Health ProfessionalNCT03424434
Underreporting of Occupational Blood Exposure (OBE) Among Medical Staff at an University Hospital Center (UHC) in 2017 (OBE PRACTITIONERS UHC 2017)
An observational study of Health Professional, run by Hospices Civils de Lyon at 4 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Professional
- What is being tested?
- Survey diffusion
- How many people
- 1,493 participants
- Where
- 4 sitesFrance
- Study dates
- 13 Mar 2018to 19 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: University Hospital Center (UHC) Medical staff
Who may be able to join
- Any medical or surgical health professional
- practitioner and resident
- working in an UHC
- without distinction of medical or surgical specialty
- having a professional mailbox
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
CHU Grenoble Alpes
La Tronche, 38700
Groupement Hospitalier Sud
Pierre-Bénite, 69495
CHU de Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Underreporting of Occupational Blood Exposure (OBE) Among Medical Staff at an University Hospital Center (UHC) in 2017
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.
- Conditions
- Health Professional
- Being tested
- Survey diffusion
- Keywords
- Occupational blood exposure, underreporting, medical, hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey diffusionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Survey diffusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (4)
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).
Measured: 1 day
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.
Measured: 1 day
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).
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start13 Mar 2018
- Primary completion19 May 2018
- Study completion19 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health ProfessionalStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424434
- Sponsor's protocol ID
- 69HCL17_0883
- Status last verified
- Mar 2018
- First submitted
- 23 Jan 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Underreporting of Occupational Blood Exposure (OBE) Among Medical Staff at an University Hospital Center (UHC) in 2017
- ClinicalTrials.gov ID
- NCT03424434
- Acronym / sponsor ID
- 69HCL17_0883
- Conditions
- Health Professional
- Keywords
- Occupational blood exposure, underreporting, medical, hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,493 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 19 May 2018 (actual)
- Study completion
- 19 May 2018 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical staff of an UHC, practitioners and residents | – | Other: Survey diffusionThe target population is practitioners and residents who works at hospital in an UHC, they are also specialists, surgeons, dental surgeons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- University Hospital Center (UHC) Medical staff
Key inclusion criteria (5 listed)
- Any medical or surgical health professional
- practitioner and resident
- working in an UHC
- without distinction of medical or surgical specialty
- having a professional mailbox
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey diffusionThe 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. | Other | Medical staff of an UHC, practitioners and residents |
Primary outcome
Evaluation of underreporting occupational blood exposure (OBE) among the medical staff at an University Hospital Center (UHC) for the year 2017
Time frame: 1 day
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.
4 secondary outcomes
The occurrence circumstances of OBE
Time frame: 1 day
The part of each factor, related to the professional activity and to the OBE itself, in the OBE reporting.
Time frame: 1 day
Involvement of behaviors of underreporting medical professionals
Time frame: 1 day
Practitioners knowledges about the specific infectious risk of OBE
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Professional, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of underreporting occupational blood exposure (OBE) among the medical staff at an University Hospital Center (UHC) for the year 2017 (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.