- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03424434
Underreporting of Occupational Blood Exposure (OBE) Among Medical Staff at an University Hospital Center (UHC) in 2017 (OBE PRACTITIONERS UHC 2017)
Underreporting of Occupational Blood Exposure (OBE) Among Medical Staff at an University Hospital Center (UHC) in 2017
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
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Clermont-Ferrand, France, 63003
- Chu Clermont-Ferrand
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La Tronche, France, 38700
- Chu Grenoble Alpes
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Pierre-Bénite, France, 69495
- Groupement Hospitalier Sud
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Saint-Étienne, France, 42055
- Chu de Saint-Etienne
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Any medical or surgical health professional
- practitioner and resident
- working in an UHC
- without distinction of medical or surgical specialty
- having a professional mailbox
Exclusion Criteria:
- All paramedical health professionals (example: nurses) and pharmacists
- Any medical or surgical health professional working full-time outside an UHC
- Any medical or surgical health professional with exclusive liberal activity outside an UHC
- Administrative and technical staff of an UHC
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Medical staff of an UHC, practitioners and residents
The target population is practitioners and residents who works at hospital in an UHC, they are also specialists, surgeons, dental surgeons.
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The study consists in a survey diffusion during several weeks by emailing each practitioner and resident and inviting them to participate to a questionnaire about occupational blood exposure.
This survey is strictly anonymous.
No identity data is required, only age, gender, function, surgical or medical specialty, work quota and hospital group they belong.
This survey is diffused in four UHC (Lyon, Grenoble, Clermont-Ferrand and Saint-Etienne) in France.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Evaluation of underreporting occupational blood exposure (OBE) among the medical staff at an University Hospital Center (UHC) for the year 2017
Délai: 1 day
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This evaluation consists in collecting, during the diffusion of a survey, the number of OBE the medical professional is victim of and the number of OBE is reported to deduce the number of non-reported OBE, over the period of interest which is the year 2017.
|
1 day
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The occurrence circumstances of OBE
Délai: 1 day
|
These questions are gathered in a table and concern different sorts of contaminated needlesticks, blood projections, cut or wound and the positive serologic status for the source patient. This specific outcome is qualitatively evaluated with questions relating to the occurence circumstances of OBE with a choice of standards answers (Yes, always - Often - Sometimes - No, never). |
1 day
|
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The part of each factor, related to the professional activity and to the OBE itself, in the OBE reporting.
Délai: 1 day
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Some questions are gathered in a table and propose 15 differents reasons that can condition the OBE reporting, such as lack of time, fear of judgment, repetition of OBE, unknowing of reporting procedure, lack of standards precautions, only antisepsis maneuvers sufficient, source patient considered as safe, procedure to report considered complex, fear of career consequences, lack of witness, night work, negatives serologies for the source patient, fear of the serological follow-up, fear observing an antiretroviral treatment, ignorance that an OBE was a true one. For each factor, a percentage will be measured as indicative of its importance in the OBE underreporting. This specific outcome considering various factors that can influence the reporting of an OBE is evaluated by several questions with a yes or no answer. |
1 day
|
|
Involvement of behaviors of underreporting medical professionals
Délai: 1 day
|
Using two tables, several measures recommanded about the biological risk in hospital environment (including OBE) are discussed. These differents measures are considered as primary and secondary preventive behaviors. For each measure, we examine its frequency as indicative of its implication in the OBE underreporting. This outcome is evaluated with questions on vaccination, immunization, wearing of personal protective equipment and realization of the antisepsis maneuvers, realization of serologies for source patient and personal ones, with a choice of standards answers (Yes, always - Often - Sometimes - No, never). |
1 day
|
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Practitioners knowledges about the specific infectious risk of OBE
Délai: 1 day
|
On a first table, the participant has to choose one of the four rates proposed (30% - 1 to 3% - 0,3% - < 0,3%) to evaluate the risk of seroconversion after percutaneous contact with infected blood by HIV or hepatitis B virus (HBV) or hepatitis C virus (HCV). On a second table, the participant has to choose a time limit (Immediately - within 4 hours - within 48 hours - up to 7 days) for different situations near OBE occurence, it concerns antisepsis maneuvers, prophylactic antiretroviral treatment, initial personal serological status and source patient serological status. A test is proposed to evaluate knowledges about the infectious risk related to OBE, this test is optional, grouping together seven simple choice questions. |
1 day
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 69HCL17_0883
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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