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Completed

NCT Number: NCT03562351

Seizure Rescue Medication: Caregiver Education in a Simulation Setting

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

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Key information

Conditions

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

Age range

2 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Verbal Instructions Educational Intervention

Other

Caregivers will undergo training with verbal instructions

Video Educational Intervention

Other

Caregivers will undergo training with an educational video

Mannequin Educational Intervention

Other

Caregivers will undergo training with a mannequin

Primary outcomes

  1. Change in Time to RM Administration

    Time frame: Baseline and 30 minutes post-intervention

    As determined by time to administer RM to mannequin

Secondary outcomes

  1. Change in "RM Score"

    Time frame: Baseline and 30 minutes post-intervention

    "RM 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.

  2. Change in Caregiver Level of Knowledge of Medication Name

    Time frame: Baseline and 30 minutes post-intervention

    Caregiver will be asked to provide medication name on a questionnaire.

  3. Change in Caregiver Level of Knowledge of When to Give Medication

    Time frame: Baseline and 30 minutes post-intervention

    Caregiver will be asked to provide time at which medication is to be given on a questionnaire.

  4. Change in Caregiver Level of Knowledge of Route of Medication Administration

    Time frame: Baseline and 30 minutes post-intervention

    Caregiver will be asked to provide route of medication administration on a questionnaire.

  5. Change in Caregiver Level of Knowledge of Medication Side Effects

    Time frame: Baseline and 30 minutes post-intervention

    Caregiver will be asked to provide medication side effects on a questionnaire.

  6. Change in Caregiver Level of Comfort

    Time frame: Baseline and 30 minutes post-intervention

    Caregiver 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)

  7. Change in Caregiver Feeling of Ease with Administration

    Time frame: Baseline and 30 minutes post-intervention

    Caregiver 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)

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2018
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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