Seizure Rescue Medication: Caregiver Education in a Simulation Setting

Study Overview
=================
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.

Official Title
-----------------
Seizure Rescue Medication: Caregiver Education in a Simulation Setting

Conditions
-----------------
Status Epilepticus

Intervention / Treatment
-----------------
* Other: Verbal Instructions Educational Intervention
* Other: Video Educational Intervention
* Other: Mannequin Educational Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

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 |