Creation, Implementation, and Analysis of a Seizure Action Plan

Epilepsy Clinical Trial

Official title:

Creation, Implementation, and Analysis of a Seizure Action Plan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995759
• Other study ID #: P00017871
• Status: Completed
• Start date: June 2015
• Est. completion date: April 30, 2019

Study information

• Verified date: August 2019
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Seizures
• Status Epilepticus

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

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