跳至主要内容
临床试验/NCT03562351
NCT03562351已完成不适用

Seizure Rescue Medication: Caregiver Education in a Simulation Setting

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Change in Time to RM Administration

研究概览

简要总结

  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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Change in Time to RM Administration

时间窗: Baseline and 30 minutes post-intervention

As determined by time to administer RM to mannequin

次要结局

  • Change in "RM Score"(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 Comfort(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 Name(Baseline and 30 minutes post-intervention)
  • Change in Caregiver Level of Knowledge of Medication Side Effects(Baseline and 30 minutes post-intervention)
  • Change in Caregiver Feeling of Ease with Administration(Baseline and 30 minutes post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tobias Loddenkemper

Associate Professor

Boston Children's Hospital

研究点 (2)

Loading locations...

相似试验