Creation, Implementation, and Analysis of a Seizure Action Plan
1 other identifier
observational
288
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 14, 2016
CompletedFirst Posted
Study publicly available on registry
December 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedAugust 6, 2019
August 1, 2019
3.9 years
December 14, 2016
August 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Timeliness of AED administration
Time from seizure onset to administration of AED
18 months
Secondary Outcomes (7)
Use of home rescue medications
18 months
Use of appropriately dosed AEDs
18 months
Seizure frequency
18 months
Hospital Admission Rate
18 months
Adverse events
18 months
- +2 more secondary outcomes
Study Arms (2)
SE before Seizure Action Plan
450 patients with status epilepticus prior to seizure action plan initiation
SE after Seizure Action Plan
450 patients with status epilepticus after seizure action plan initiation
Interventions
The action plan will be electronically formatted in the EMR. After electronic creation, the primary neurologist and patient/caregiver will create a patient-specific plan.
Eligibility Criteria
Children aged 1 month to 21 years presenting to Boston Children's Hospital (BCH) with status epilepticus/seizure cluster or who have status epilepticus/seizure cluster during admission at BCH who require antiepileptic(s) for abortion and hospital admission. Status epilepticus is defined as a single seizure lasting 5 minutes or longer; a seizure cluster is defined as 2 or more seizures within 6 hours. Children aged 1 month to 21 years with known seizure disorder followed at Boston Children's Hospital or satellite clinic and enrolled in TriVox/ICISS Health \[(Integrated Clinical Information Sharing System), a web-based platform for tracking symptoms and response to therapy\].
You may qualify if:
- Children aged 1 month to 21 years presenting to Boston Children's Hospital (BCH) with status epilepticus/seizure cluster or who have status epilepticus/seizure cluster during admission at BCH who require antiepileptic(s) for abortion and hospital admission. Status epilepticus is defined as a single seizure lasting 5 minutes or longer; a seizure cluster is defined as 2 or more seizures within 6 hours.
- Children aged 1 month to 21 years with known seizure disorder followed at Boston Children's Hospital or satellite clinic and enrolled in TriVox/ICISS Health
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tobias Loddenkemper, MD
Boston Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 14, 2016
First Posted
December 16, 2016
Study Start
June 1, 2015
Primary Completion
April 30, 2019
Study Completion
April 30, 2019
Last Updated
August 6, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share