Seizure Rescue Medication: Caregiver Education in a Simulation Setting

Sponsor
Boston Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03562351
Collaborator
(none)
17
1
3
14.6
1.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Verbal Instructions Educational Intervention
  • Other: Video Educational Intervention
  • Other: Mannequin Educational Intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Seizure Rescue Medication: Caregiver Education in a Simulation Setting
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Sep 17, 2019
Actual Study Completion Date :
Sep 17, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Verbal Instructions Educational Intervention
Caregivers will undergo training with verbal instructions

Experimental: Video on use of RM

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

Other: Video Educational Intervention
Caregivers will undergo training with an educational video

Experimental: Mannequin on use of RM

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

Other: Mannequin Educational Intervention
Caregivers will undergo training with a mannequin

Outcome Measures

Primary Outcome Measures

  1. Change in Time to RM Administration [Baseline and 30 minutes post-intervention]

    As determined by time to administer RM to mannequin

Secondary Outcome Measures

  1. Change in "RM Score" [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 [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 [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 [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 [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 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Adult caregivers of patients with epilepsy followed at BCH with the following:

  2. At least one seizure >5 minutes

  3. Prescription for rectal diazepam rescue medication

  4. Admission for seizure/neurologic problem or neurology/epilepsy clinic visit during the enrollment period

  5. Adult caregivers of patients without epilepsy

Exclusion Criteria:
  1. Adult caregivers of epilepsy patients without a rectal diazepam prescription

  2. Non-English-speaking caregivers

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston Children's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Boston Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tobias Loddenkemper, Associate Professor, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT03562351
Other Study ID Numbers:
  • P00027241
First Posted:
Jun 19, 2018
Last Update Posted:
Sep 4, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 4, 2020