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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing post-traumatic epilepsy to determine if it can improve quality of life over six months. Participants will receive either regular neurology care or a special program called Neurology Based Collaborative Care, which includes additional support calls from a care team. The goal is to discover if the extra support improves overall well-being. Adults with epilepsy following a traumatic brain injury who experience anxiety or depression may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative care approaches that could enhance well-being.

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 collaborative care program is safe for post-traumatic epilepsy patients?

Research has shown that neurology-based collaborative care is generally safe for patients. This approach has been tested in similar situations and is well-tolerated. For instance, studies on managing anxiety and depression in people with post-traumatic epilepsy have not found any serious side effects.

The collaborative care model coordinates various healthcare services to improve patient outcomes. By focusing on organizing and managing care rather than using new drugs or invasive procedures, it usually carries a low risk of side effects.

This trial aims to enhance quality of life through better care coordination, making it a safe choice for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about neurology-based collaborative care for post-traumatic epilepsy because it offers a more integrated approach than traditional treatments. Unlike the standard of care, which typically involves separate clinic visits, prescriptions, and testing, this method combines medical care with tailored support from a team of health professionals working together. This holistic approach aims to improve patient outcomes by addressing both the neurological and psychological aspects of epilepsy, potentially leading to more effective management of the condition.

What evidence suggests that the Neurology Based Collaborative Care could be effective for post-traumatic epilepsy?

Research has shown that working with a team of healthcare providers can improve life for people with post-traumatic epilepsy. In this trial, participants in the Collaborative Care arm will receive neurology-based collaborative care, addressing both physical and emotional needs. Studies have found that this approach can help reduce anxiety and depression, common in people with epilepsy. Early results suggest that this method not only boosts mental health but also increases overall life satisfaction. Therefore, this team-based care appears promising for helping those with post-traumatic epilepsy live better lives. Meanwhile, participants in the Standard of Care (SOC) arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals. ^{1 3 4 5 6}

Who Is on the Research Team?

Heidi M. Munger Clary, MD, MPH

Principal Investigator

Atrium Health Wake Forest Baptist

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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 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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05353452

Study Details | Collaborative Care in Posttraumatic Epilepsy This is a 2-site trial comparing a 24 week neurology-based collaborative care program to usual neurology care among a total of 60 adults with post-traumatic ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39535875/

Collaborative Care to Improve Quality of Life for Anxiety ... The Collaborative Care for Posttraumatic Epilepsy (CoCarePTE) trial aims to evaluate the effectiveness (improvement in emotional quality of life) and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05353452?tab=history&a=8

Record History | ver. 8: 2023-11-07 | NCT05353452 Questionnaire to help determine acceptability of collaborative care from neurologists' perspectives. Score ranges from 5 to 20, with higher score indicating ...

4. med.upenn.edu med.upenn.edu/PTERC/collaborative-care-to-improve-quality-of-life-for-anxiety-and-depression-in-post-traumatic-epilepsy

Collaborative Care to Improve Quality of Life for Anxiety ... In this study, we will assess a neurology-oriented collaborative care intervention among 60 adults with post-traumatic epilepsy and anxiety or depression who ...

5. scienceopen.com scienceopen.com/document?vid=e665dfc4-2b73-4d61-a0a8-906da4b15a9e

Collaborative Care to Improve Quality of Life for Anxiety ... The Collaborative Care for Posttraumatic Epilepsy (CoCarePTE) trial aims to evaluate the effectiveness (improvement in emotional quality of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11602765/

Collaborative Care to Improve Quality of Life for Anxiety ... The Collaborative Care for Posttraumatic Epilepsy (CoCarePTE) trial aims to evaluate the effectiveness (improvement in emotional quality of life) and ...