Seizure Rescue Medication: Caregiver Education in a Simulation Setting

Status Epilepticus Clinical Trial

Official title:

Seizure Rescue Medication: Caregiver Education in a Simulation Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03562351
• Other study ID #: P00027241
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: September 17, 2019

Study information

• Verified date: September 2020
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Seizures
• Status Epilepticus

Intervention

Other:
• Verbal Instructions Educational Intervention
Caregivers will undergo training with verbal instructions
• Video Educational Intervention
Caregivers will undergo training with an educational video
• Mannequin Educational Intervention
Caregivers will undergo training with a mannequin

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Time to RM Administration	As determined by time to administer RM to mannequin	Baseline and 30 minutes post-intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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