Clinical trial NCT03562351: Seizure Rescue Medication: Caregiver Education in a Simulation Setting
Official title: Seizure Rescue Medication: Caregiver Education in a Simulation Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Status Epilepticus
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 17
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Time to RM Administration
timeFrame: Baseline and 30 minutes post-intervention
Secondary outcomes:
measure: Change in "RM Score"
timeFrame: Baseline and 30 minutes post-intervention
measure: Change in Caregiver Level of Knowledge of Medication Name
timeFrame: Baseline and 30 minutes post-intervention
measure: Change in Caregiver Level of Knowledge of When to Give Medication
timeFrame: Baseline and 30 minutes post-intervention
measure: Change in Caregiver Level of Knowledge of Route of Medication Administration
timeFrame: Baseline and 30 minutes post-intervention
measure: Change in Caregiver Level of Knowledge of Medication Side Effects
timeFrame: Baseline and 30 minutes post-intervention
measure: Change in Caregiver Level of Comfort
timeFrame: Baseline and 30 minutes post-intervention
measure: Change in Caregiver Feeling of Ease with Administration
timeFrame: Baseline and 30 minutes post-intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References: