<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02995759</url>
  </required_header>
  <id_info>
    <org_study_id>P00017871</org_study_id>
    <nct_id>NCT02995759</nct_id>
  </id_info>
  <brief_title>Creation, Implementation, and Analysis of a Seizure Action Plan</brief_title>
  <official_title>Creation, Implementation, and Analysis of a Seizure Action Plan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Data strongly suggests that aggressive and early treatment of status epilepticus (SE) is&#xD;
      crucial for seizure abortion and prevention of long-term neurologic sequelae. We propose the&#xD;
      creation of a seizure action plan, an intervention aimed to guide daily medication use,&#xD;
      outline pre-hospital seizure first aid and rescue medication use, and direct emergency&#xD;
      personnel in patients' individualized SE medication algorithm, with implementation through&#xD;
      the electronic medical record. We hypothesize that the seizure action plan will promote daily&#xD;
      medication adherence, increase use of home rescue mediation, and improve timeliness of AED&#xD;
      (antiepileptic drug) delivery, length of hospital stay, and ICU admission rate in episodes of&#xD;
      status epilepticus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is the creation, implementation, and analysis of a seizure action&#xD;
      plan, an intervention aimed to guide daily medication use, outline pre-hospital seizure first&#xD;
      aide and rescue medication use, and direct emergency personnel in patients' individualized&#xD;
      status epilepticus medication algorithm, with implementation through the electronic medical&#xD;
      record. After creation of the action plan, the primary neurologist and patient/caregiver will&#xD;
      create a patient-specific plan. The action plan will be reviewed and updated as necessary at&#xD;
      each regularly scheduled primary neurology clinic visit. Two studies will aim at analyzing&#xD;
      the effectiveness of this intervention. A prospective observational cohort study of patient&#xD;
      care process and outcomes 18 months before and 18 months after initiation of seizure action&#xD;
      plan will analyze patients with status epilepticus requiring hospital admission and/or status&#xD;
      epilepticus that occurs during admission at BCH and measure rescue medication prescription&#xD;
      and application patterns, timeliness of medication administration during SE, use of&#xD;
      appropriately dosed AEDs, rate of intubation, significant hypotension, allergic reaction, and&#xD;
      other adverse events, and hospital length of stay and rate of ICU admissions. A second&#xD;
      prospective observational cohort study of patient outcome variables 18 months before and 18&#xD;
      months after initiation of a seizure action plan obtained through parent-reported ICISS&#xD;
      (Integrated Clinical Information Sharing System)/Trivox data, a web-based platform for&#xD;
      tracking symptoms and response to therapy, will measure rescue medication prescription and&#xD;
      application patterns, interval seizure frequency, effect on patient and parent quality of&#xD;
      life, parent knowledge of AED regimen, and parent self-reported medication adherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Timeliness of AED administration</measure>
    <time_frame>18 months</time_frame>
    <description>Time from seizure onset to administration of AED</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Use of home rescue medications</measure>
    <time_frame>18 months</time_frame>
    <description>Frequency of diastat use in status epilepticus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of appropriately dosed AEDs</measure>
    <time_frame>18 months</time_frame>
    <description>Frequency of AEDs dose within 25% of suggested dose by weight/age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seizure frequency</measure>
    <time_frame>18 months</time_frame>
    <description>Parent-reported seizure frequency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Admission Rate</measure>
    <time_frame>18 months</time_frame>
    <description>Admission to Hospital and ICU rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>18 months</time_frame>
    <description>Rate of intubation, allergic reaction, significant hypotension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on patient/parent quality of life</measure>
    <time_frame>18 months</time_frame>
    <description>PedsQL quality of life measure taken by caregiver</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence</measure>
    <time_frame>18 months</time_frame>
    <description>Parent-reported knowledge of AED regimen and adherence</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">288</enrollment>
  <condition>Epilepsy</condition>
  <condition>Status Epilepticus</condition>
  <arm_group>
    <arm_group_label>SE before Seizure Action Plan</arm_group_label>
    <description>450 patients with status epilepticus prior to seizure action plan initiation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SE after Seizure Action Plan</arm_group_label>
    <description>450 patients with status epilepticus after seizure action plan initiation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Seizure Action Plan</intervention_name>
    <description>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.</description>
    <arm_group_label>SE after Seizure Action Plan</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children aged 1 month to 21 years presenting to Boston Children's Hospital (BCH) with&#xD;
        status epilepticus/seizure cluster or who have status epilepticus/seizure cluster during&#xD;
        admission at BCH who require antiepileptic(s) for abortion and hospital admission. Status&#xD;
        epilepticus is defined as a single seizure lasting 5 minutes or longer; a seizure cluster&#xD;
        is defined as 2 or more seizures within 6 hours.&#xD;
&#xD;
        Children aged 1 month to 21 years with known seizure disorder followed at Boston Children's&#xD;
        Hospital or satellite clinic and enrolled in TriVox/ICISS Health [(Integrated Clinical&#xD;
        Information Sharing System), a web-based platform for tracking symptoms and response to&#xD;
        therapy].&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children aged 1 month to 21 years presenting to Boston Children's Hospital (BCH) with&#xD;
             status epilepticus/seizure cluster or who have status epilepticus/seizure cluster&#xD;
             during admission at BCH who require antiepileptic(s) for abortion and hospital&#xD;
             admission. Status epilepticus is defined as a single seizure lasting 5 minutes or&#xD;
             longer; a seizure cluster is defined as 2 or more seizures within 6 hours.&#xD;
&#xD;
          2. Children aged 1 month to 21 years with known seizure disorder followed at Boston&#xD;
             Children's Hospital or satellite clinic and enrolled in TriVox/ICISS Health&#xD;
&#xD;
        Exclusion Criteria: Exclusion criteria include infantile spasms, not requiring AED to&#xD;
        resolve, no hospital admission, invasive EEG monitoring, unclear seizure onset or&#xD;
        medication administration times, episode of nonconvulsive status epilepticus.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tobias Loddenkemper, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Tobias Loddenkemper</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Status Epilepticus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02995759
org study id: P00017871
nct id: NCT02995759
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Timeliness of AED administration
time frame: 18 months
description: Time from seizure onset to administration of AED
measure: Use of home rescue medications
time frame: 18 months
description: Frequency of diastat use in status epilepticus
measure: Use of appropriately dosed AEDs
time frame: 18 months
description: Frequency of AEDs dose within 25% of suggested dose by weight/age
measure: Seizure frequency
time frame: 18 months
description: Parent-reported seizure frequency
measure: Hospital Admission Rate
time frame: 18 months
description: Admission to Hospital and ICU rates
measure: Adverse events
time frame: 18 months
description: Rate of intubation, allergic reaction, significant hypotension
measure: Effect on patient/parent quality of life
time frame: 18 months
description: PedsQL quality of life measure taken by caregiver
measure: Adherence
time frame: 18 months
description: Parent-reported knowledge of AED regimen and adherence
arm group label: SE before Seizure Action Plan
description: 450 patients with status epilepticus prior to seizure action plan initiation
arm group label: SE after Seizure Action Plan
description: 450 patients with status epilepticus after seizure action plan initiation
intervention type: Other
intervention name: Seizure Action Plan
description: 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.
arm group label: SE after Seizure Action Plan
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tobias Loddenkemper, MD
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Tobias Loddenkemper
investigator title: Principal Investigator
mesh term: Seizures
mesh term: Status Epilepticus
sharing ipd: No