Epilepsy Visit Planner for Epilepsy

Overseen By Queen Bolden

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: Antiepileptics

Disqualifiers: Under 18, Non-English, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 1

162 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this project is to conduct a trial to assess whether patients that receive a tablet-based waiting room priority communication tool (the "Epilepsy Visit Planner") have improved outcomes compared to patients that do not receive the tool. The project's hypotheses are: * Patients that receive the Epilepsy Visit Planner will have improved patient-provider communication compared to the non-planner group. * Patients that receive the Epilepsy Visit Planner will have improved quality of life scores. * The Epilepsy Visit Planner will score highly on process measures of feasibility and acceptability, demonstrating suitability for future larger scale study. Additionally, there is a related survey project that is not part of the clinical trial and will not be included in this registration information.

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 seems to focus on using a communication tool rather than changing medication.

What data supports the effectiveness of the treatment Epilepsy Visit Planner, Tablet-based Waiting Room Priority Communication Tool for epilepsy?

The research suggests that having a seizure action plan (SAP) can help patients and caregivers manage seizure emergencies more effectively, which may be similar to the benefits of using a communication tool like the Epilepsy Visit Planner. Additionally, telehealth tools have been shown to improve communication and care in pediatric epilepsy, indicating that technology-based solutions can be beneficial in managing epilepsy. ^{1 2 3 4 5}

How does the Epilepsy Visit Planner treatment differ from other epilepsy treatments?

The Epilepsy Visit Planner treatment is unique because it focuses on personalized care planning and communication between patients and healthcare providers, rather than a specific medication or therapy. It emphasizes creating individualized seizure action plans to manage seizure clusters effectively, which is not typically a focus of standard epilepsy treatments. ^{1 2 6 7 8}

Research Team

Chloe Hill, MD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for adults with drug-resistant epilepsy who are being treated at the University of Michigan's Epilepsy clinics. Participants must be able to complete study questionnaires in English and not have cognitive impairments that would prevent this.

Inclusion Criteria

I have epilepsy that doesn't respond to medication.

Participants receiving care through the Epilepsy clinics at the University of Michigan

University of Michigan epilepsy providers

Exclusion Criteria

I am under 18 years old.

I cannot complete questionnaires due to cognitive issues.

My epilepsy is not clearly drug-resistant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline assessments including Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) and other measures

1 week

1 visit (in-person)

Intervention

Participants receive the Epilepsy Visit Planner tool and undergo assessments for feasibility and acceptability

3 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for quality of life and other outcomes 3 months after baseline

3 months

Treatment Details

Interventions

• Epilepsy Visit Planner

Trial Overview The trial is testing a tablet-based tool called the 'Epilepsy Visit Planner' to see if it improves patient-provider communication and quality of life for epilepsy patients, compared to those who don't use the tool.

Participant Groups

Group I: Standard care arm - patient participants Experimental Treatment 1 Intervention

This group will be enrolled first.

Group II: Intervention arm (Epilepsy Visit Planner) - provider participants Experimental Treatment 1 Intervention

Epilepsy providers will be recruited from the University of Michigan (approximately 10 providers).

Group III: Intervention arm (Epilepsy Visit Planner) - patient participants Experimental Treatment 2 Interventions

This group will be enrolled after the standard care arm enrollment is completed.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Findings from Research

Understanding individual seizure clusters is crucial for patients with epilepsy and their caregivers, as it enables prompt action to prevent severe complications like prolonged seizures or status epilepticus.

The introduction of Acute Seizure Action Plans (ASAPs) offers a standardized and customized approach for managing seizure emergencies, providing clear protocols for patients and caregivers to follow during seizure clusters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to use of an acute seizure action plan for seizure clusters and guidance for implementation. Patel, AD., Becker, DA.[2022]

A new telehealth tool was developed to enhance communication among providers, researchers, patients, and families involved in pediatric epilepsy care, addressing the needs of a population facing significant healthcare disparities.

This tool enables in-home telemedicine appointments, which not only improves access to care for patients but also reduces costs for both families and hospital systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multimodal Telehealth Strategy to Improve Pediatric Epilepsy Care. Niemann, MH., Alvarado, MC., Camayd-Muñoz, C., et al.[2020]

Only 30% of the 408 surveyed patients with epilepsy reported having a seizure emergency plan, indicating low adoption despite existing guidance.

Patients with a plan tended to have more severe epilepsy symptoms, including more frequent seizures and higher rates of emergency room visits, suggesting that while plans are more common among those with severe cases, they could benefit all patients with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizure emergency plans: patient results from a cross-sectional epilepsy survey. Wheless, JW., Manjunath, R., Phelps, SJ., et al.[2008]

A new web-based clinical decision tool for evaluating patients with drug-resistant epilepsy was developed and tested for usability, involving end users to ensure it meets their needs.

The study identified key themes from usability testing and focus groups, leading to modifications that aim to improve the tool's implementation in clinical practice, ultimately enhancing care for epilepsy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge translation of an online tool to determine candidacy for epilepsy surgery evaluation. Sauro, KM., Holroyd-Leduc, J., Wiebe, S., et al.[2020]

In a study of 192 parents of children with epilepsy, 62% reported having a Seizure Action Plan (SAP), which is crucial for timely treatment during status epilepticus, especially in those with a history of prior seizures.

A significant 83% of parents expressed interest in a mobile application for SAPs, highlighting a gap between the high interest in digital tools for epilepsy management and the low current usage of available applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizure action plans in the pediatric population with epilepsy: Uptake, determinants, and parental interest in a mobile application. Chiu, M., Peinhof, S., De Guzman, C., et al.[2021]

In conversations about epilepsy, neurologists often used patient-friendly language but avoided the term 'epilepsy' in the U.S., which may hinder clear communication about the condition.

Despite discussing potential side effects of new medications, neurologists rarely addressed the benefits or defined what seizure control meant to patients, indicating a need for improved shared decision-making and goal setting in treatment discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurologist-patient communication about epilepsy in the United States, Spain, and Germany. Stern, JM., Cendes, F., Gilliam, F., et al.[2022]

Telephone consultations are effective for reviewing epilepsy patients, especially those who cannot drive, making it a convenient option for both patients and clinicians.

Implementing a courtesy call before the consultation can enhance efficiency, reduce patient anxiety, and save time for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone review for people with epilepsy. Smith, P.[2018]

A study involving 787 patients with epilepsy across 21 Italian centers revealed that while patients prioritize finding the right medication and minimizing side effects, their priorities do not fully align with those of their physicians, indicating a gap in communication and understanding.

Patients expressed high satisfaction with their doctors but reported dissatisfaction with the information provided about their condition and management, particularly regarding seizure circumstances and emergency care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The management of epilepsy in clinical practice: Do the needs manifested by the patients correspond to the priorities of the caring physicians? Findings from the EPINEEDS Study. Giussani, G., Enia, G., Bianchi, E., et al.[2020]

References

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

Introduction to use of an acute seizure action plan for seizure clusters and guidance for implementation. [2022]

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

A Multimodal Telehealth Strategy to Improve Pediatric Epilepsy Care. [2020]

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

Seizure emergency plans: patient results from a cross-sectional epilepsy survey. [2008]

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

Knowledge translation of an online tool to determine candidacy for epilepsy surgery evaluation. [2020]

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

Seizure action plans in the pediatric population with epilepsy: Uptake, determinants, and parental interest in a mobile application. [2021]

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

Neurologist-patient communication about epilepsy in the United States, Spain, and Germany. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Telephone review for people with epilepsy. [2018]

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

The management of epilepsy in clinical practice: Do the needs manifested by the patients correspond to the priorities of the caring physicians? Findings from the EPINEEDS Study. [2020]