Improving Patient Communication About SUDEP (NCT03502759) | Clinical Trial Compass
CompletedNot Applicable
Improving Patient Communication About SUDEP
United States103 participantsStarted 2018-06-14
Plain-language summary
Children with generalized tonic-clonic seizures (GTCS) have about a 1 in 4500 of succumbing to sudden unexpected death in epilepsy (SUDEP). For that reason, the American Academy of Neurology recommends that clinicians caring for these children make their families aware of this small but important risk and provide appropriate supportive follow-up resources. Moreover, existing evidence suggests that children with poorly controlled GTCS have a strikingly increased odds of SUDEP, 3-24 fold, raising the importance of improving seizure control.
Clinicians caring for these patients have multiple issues to address in the typical visit. The investigators propose to use information technology to help providers assure that addressing SUDEP is incorporated into their routine care. The investigators have developed the Child Health Improvement through Computer Automation system (CHICA), a computer based clinical decision support system for pediatric care. CHICA captures patient reported data in the waiting room and prioritizes clinical advice to the physician through the electronic health record (EHR).
CHICA is used in five primary care clinics in the Eskenazi health system where it supports general pediatric care. The goal of this project is to test the effectiveness of a SUDEP module in this setting where CHICA is already in use - with a future goal of developing a full suite of CHICA modules for child neurologists.
Who can participate
Age range
0 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Parent or Guardian of a child seen at one of five clinics in the Eskenazi health care system for which the child has had at least 2 lifetime motor seizures.
Exclusion Criteria:
Inability of the subject to understand the survey
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial was specifically studying how well parents remember being counseled about SUDEP, has it changed the way you approach having that conversation with families — and can we have a thorough SUDEP discussion right now?
2This trial focused on parent recall of SUDEP counseling, which suggests that information about SUDEP risk is sometimes not fully retained — what are the most important things you want me to actually remember and act on when it comes to SUDEP and my child's epilepsy?
3Because this was a communication-focused study rather than a treatment trial, it doesn't test new medications or devices — so what current standard-of-care options are available to us for reducing SUDEP risk, and should those be our immediate focus?
4The trial is now completed — is there anything from its findings about how SUDEP counseling should be delivered that you've applied to your practice, and can you share what the research suggested about the best way to communicate this risk?
5Since SUDEP can be a frightening topic, how do you recommend we stay informed and keep the conversation going over time, rather than treating it as a one-time discussion?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.