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Seizure Rescue Medication: Caregiver Education in a Simulation Setting

Primary Purpose

Status Epilepticus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verbal Instructions Educational Intervention
Video Educational Intervention
Mannequin Educational Intervention
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Status Epilepticus

Eligibility Criteria

2 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Adult caregivers of patients with epilepsy followed at BCH with the following:

    1. At least one seizure >5 minutes
    2. Prescription for rectal diazepam rescue medication
    3. Admission for seizure/neurologic problem or neurology/epilepsy clinic visit during the enrollment period
  2. Adult caregivers of patients without epilepsy

Exclusion Criteria:

  1. Adult caregivers of epilepsy patients without a rectal diazepam prescription
  2. Non-English-speaking caregivers

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Verbal Instructions on use of RM

Video on use of RM

Mannequin on use of RM

Arm Description

Caregivers will undergo an educational intervention with typical training with verbal instructions and use of a rectal diazepam trainer.

Caregivers will undergo an educational intervention with training by watching an instructional video regarding rescue medication administration

Caregivers will undergo an educational intervention with training by use of a mannequin to practice administering the rescue medication

Outcomes

Primary Outcome Measures

Change in Time to RM Administration
As determined by time to administer RM to mannequin

Secondary Outcome Measures

Change in "RM Score"
"RM Score" ("Rescue Medication Score") assessing caregivers' ability to administer RM with proper technique before/after training. This score will determine if caregivers were able to independently give the medication or if they required a prompt at any step. There is no maximum score, but 1 point will be given for every required prompt such that 0 is a perfect score and higher scores reflect requiring more prompts to administer the medication.
Change in Caregiver Level of Knowledge of Medication Name
Caregiver will be asked to provide medication name on a questionnaire.
Change in Caregiver Level of Knowledge of When to Give Medication
Caregiver will be asked to provide time at which medication is to be given on a questionnaire.
Change in Caregiver Level of Knowledge of Route of Medication Administration
Caregiver will be asked to provide route of medication administration on a questionnaire.
Change in Caregiver Level of Knowledge of Medication Side Effects
Caregiver will be asked to provide medication side effects on a questionnaire.
Change in Caregiver Level of Comfort
Caregiver level of comfort with administration as determined by the pre- and post-questionnaires. Caregivers will report level of comfort before and after training based on a 4-point scale (very uncomfortable, somewhat uncomfortable, somewhat comfortable, very comfortable)
Change in Caregiver Feeling of Ease with Administration
Caregiver level of ease with administration as determined by the pre- and post-questionnaires. Caregivers will fill out the short-form State-Trait Anxiety Inventory (STAI-6) on a 4-point scale (not at all, somewhat, moderately, very much)

Full Information

First Posted
March 6, 2018
Last Updated
September 2, 2020
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03562351
Brief Title
Seizure Rescue Medication: Caregiver Education in a Simulation Setting
Official Title
Seizure Rescue Medication: Caregiver Education in a Simulation Setting
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
September 17, 2019 (Actual)
Study Completion Date
September 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
1. Design an educational quality improvement program to assess the most effective educational approach on caregiver seizure RM application. The investigators hypothesize that this educational program will improve caregiver comfort, knowledge of emergent seizure care, and time to medication application. Specifically, the aims include: Create an educational video reviewing RM administration Develop and validate a simulation training model/mannequin for rectal diazepam administration Expand training to other seizure RMs (e.g. intranasal midazolam, buccal lorazepam) and transition the most effective educational model back to the clinics/bedside to standardize caregiver teaching throughout the department/hospital
Detailed Description
The investigators will implement an intervention jointly with a simulation program to determine the most effective training model: verbal instructions, instructional video, or use of a mannequin. Caregivers will undergo a training curriculum, and 60 caregivers (20 assigned to each educational model) will be matched into three groups and assigned to participate in one of three educational models in the SIM Center. Pre-and post-training questionnaires will be distributed to assess provider knowledge and comfort level. Scoring of caregiver technique administering rectal diazepam to a mannequin and time to RM administration will be obtained to compare between the three educational arms of the study. Thirty additional patients (10 per group) will not receive an assessment of caregiver technique administering RM to the mannequin prior to the educational intervention to control for exposure to the mannequin. Ultimately, the most effective educational method in this simulation pilot study will be expanded to other RM types (e.g. intranasal midazolam, buccal lorazepam), standardized, and brought back to the clinics/bedside throughout the hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Epilepticus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators will implement an intervention jointly with our simulation program to determine the most effective training model: verbal instructions, instructional video, or use of a mannequin. Caregivers will undergo a training curriculum, and 90 caregivers (30 assigned to each educational model) will be matched into three groups and assigned to participate in one of three educational models in the SIM Center.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verbal Instructions on use of RM
Arm Type
Experimental
Arm Description
Caregivers will undergo an educational intervention with typical training with verbal instructions and use of a rectal diazepam trainer.
Arm Title
Video on use of RM
Arm Type
Experimental
Arm Description
Caregivers will undergo an educational intervention with training by watching an instructional video regarding rescue medication administration
Arm Title
Mannequin on use of RM
Arm Type
Experimental
Arm Description
Caregivers will undergo an educational intervention with training by use of a mannequin to practice administering the rescue medication
Intervention Type
Other
Intervention Name(s)
Verbal Instructions Educational Intervention
Intervention Description
Caregivers will undergo training with verbal instructions
Intervention Type
Other
Intervention Name(s)
Video Educational Intervention
Intervention Description
Caregivers will undergo training with an educational video
Intervention Type
Other
Intervention Name(s)
Mannequin Educational Intervention
Intervention Description
Caregivers will undergo training with a mannequin
Primary Outcome Measure Information:
Title
Change in Time to RM Administration
Description
As determined by time to administer RM to mannequin
Time Frame
Baseline and 30 minutes post-intervention
Secondary Outcome Measure Information:
Title
Change in "RM Score"
Description
"RM Score" ("Rescue Medication Score") assessing caregivers' ability to administer RM with proper technique before/after training. This score will determine if caregivers were able to independently give the medication or if they required a prompt at any step. There is no maximum score, but 1 point will be given for every required prompt such that 0 is a perfect score and higher scores reflect requiring more prompts to administer the medication.
Time Frame
Baseline and 30 minutes post-intervention
Title
Change in Caregiver Level of Knowledge of Medication Name
Description
Caregiver will be asked to provide medication name on a questionnaire.
Time Frame
Baseline and 30 minutes post-intervention
Title
Change in Caregiver Level of Knowledge of When to Give Medication
Description
Caregiver will be asked to provide time at which medication is to be given on a questionnaire.
Time Frame
Baseline and 30 minutes post-intervention
Title
Change in Caregiver Level of Knowledge of Route of Medication Administration
Description
Caregiver will be asked to provide route of medication administration on a questionnaire.
Time Frame
Baseline and 30 minutes post-intervention
Title
Change in Caregiver Level of Knowledge of Medication Side Effects
Description
Caregiver will be asked to provide medication side effects on a questionnaire.
Time Frame
Baseline and 30 minutes post-intervention
Title
Change in Caregiver Level of Comfort
Description
Caregiver level of comfort with administration as determined by the pre- and post-questionnaires. Caregivers will report level of comfort before and after training based on a 4-point scale (very uncomfortable, somewhat uncomfortable, somewhat comfortable, very comfortable)
Time Frame
Baseline and 30 minutes post-intervention
Title
Change in Caregiver Feeling of Ease with Administration
Description
Caregiver level of ease with administration as determined by the pre- and post-questionnaires. Caregivers will fill out the short-form State-Trait Anxiety Inventory (STAI-6) on a 4-point scale (not at all, somewhat, moderately, very much)
Time Frame
Baseline and 30 minutes post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult caregivers of patients with epilepsy followed at BCH with the following: At least one seizure >5 minutes Prescription for rectal diazepam rescue medication Admission for seizure/neurologic problem or neurology/epilepsy clinic visit during the enrollment period Adult caregivers of patients without epilepsy Exclusion Criteria: Adult caregivers of epilepsy patients without a rectal diazepam prescription Non-English-speaking caregivers
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Seizure Rescue Medication: Caregiver Education in a Simulation Setting

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