Creation, Implementation, and Analysis of a Seizure Action Plan

Completed

• Conditions: Epilepsy; Status Epilepticus
• Interventions: Other: Seizure Action Plan

• Registration Number: NCT02995759
• Lead Sponsor: Boston Children's Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-16
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

1. 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.
2. 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

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Exclusion Criteria

Exclusion criteria include infantile spasms, not requiring AED to resolve, no hospital admission, invasive EEG monitoring, unclear seizure onset or medication administration times, episode of nonconvulsive status epilepticus.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SE after Seizure Action Plan	Seizure Action Plan	450 patients with status epilepticus after seizure action plan initiation

Primary Outcome Measures

Name	Time	Method
Timeliness of AED administration	18 months	Time from seizure onset to administration of AED

Secondary Outcome Measures

Name	Time	Method
Use of home rescue medications	18 months	Frequency of diastat use in status epilepticus
Seizure frequency	18 months	Parent-reported seizure frequency
Adherence	18 months	Parent-reported knowledge of AED regimen and adherence
Adverse events	18 months	Rate of intubation, allergic reaction, significant hypotension
Effect on patient/parent quality of life	18 months	PedsQL quality of life measure taken by caregiver
Use of appropriately dosed AEDs	18 months	Frequency of AEDs dose within 25% of suggested dose by weight/age
Hospital Admission Rate	18 months	Admission to Hospital and ICU rates

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States