Seizure Rescue Medication: Caregiver Education in a Simulation Setting

NCT ID: NCT03562351

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-09-17

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.

Conditions

Status Epilepticus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Verbal Instructions on use of RM

Caregivers will undergo an educational intervention with typical training with verbal instructions and use of a rectal diazepam trainer.

Group Type: EXPERIMENTAL

Verbal Instructions Educational Intervention

Intervention Type: OTHER

Caregivers will undergo training with verbal instructions

Video on use of RM

Caregivers will undergo an educational intervention with training by watching an instructional video regarding rescue medication administration

Group Type: EXPERIMENTAL

Video Educational Intervention

Intervention Type: OTHER

Caregivers will undergo training with an educational video

Mannequin on use of RM

Caregivers will undergo an educational intervention with training by use of a mannequin to practice administering the rescue medication

Group Type: EXPERIMENTAL

Mannequin Educational Intervention

Intervention Type: OTHER

Caregivers will undergo training with a mannequin

Interventions

Verbal Instructions Educational Intervention

Caregivers will undergo training with verbal instructions

Intervention Type: OTHER

Video Educational Intervention

Caregivers will undergo training with an educational video

Intervention Type: OTHER

Mannequin Educational Intervention

Caregivers will undergo training with a mannequin

Intervention Type: OTHER

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tobias Loddenkemper

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

P00027241

Identifier Type: -

Identifier Source: org_study_id