Make up for the Epinephrine Autoinjector

Study Overview
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Brief Summary
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Part of the problems related with proper use of epinephrine autoinjector may be related with the design of the autoinjector itself.The aim of the study is to investigate whether minor modifications in the design of currently available epinephrine autoinjector ease its use and abrogate common use errors.

Detailed Description
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All interns except the ones who previously worked in allergy department in a medical school were invited to the study. Two identical epinephrine autoinjector trainers (Epipen trainer®) were used, one of which was modified by changing gray safety cap to red and placing a yellow arrow pointing to the black injection tip. Written and visual instruction sheet for each trainer was provided. Participants were asked to demonstrate the use of Epipen trainer either with the original or the modified one. They were scored and timed for demonstration. Primary study parameter was the rate of participants correctly demonstrating the use of epinephrine autoinjector. Secondary study parameters were the mean total score, mean time required to administer autoinjector and unintentional self injection of autoinjector into thumb.

Official Title
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Make up for the Epinephrine Autoinjector: Effect on Its Use by Untrained Users

Conditions
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Anaphylaxis

Intervention / Treatment
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* Device: Epinephrine autoinjector


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:We invited all interns in our faculty to inform about the study and included the ones who gave informed consent - Exclusion Criteria:Interns who previously worked in allergy department were excluded. -

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Original epinephrine autoinjector group<br>Participants were given original epinephrine autoinjector trainer wrapped by a gray sticky paper. | Device: Epinephrine autoinjector<br>* We used 2 epinephrine autoinjector trainers and wrapped them by a gray sticky paper. Then,modified one of the trainers by changing gray safety cap to red with an atomizer paint and placing a yellow arrow pointing to the black injection tip.We provided three-step written and visual instruction sheet to use epinephrine autoinjector in Turkish same as given on the original trainer and changed that of the second trainer according to the modifications we made. Scoring system originally devised by Sicherer et al was used. Participants successively doing all steps were accepted to demonstrate autoinjector use correctly. Participants who tackled with black tip of autoinjector in order to eject needle after removing safety cap was regarded as unsuccessful since this may cause unintentional injection of epinephrine. All participants were scored and timed separately.<br>* Other names: Epipen trainer®, Meridian Medical Technologies, Inc. Columbia, USA;|
| Active Comparator: Modified epinephrine autoinjector group<br>Participants were given the same epinephrine autoinjector trainer wrapped by a gray sticky paper which was modified by changing gray safety cap to red with an atomizer paint and placing a yellow arrow pointing to the black injection tip. | Device: Epinephrine autoinjector<br>* We used 2 epinephrine autoinjector trainers and wrapped them by a gray sticky paper. Then,modified one of the trainers by changing gray safety cap to red with an atomizer paint and placing a yellow arrow pointing to the black injection tip.We provided three-step written and visual instruction sheet to use epinephrine autoinjector in Turkish same as given on the original trainer and changed that of the second trainer according to the modifications we made. Scoring system originally devised by Sicherer et al was used. Participants successively doing all steps were accepted to demonstrate autoinjector use correctly. Participants who tackled with black tip of autoinjector in order to eject needle after removing safety cap was regarded as unsuccessful since this may cause unintentional injection of epinephrine. All participants were scored and timed separately.<br>* Other names: Epipen trainer®, Meridian Medical Technologies, Inc. Columbia, USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants correctly demonstrating the use of epinephrine autoinjector. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean total score participants get during demonstration of epinephrine autoinjector use |  |  | 
| Mean time required to administer epinephrine autoinjector |  |  | 
| Unintentional self injection of autoinjector into thumb |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anaphylaxis, autoinjector, design, epinephrine