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

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tablet-based tool called the Epilepsy Visit Planner to determine if it improves communication between patients with epilepsy and their healthcare providers. The researchers aim to discover whether this tool enhances the quality of life for these patients compared to those who don’t use it. They will also assess the tool's usability and acceptability for future studies. The trial suits adults with medication-resistant epilepsy who receive care at the University of Michigan's epilepsy clinics. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance their healthcare experience.

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 prior data suggests that the Epilepsy Visit Planner is safe?

Research shows that the Epilepsy Visit Planner helps people with epilepsy communicate better with their doctors, potentially improving their health. Although specific safety data from clinical trials is unavailable, it's important to note that this tool is not a drug or physical treatment. As a digital tool used on a tablet, it lacks the side effects associated with medicines.

The Epilepsy Visit Planner aims to facilitate communication between patients and healthcare providers, aiding in better epilepsy management without causing harm. Used in a waiting room, it presents very low risks. Overall, it is considered safe because it doesn't involve physical procedures or interact with the body like a medicine. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Epilepsy Visit Planner is unique because it focuses on enhancing the communication and coordination between patients and their healthcare providers, rather than introducing a new medication. Researchers are excited about this approach because it aims to improve the management of epilepsy through better-planned medical visits. By organizing and optimizing these interactions, the Epilepsy Visit Planner has the potential to lead to more personalized and effective care, which could make a significant difference for those living with epilepsy.

What evidence suggests that the Epilepsy Visit Planner is effective for improving patient-provider communication and quality of life in epilepsy patients?

Research has shown that tools like the Epilepsy Visit Planner, which participants in the intervention arm of this trial will use, can improve communication between patients and healthcare providers. Good communication is crucial for effective epilepsy management. Studies have found that when patients discuss their health priorities, treatment outcomes can improve. Early findings suggest that using these tools might enhance the quality of life for people with epilepsy by ensuring their healthcare needs are clearly understood. This planner aims to make medical visits more productive and focused on what matters most to patients. ^{1 4 6 7 8}

Who Is on the Research Team?

Chloe Hill, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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

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

University of Michigan epilepsy providers

I have epilepsy that doesn't respond to medication.

Exclusion Criteria

I am under 18 years old.

Not University of Michigan epilepsy providers

My epilepsy is not clearly drug-resistant.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11067774

RePORT RePORTER - National Institutes of Health (NIH) | In this study, we will develop and test a mobile health tool for patients with drug-resistant epilepsy to facilitate communication of patient priorities to ...

2. withpower.com withpower.com/trial/phase-epilepsy-6-2023-80896

Epilepsy Visit Planner for Epilepsy · Recruiting Participants ... 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 ...

3. epilepsybehavior.com epilepsybehavior.com/article/S1525-5050(25)00098-8/abstract

Health priorities and treatment preferences of adults with ... Seizure control is a top priority, however there are other important health-related factors that can impact the well-being of a person with epilepsy.

4. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2017.00256/full

Clinic-Based Mobile Health Decision Support to Enhance ... The clinic-based Management Information Decision Support Epilepsy Tool (MINDSET) is a decision-support system founded on theory and empirical evidence. It is ...

5. ilae.org ilae.org/journals/epigraph/epigraph-vol-26-issue-2-spring-2024/seizure-action-plans-more-than-management-tools-for-epilepsy

Seizure action plans: More than management tools for ... A seizure action plan is meant to provide guidance and information for people with epilepsy and their caregivers about the treatment plan.

6. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLViooSi3LzC8tVtJR8nMOMTA1MTAwNTRS0tG1hAEcTEMDPTNTCzMjYx1DcyNzcxMDCwMQ0FHKSy4xMDM2MzQ0N1aKBQCMGxZ3

Save Selected 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11450596/

Key steps and barriers in the journey of patients with epilepsy ... Six key steps on the patient journey were identified: emergency care, diagnosis, drug therapy, follow‐up, referral, and interventional treatment.

8. epilepsybehavior.com epilepsybehavior.com/article/S1525-5050(25)00437-8/pdf

Epilepsy & Behavior This study supports these findings, with participants describing inconsistent involvement in epilepsy management and barriers to communication.