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Seizure Rescue Medication: Caregiver Education in a Simulation Setting

Seizure Rescue Medication: Caregiver Education in a Simulation Setting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03562351
Enrollment
17
Registered
2018-06-19
Start date
2018-07-01
Completion date
2019-09-17
Last updated
2020-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Status Epilepticus

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: 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

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.

Interventions

OTHERVerbal Instructions Educational Intervention

Caregivers will undergo training with verbal instructions

OTHERVideo Educational Intervention

Caregivers will undergo training with an educational video

OTHERMannequin Educational Intervention

Caregivers will undergo training with a mannequin

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
2 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Time to RM AdministrationBaseline and 30 minutes post-interventionAs determined by time to administer RM to mannequin

Secondary

MeasureTime frameDescription
Change in Caregiver Level of Knowledge of Medication NameBaseline and 30 minutes post-interventionCaregiver will be asked to provide medication name on a questionnaire.
Change in Caregiver Level of Knowledge of When to Give MedicationBaseline and 30 minutes post-interventionCaregiver 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 AdministrationBaseline and 30 minutes post-interventionCaregiver will be asked to provide route of medication administration on a questionnaire.
Change in RM ScoreBaseline and 30 minutes post-interventionRM 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 ComfortBaseline and 30 minutes post-interventionCaregiver 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 AdministrationBaseline and 30 minutes post-interventionCaregiver 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)
Change in Caregiver Level of Knowledge of Medication Side EffectsBaseline and 30 minutes post-interventionCaregiver will be asked to provide medication side effects on a questionnaire.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026