Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 11:53 PM
Ignite Modification Date: 2025-12-24 @ 11:53 PM
NCT ID: NCT03562351
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.
Study: NCT03562351
Study Brief:
Protocol Section: NCT03562351