Seizure Rescue Medication: Caregiver Education in a Simulation Setting

NCT03562351 | Completed

• 1 other identifier: P00027241
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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. 1.Create an educational video reviewing RM administration
2. 2.Develop and validate a simulation training model/mannequin for rectal diazepam administration
3. 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

Conditions

Status Epilepticus

Outcome Measures

Primary Outcomes (1)

• Change in Time to RM Administration

  As determined by time to administer RM to mannequin

  Baseline and 30 minutes post-intervention

Secondary Outcomes (7)

• Change in "RM Score"

  Baseline and 30 minutes post-intervention

• Change in Caregiver Level of Knowledge of Medication Name

  Baseline and 30 minutes post-intervention

• Change in Caregiver Level of Knowledge of When to Give Medication

  Baseline and 30 minutes post-intervention

• Change in Caregiver Level of Knowledge of Route of Medication Administration

  Baseline and 30 minutes post-intervention

• Change in Caregiver Level of Knowledge of Medication Side Effects

  Baseline and 30 minutes post-intervention

Study Arms (3)

Verbal Instructions on use of RM

EXPERIMENTAL

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

Other: Verbal Instructions Educational Intervention

Video on use of RM

EXPERIMENTAL

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

Other: Video Educational Intervention

Mannequin on use of RM

EXPERIMENTAL

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

Other: Mannequin Educational Intervention

Interventions

Verbal Instructions Educational Intervention OTHER

Caregivers will undergo training with verbal instructions

Verbal Instructions on use of RM

Video Educational Intervention OTHER

Caregivers will undergo training with an educational video

Video on use of RM

Mannequin Educational Intervention OTHER

Caregivers will undergo training with a mannequin

Mannequin on use of RM

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult caregivers of patients with epilepsy followed at BCH with the following:
• At least one seizure \>5 minutes
• Prescription for rectal diazepam rescue medication
• Admission for seizure/neurologic problem or neurology/epilepsy clinic visit during the enrollment period
• Adult caregivers of patients without epilepsy

You may not qualify if:

• Adult caregivers of epilepsy patients without a rectal diazepam prescription
• Non-English-speaking caregivers

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: June 19, 2018
• Study Start: July 1, 2018
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)