Seizure Rescue Medication: Caregiver Education in a Simulation Setting

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:

1. Create an educational video reviewing RM administration
2. Develop and validate a simulation training model/mannequin for rectal diazepam administration
3. 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

Study Overview

• Status: Completed
• Conditions: Status Epilepticus
• Intervention / Treatment: Other: Verbal Instructions Educational Intervention; Other: Video Educational Intervention; Other: Mannequin Educational Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

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: 2 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Verbal Instructions on use of RM; Caregivers will undergo an educational intervention with typical training with verbal instructions and use of a rectal diazepam trainer.	Other: Verbal Instructions Educational Intervention; Caregivers will undergo training with verbal instructions
EXPERIMENTAL: Video on use of RM; Caregivers will undergo an educational intervention with training by watching an instructional video regarding rescue medication administration	Other: Video Educational Intervention; Caregivers will undergo training with an educational video
EXPERIMENTAL: Mannequin on use of RM; Caregivers will undergo an educational intervention with training by use of a mannequin to practice administering the rescue medication	Other: Mannequin Educational Intervention; Caregivers will undergo training with a mannequin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Time to RM Administration	As determined by time to administer RM to mannequin	Baseline and 30 minutes post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 30 minutes post-intervention
Change in Caregiver Level of Knowledge of Medication Name	Caregiver will be asked to provide medication name on a questionnaire.	Baseline and 30 minutes post-intervention
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.	Baseline and 30 minutes post-intervention
Change in Caregiver Level of Knowledge of Route of Medication Administration	Caregiver will be asked to provide route of medication administration on a questionnaire.	Baseline and 30 minutes post-intervention
Change in Caregiver Level of Knowledge of Medication Side Effects	Caregiver will be asked to provide medication side effects on a questionnaire.	Baseline and 30 minutes post-intervention
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)	Baseline and 30 minutes post-intervention
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)	Baseline and 30 minutes post-intervention

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2018
• Primary Completion (ACTUAL): September 17, 2019
• Study Completion (ACTUAL): September 17, 2019

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (ACTUAL): June 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Status Epilepticus
• Other Study ID Numbers: P00027241

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No