Creation, Implementation, and Analysis of a Seizure Action Plan

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Status Epilepticus
• Intervention / Treatment: Other: Seizure Action Plan

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 Type: Observational
• Enrollment (Actual): 288

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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].

Description

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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Seizure Action Plan; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeliness of AED administration	Time from seizure onset to administration of AED	18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): April 30, 2019

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (ESTIMATE): December 16, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Status Epilepticus
• Other Study ID Numbers: P00017871

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO