Collaborative Care for Post-Traumatic Epilepsy
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: Suicidal ideation, Suicide attempt, Alcohol abuse, others
No Placebo Group
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.
12345Is 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.
678910How 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.
1112131415Eligibility 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
+4 more
Exclusion Criteria
History of past suicide attempt
Unstable drug or alcohol abuse
Current participation in another treatment or intervention study
+4 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Collaborative CareExperimental Treatment1 Intervention
Participants in this arm will receive 24 weeks of neurology based collaborative care.
Group II: Standard of Care (SOC)Active Control1 Intervention
Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Atrium Health Wake Forest BaptistWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
References
Barriers and strategies for coordinating care among veterans with traumatic brain injury: a mixed methods study of VA polytrauma care team members. [2019]Veterans who experience traumatic brain injury (TBI) may have long-term needs placing a premium on well-coordinated care. This study aimed to (1) identify barriers to care coordination for Veterans with TBI; and (2) describe strategies used by VA polytrauma care team members to coordinate care for Veterans with TBI.
Care coordination experiences of people with traumatic brain injury and their family members in the 4-years after injury: a qualitative analysis. [2020]Care coordination experiences of people with traumatic brain injury and their family members 4-years after injury: A qualitative analysis.
The Trauma Collaborative Care Study (TCCS). [2017]Previous research suggests that the care provided to trauma patients could be improved by including early screening and management of emotional distress and psychological comorbidity. The Trauma Collaborative Care (TCC) program, which is based on the principles of well-established models of collaborative care, was designed to address this gap in trauma center care. This article describes the TCC program and the design of a multicenter study to evaluate its effectiveness for improving patient outcomes after major, high-energy orthopaedic trauma at level 1 trauma centers. The TCC program was evaluated by comparing outcomes of patients treated at 6 intervention sites (n = 481) with 6 trauma centers where care was delivered as usual (control sites, n = 419). Compared with standard treatment alone, it is hypothesized that access to the TCC program plus standard treatment will result in lower rates of poor patient-reported function, depression, and posttraumatic stress disorder.
Enhancing Access to Psychiatric Care for Posttraumatic Stress Disorder in Veterans with Mild Traumatic Brain Injury through Integrated Services. [2020](i) To describe an integrated model of psychiatric care for the treatment of posttraumatic stress disorder (PTSD) in veterans with mild traumatic brain injury (mTBI). (ii) To evaluate access to and engagement in psychiatric care among veterans with comorbid PTSD and mTBI after implementation of an Integrated Care (IC) model compared to the previous Usual Care (UC). 100 randomly selected charts, 50 from each of UC and IC were reviewed in this non-concurrent case- control study. Polytrauma Network Site (PNS), an outpatient rehabilitation clinic, for veterans who suffered from brain and other traumatic injuries at an urban VA Polytrauma Rehabilitation Center. Veterans receiving treatment for mTBI symptoms by the rehabilitation team were referred for medication management for PTSD to UC and IC. Co-located access to psychiatric care for medication management as part of the interdisciplinary team with the goal of expediting rehabilitation and functional recovery. Number of consults for psychiatric care for medication management scheduled and completed within 30 days, and number of veterans offered, initiating, and completing evidence-based psychotherapies for PTSD in UC compared to IC. After implementation of IC there were significant improvements in timely completion of consults and patient engagement with a psychiatrist. There also were improvements in number of referrals, initiation, and completion of evidence-based psychotherapies for the treatment of PTSD. IC within the PNS shows promise as an effective care model for increasing access and engagement in care for veterans with comorbid PTSD/mTBI. Future research is needed to examine the utility of this model in other sites.
Stepped collaborative care for pain and posttraumatic stress disorder after major trauma: a randomized controlled feasibility trial. [2023]To examine feasibility and acceptability of providing stepped collaborative care case management targeting posttraumatic stress disorder (PTSD) and pain symptoms after major traumatic injury.
Trigger Development for the Improvement of Neurological Patient Care. [2015]By analyzing medical records, we developed triggers for epilepsy patients' care coordination. Thirteen triggers with potential to affect patient care outcomes and safety were found.
Identification of seizures among adults and children following influenza vaccination using health insurance claims data. [2021]Post-licensure surveillance of adverse events following vaccination or prescription drug use often relies on electronic healthcare data to efficiently detect and evaluate safety signals. The accuracy of seizure-related diagnosis codes in identifying true incident seizure events in vaccine safety studies is influenced by factors such as clinical setting of diagnosis and age. To date, most studies of post-vaccination seizure have focused on pediatric populations. More information is needed on how well seizure can be identified in adults and children using algorithms that rely on electronic healthcare data.
Addressing the epilepsy surgery gap: Impact of community/tertiary epilepsy center collaboration. [2021]To assess whether a formal collaboration between a non-surgical, community epilepsy center and a surgical, tertiary-care epilepsy center can improve patient progress throughout the pre-surgical referral process, and to elucidate predictors of referral completion among inter-center referrals. The inter-center referral process was tracked, and the number of patients completing surgical conference (primary outcome) and epilepsy surgery at the tertiary center were collected and compared in the 45-month immediate pre/post-collaboration periods. Demographic and clinical variables were collected on post-collaboration inter-center patient referrals to explore factors associated with completion of the referral process. Compared to the pre-collaboration period, the proportion of tertiary center epilepsy surgery conference patients referred from the community epilepsy center increased from 3/88 to 14/113 (263% increase, p = .01) during the post-collaboration period. The proportion of patients completing surgery via the community to tertiary referral process increased from 2/63 pre-collaboration to 8/71 post-collaboration (254% increase, p = .04). Referral completion was associated with higher seizure frequency, shorter travel distance, private insurance status and positive employment status (p < 0.05). Collaboration agreements between community and tertiary-care epilepsy centers may improve patient completion of the epilepsy surgery referral process. Implementation of similar programs at other centers may be beneficial in reducing the epilepsy surgery gap.
Results of phase II levetiracetam trial following acute head injury in children at risk for posttraumatic epilepsy. [2021]Posttraumatic seizures develop in up to 20% of children following severe traumatic brain injury (TBI). Children ages 6-17 years with one or more risk factors for the development of posttraumatic epilepsy, including presence of intracranial hemorrhage, depressed skull fracture, penetrating injury, or occurrence of posttraumatic seizure were recruited into this phase II study. Treatment subjects received levetiracetam 55 mg/kg/day, b.i.d., for 30 days, starting within 8 h postinjury. The recruitment goal was 20 treated patients. Twenty patients who presented within 8-24 h post-TBI and otherwise met eligibility criteria were recruited for observation. Follow-up was for 2 years. Forty-five patients screened within 8 h of head injury met eligibility criteria and 20 were recruited into the treatment arm. The most common risk factor present for pediatric inclusion following TBI was an immediate seizure. Medication compliance was 95%. No patients died; 19 of 20 treatment patients were retained and one observation patient was lost to follow-up. The most common severe adverse events in treatment subjects were headache, fatigue, drowsiness, and irritability. There was no higher incidence of infection, mood changes, or behavior problems among treatment subjects compared to observation subjects. Only 1 (2.5%) of 40 subjects developed posttraumatic epilepsy (defined as seizures >7 days after trauma). This study demonstrates the feasibility of a pediatric posttraumatic epilepsy prevention study in an at-risk traumatic brain injury population. Levetiracetam was safe and well tolerated in this population. This study sets the stage for implementation of a prospective study to prevent posttraumatic epilepsy in an at-risk population.
Association of first anti-seizure medication choice with injuries in older adults with newly diagnosed epilepsy. [2023]Epilepsy incidence increases exponentially in older adults, who are also at higher risk of adverse drug effects. Anti-seizure medications (ASM) may be associated with sedation and injuries, but discontinuation can result in seizures. We sought to determine whether there was an association between prescribing non-guideline concordant ASM and subsequent injury as this could inform care models.
[Multi-professional epilepsy teams including psychiatric expertise]. [2019]Epilepsy has a diverse spectrum of consequences that can necessitate multi-professional cooperation in order to guarantee a high level of care. Psychiatric comorbidity is common, which influences quality of life, seizure control and mortality. Multi-professional teams, with participation from neurology, psychiatry, psychology, occupational therapy and social work, can together tailor the individual care for patients with complex needs. Close cooperation among team members increases quality and efficiency of care and reassurance for patients and their relatives while decreasing the work load for individual team members.
Igniting intersectoral collaboration in chronic disease management: a participatory action research study on epilepsy care in Ireland. [2021]Models of care developed to improve the lives of people with chronic diseases highlight integrated care as essential to meeting their needs and achieving person (patient)-centered care (PCC). Nevertheless, barriers to collaborative practice and siloed work environments persist. To set in motion some groundwork for intersectoral collaboration this study brought two expert groups of epilepsy care practitioners together to engage in participatory action research (PAR). The expert practitioner groups were hospital-based epilepsy specialist nurses (ESNs) and community-based resource officers (CROs). The PAR highlighted, that while the participants share a mutual interest in caring for people with epilepsy, underdeveloped CRO-ESN relationships, arising from unconscious bias and ambiguity can result in missed opportunities for optimal care coordination with consequent potential for unnecessary replication and waste of finite resources. However, through dialogue and critical self-reflection, a growing emotional connection between the disciplines evolved over the course of the PAR. This allowed for buds of collaboration to develop with CROs and ESNs working together to tackle some of the key barriers to their collaboration.
Status of epilepsy care delivery and referral in clinics, hospitals, and epilepsy centers in Japan: A nationwide survey. [2023]Collaboration among medical facilities is crucial to deliver comprehensive epilepsy care to a diverse and large population of people with epilepsy. We conducted a survey among medical facilities of various sizes throughout Japan to investigate the status of epilepsy care delivery, functioning, and referral.
[What organisation to improve health care management of patients with partial refractory epilepsy?]. [2007]Epilepsy is a common and serious neurological condition. It may have severe psychological, cognitive and social consequences. A good organisation of medical care is able to improve the quality of care offered to people with epilepsy. Only the Anglo-Saxon literature has attempted to analyse this problem. Two models of management has been described: epilepsy specialist nurse-based liaison service between primary and secondary/tertiary care and department specialized in epilepsy. These types of service are complementary but it is difficult to determine the best model the currently available results.
Management of breakthrough seizures in the emergency department: continuity of patient care. [2019]Epilepsy is a chronic disorder requiring long-term management. Communication between emergency physicians, neurologists, and primary care physicians (PCPs) is especially critical for the continuity of care for patients who present in an emergency department (ED) with a breakthrough seizure. Therefore, maximizing communication between the emergency physician and the PCP is of the utmost importance. The emergency physician, who is on the front line, must gather the information necessary to identify the underlying cause of the seizure and decide whether the pharmaceutical management must be changed.