Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03424434
Other study ID # 69HCL17_0883
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 13, 2018
Est. completion date May 19, 2018

Study information

Verified date March 2018
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Regarding 30 to 50% of occupational blood exposure (OBE) are underreporting among health professionals, it's to highlight that the part of medical professionals in OBE reporting is among the lowest (1996 to 2016). The current study is aiming to evaluate the underreporting of this specific occupational accident among medical staff for the year 2017. The investigators are supposing this is declining and the part of OBE reporting is better than before. So the current situation concerning OBE underreporting for medical staff in an University Hospital Center (UHC), 20 years after the first study, is our main purpose.


Recruitment information / eligibility

Status Completed
Enrollment 1493
Est. completion date May 19, 2018
Est. primary completion date May 19, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey diffusion
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.

Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand
France CHU Grenoble Alpes La Tronche
France Groupement Hospitalier Sud Pierre-Bénite
France CHU de Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of underreporting occupational blood exposure (OBE) among the medical staff at an University Hospital Center (UHC) for the year 2017 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
Secondary The occurrence circumstances of OBE 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
Secondary The part of each factor, related to the professional activity and to the OBE itself, in the OBE reporting. 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
Secondary Involvement of behaviors of underreporting medical professionals 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
Secondary Practitioners knowledges about the specific infectious risk of OBE 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