Underreporting of Occupational Blood Exposure (OBE) Among Medical Staff at an University Hospital Center (UHC) in 2017 (OBE PRACTITIONERS UHC 2017)

May 28, 2018 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1493

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand
      • La Tronche, France, 38700
        • Chu Grenoble Alpes
      • Pierre-Bénite, France, 69495
        • Groupement Hospitalier Sud
      • Saint-Étienne, France, 42055
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

University Hospital Center (UHC) Medical staff

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The occurrence circumstances of OBE
Time Frame: 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
The part of each factor, related to the professional activity and to the OBE itself, in the OBE reporting.
Time Frame: 1 day

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
Time Frame: 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
Practitioners knowledges about the specific infectious risk of OBE
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL17_0883

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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