EpilepsyNCT02995759
Creation, Implementation, and Analysis of a Seizure Action Plan
An observational study of Epilepsy and Status Epilepticus, run by Boston Children's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 1 month to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Status Epilepticus
- What is being tested?
- Seizure Action Plan
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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].
Who may be able to join
- 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
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Epilepsy, Status Epilepticus
- Being tested
- Seizure Action Plan
- Medical subject headings
- Epilepsy, Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seizure Action PlanOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Seizure Action Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeliness of AED administration
Time from seizure onset to administration of AED
Measured: 18 months
Secondary outcomes (7)
Use of home rescue medications
Frequency of diastat use in status epilepticus
Measured: 18 months
Use of appropriately dosed AEDs
Frequency of AEDs dose within 25% of suggested dose by weight/age
Measured: 18 months
Seizure frequency
Parent-reported seizure frequency
Measured: 18 months
Hospital Admission Rate
Admission to Hospital and ICU rates
Measured: 18 months
Adverse events
Rate of intubation, allergic reaction, significant hypotension
Measured: 18 months
Effect on patient/parent quality of life
PedsQL quality of life measure taken by caregiver
Measured: 18 months
Adherence
Parent-reported knowledge of AED regimen and adherence
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startJun 2015
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Loddenkemper, Boston Children's Hospital
- Investigators
- Tobias Loddenkemper, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995759
- Sponsor's protocol ID
- P00017871
- Status last verified
- Aug 2019
- First submitted
- 14 Dec 2016
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation, Implementation, and Analysis of a Seizure Action Plan
- ClinicalTrials.gov ID
- NCT02995759
- Acronym / sponsor ID
- P00017871
- Conditions
- Epilepsy, Status Epilepticus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SE before Seizure Action Plan | – | –450 patients with status epilepticus prior to seizure action plan initiation |
| SE after Seizure Action Plan | – | Other: Seizure Action Plan450 patients with status epilepticus after seizure action plan initiation |
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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].
Key inclusion criteria (3 listed)
- 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
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seizure Action PlanThe action plan will be electronically formatted in the EMR. After electronic creation, the primary neurologist and patient/caregiver will create a patient-specific plan. | Other | SE after Seizure Action Plan |
Primary outcome
Timeliness of AED administration
Time frame: 18 months
Time from seizure onset to administration of AED
7 secondary outcomes
Use of home rescue medications
Time frame: 18 months
Use of appropriately dosed AEDs
Time frame: 18 months
Seizure frequency
Time frame: 18 months
Hospital Admission Rate
Time frame: 18 months
Adverse events
Time frame: 18 months
Effect on patient/parent quality of life
Time frame: 18 months
Adherence
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Loddenkemper, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Status Epilepticus, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timeliness of AED administration (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.