Relevance of the Self-assessment of Skills for Self-administration of Adrenaline by Auto-injectors in Patients at Risk of Severe Anaphylactic Reaction (PacAdré)
- Conditions
- Severe Anaphylactic Reaction, Self-administration, Adrenaline, Self-assessment
- Registration Number
- NCT05404165
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
To investigate the correlation between self-assessment by patients and an assessment by a health professional of the skills needed for self administration of adrenaline by auto-injectors. These skills include the identification of situations requiring the administration of adrenaline and the technical abilities to achieve it.
Hypothesis:
A self-assessment correlated with an external assessment would make it easier to adjust the frequency of therapeutic education sessions based on the patient's self-assessment alone.
- Detailed Description
Intramuscular Adrenaline is the standard treatment for severe to moderate anaphylaxis. Self-administration of Adrenaline by the patient using an auto-injector pen in case of anaphylaxis is a major axis of management of patients with severe food allergy, hymenoptera venom allergy or systemic mastocytosis. This self-administration skill requires prior therapeutic education of the patient. This education must be repeated over time and must include two components: the identification of anaphylactic situations requiring the self-administration of Adrenalin and the technical skills and abilities to carry out this self-injection.
Numerous studies have investigated the technical skills for using Adrenaline auto-injector pens according to the device prescribed, the importance of therapeutic education, the optimal frequency of therapeutic education sessions for self-administration and the main barriers to the use of Adrenaline.
To our knowledge, no study has investigated the correlation between patients' self-assessment of the skills required for self-administration of Adrenaline by self-injecting pen and an external assessment of these same skills by a health professional.
A self-assessment correlated with an external assessment would make it easier to adjust the frequency of therapeutic education sessions based on patient self-assessment alone.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 56
-
Adult patient
-
Follow-up at the CHU Grenoble Alpes or at the CH Métropole Savoie with at least one consultation every 2 years
-
With a pathology at risk of severe anaphylaxis:
- Severe food allergy and/or,
- Allergy to wasp venom and/or
- Systemic mastocytosis
-
With a current adrenaline prescription that is more than a year old
- Patient with a pathology at risk of severe anaphylaxis not identified in the inclusion criteria (isolated drug allergy, idiopathic anaphylaxis, etc.)
- Patient with cognitive or memory disorders
- Patient not speaking French or with a limited understanding of the language
- Patient not affiliated to a social security scheme
- Refusal of the patient to participate in the research or inability of the patient to give his consent
- Patient under guardianship or subject deprived of liberty
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between a patient self-assessment and a health care professional's assessment of the skills needed to self-administer epinephrine by self-injecting pen One day A two-part, 20-point self-assessment scale:
* A visual analog scale addressing skills in identifying situations requiring administration of self-injectable epinephrine, scored out of 10 points
* A visual analogue scale for technical skills in administering epinephrine by self-injecting pen, scored out of 10 points
A two-part health professional assessment scale scored out of 20 points:
* A single response questionnaire asked to the patient including 5 standardized clinical situations, validated by an expert committee, requiring or not the administration of Adrenalin, scored out of 10 points
* An evaluation of the technical skills of injecting adrenaline with a self-injecting pen with a demonstration pen, in 6 steps, scored out of 10 points
- Secondary Outcome Measures
Name Time Method Correlation between patient self-assessment and healthcare professional assessment of ability to identify situations requiring administration of self-injectable epinephrine One day A 10-point self-assessment scale in the form of a visual analogue scale on the ability to identify situations requiring the administration of self-injectable epinephrine and a hetero-assessment with a 10-point single-answer questionnaire including 5 standardized clinical situations, validated by an expert committee, requiring or not the administration of adrenaline
Correlation between a patient's self-assessment and a healthcare professional's assessment of technical skills in performing epinephrine administration by self-injecting pen One day A 10-point self-assessment scale in the form of a visual analog scale of technical skills in performing epinephrine administration by self-injecting pen and a 10-point hetero-assessment of epinephrine injection skills by self-injecting pen with a 6-step demonstration pen.