Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT02995759
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2016-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creation, Implementation, and Analysis of a Seizure Action Plan
Sponsor:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
Creation, Implementation, and Analysis of a Seizure Action Plan
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Data strongly suggests that aggressive and early treatment of status epilepticus (SE) is crucial for seizure abortion and prevention of long-term neurologic sequelae. We propose the creation of a seizure action plan, an intervention aimed to guide daily medication use, outline pre-hospital seizure first aid and rescue medication use, and direct emergency personnel in patients' individualized SE medication algorithm, with implementation through the electronic medical record. We hypothesize that the seizure action plan will promote daily medication adherence, increase use of home rescue mediation, and improve timeliness of AED (antiepileptic drug) delivery, length of hospital stay, and ICU admission rate in episodes of status epilepticus.
Detailed Description:
The purpose of this study is the creation, implementation, and analysis of a seizure action plan, an intervention aimed to guide daily medication use, outline pre-hospital seizure first aide and rescue medication use, and direct emergency personnel in patients' individualized status epilepticus medication algorithm, with implementation through the electronic medical record. After creation of the action plan, the primary neurologist and patient/caregiver will create a patient-specific plan. The action plan will be reviewed and updated as necessary at each regularly scheduled primary neurology clinic visit. Two studies will aim at analyzing the effectiveness of this intervention. A prospective observational cohort study of patient care process and outcomes 18 months before and 18 months after initiation of seizure action plan will analyze patients with status epilepticus requiring hospital admission and/or status epilepticus that occurs during admission at BCH and measure rescue medication prescription and application patterns, timeliness of medication administration during SE, use of appropriately dosed AEDs, rate of intubation, significant hypotension, allergic reaction, and other adverse events, and hospital length of stay and rate of ICU admissions. A second prospective observational cohort study of patient outcome variables 18 months before and 18 months after initiation of a seizure action plan obtained through parent-reported ICISS (Integrated Clinical Information Sharing System)/Trivox data, a web-based platform for tracking symptoms and response to therapy, will measure rescue medication prescription and application patterns, interval seizure frequency, effect on patient and parent quality of life, parent knowledge of AED regimen, and parent self-reported medication adherence.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: