing biases and unclear roles hindered effective coordination, but through dialogue and self-reflection, the groups began to form collaborative relationships that could enhance care for people with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Igniting intersectoral collaboration in chronic disease management: a participatory action research study on epilepsy care in Ireland. Varley, J., Kiersey, R., Power, R., et al.[2021]

A nationwide survey of 957 medical facilities in Japan revealed that epilepsy centers (EC) provide more comprehensive care related to epilepsy surgery compared to large hospitals, but struggle with psychiatric services and patient referrals.

Despite their capabilities, ECs face significant challenges in patient referrals, with 64% of referral difficulties attributed to patient or family refusal, leading to overcrowding at these specialized centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Status of epilepsy care delivery and referral in clinics, hospitals, and epilepsy centers in Japan: A nationwide survey. Tokumoto, K., Terada, K., Kawaguchi, N., et al.[2023]

Effective organization of medical care for epilepsy can significantly enhance the quality of care for patients, addressing the serious psychological, cognitive, and social impacts of the condition.

Two management models have been identified: a nurse-based liaison service and specialized epilepsy departments, both of which are complementary, but current evidence does not clearly indicate which model is superior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What organisation to improve health care management of patients with partial refractory epilepsy?]. Villeneuve, N.[2007]

Effective communication between emergency physicians, neurologists, and primary care physicians is crucial for managing patients with breakthrough seizures in the emergency department, as it helps ensure continuity of care.

Emergency physicians should be more comfortable using newer-generation antiepileptic drugs (AEDs) and collaborate with neurologists to make informed decisions about adjusting AED regimens, which can lead to better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of breakthrough seizures in the emergency department: continuity of patient care. Montouris, GD., Jagoda, AS.[2019]

References

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

Barriers and strategies for coordinating care among veterans with traumatic brain injury: a mixed methods study of VA polytrauma care team members. [2019]

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

Care coordination experiences of people with traumatic brain injury and their family members in the 4-years after injury: a qualitative analysis. [2020]

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

The Trauma Collaborative Care Study (TCCS). [2017]

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

Enhancing Access to Psychiatric Care for Posttraumatic Stress Disorder in Veterans with Mild Traumatic Brain Injury through Integrated Services. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Stepped collaborative care for pain and posttraumatic stress disorder after major trauma: a randomized controlled feasibility trial. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Trigger Development for the Improvement of Neurological Patient Care. [2015]

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

Identification of seizures among adults and children following influenza vaccination using health insurance claims data. [2021]

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

Addressing the epilepsy surgery gap: Impact of community/tertiary epilepsy center collaboration. [2021]

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

Results of phase II levetiracetam trial following acute head injury in children at risk for posttraumatic epilepsy. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Association of first anti-seizure medication choice with injuries in older adults with newly diagnosed epilepsy. [2023]

11. Sweden pubmed.ncbi.nlm.nih.gov

[Multi-professional epilepsy teams including psychiatric expertise]. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Igniting intersectoral collaboration in chronic disease management: a participatory action research study on epilepsy care in Ireland. [2021]

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

Status of epilepsy care delivery and referral in clinics, hospitals, and epilepsy centers in Japan: A nationwide survey. [2023]

14. France pubmed.ncbi.nlm.nih.gov

[What organisation to improve health care management of patients with partial refractory epilepsy?]. [2007]

15. England pubmed.ncbi.nlm.nih.gov

Management of breakthrough seizures in the emergency department: continuity of patient care. [2019]