- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02265471
Knowledge and Perception of Resistance to Antimicrobials Among Healthcare Workers in France (PerceptR)
Knowledge and Perception of Resistance to Antimicrobials in French Healthcare Facilities
Study Overview
Status
Detailed Description
BACKGROUND The landscape of antibiotic resistance in hospital has dramatically evolved over the past 10 years, with rapid change of multidrug resistant organisms (MDROs), i.e. decreasing rate of methicillin-resistant Staphylococcus aureus (MRSA) and increasing prevalence of Extended-spectrum beta-lactamase (ESBL) - producing Enterobacteriaceae in the community and the hospital, emergence of highly resistant bacteria (HRB) especially vancomycin-resistant enterococci (VRE) and carbapenemase-producing Enterobacteriaceae (CPE) that are most often imported for foreign countries.
Schematically, the control of bacterial resistance is based on the modulation of antibiotics prescription and on the interruption of HRB or MDRO cross-transmission. Many recommendations have recently been issued for the management of patients carrying HRB or MDRO, but their level of knowledge and implementation in health care facilities (HCF) remains unclear.
Knowledge and perception of resistance to antimicrobials in among health care workers (HCW) are influenced by individual and societal determinants, professional environment and personal experience. The willing of improving antimicrobial resistance awareness and changing behaviors requires an accurate overview of the knowledge and perceptions of the HCW within the French health care settings.
OBJECTIVES The main objective is to determine the level of antimicrobial resistance knowledge among HCWs in France.
The secondary objectives are: 1) to determine the antimicrobial resistance perception of HCW in France; 2) to measure the impact of HCF organisation and the perception on the knowledge of HCW; 3) to identify and analyse the drivers and barriers to change.
MATERIALS AND METHODS The methodology used is a cross-sectional survey on one day with a self-administered questionnaire and semi-structured interviews with HCW (doctors, nurses and aides, employed or in training, and directly participating in care). This survey will be implemented in a random sample representative of the French HCFs. The questionnaires include data on HCF and individual data on respondents and evaluations regarding: the knowledge of HCW (landscape of resistance, the role and control of cross-transmission, the role of selective pressure caused by antibiotics), the perception of antimicrobial resistance (using the Health Belief Model), a measure of organization's workplace culture (based on leadership, commitment, team communication and level of stress / chaos). Semi-structured interviews have been planned to complement the assessment.
JUDGING CRITERIA The main criterion is the level of knowledge with binary encoding. The secondary criteria are based on the psycho-social-cognitive determinants of knowledge and perceptions and the culture of the organisation.
INCLUSIONS Six types of HCF (university hospital, large or small public hospitals, private HCFs, referral centers for cancer, and a mixed group of local hospitals, long term care and post-op and rehabilitation facilities, and nursing homes in each of the 5 interregional coordination centers for infection control (CCLIN). All eligible HCWs working during the survey day will be included. A minimum of 2,100 HCW is required to properly estimate the rate of HCW with the minimum core of knowledge (p<0.05). Actually, a larger number of 5,000 to 10,000 participants should be included.
All HCWs, employed or training, working during the day of the survey (day and night) in the selected HCF will be included except the health workers who are not involved in direct care, non-medical staff other than nurses or nursing auxiliary.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75018
- CHU BICHAT-Claude BERNARD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- doctors, nurses and aides, employed or in training, and directly participating in care
Exclusion Criteria:
- physicians not participating in care, pharmacist, laboratory employees, administrative employees
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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university hospital
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large or small public hospitals
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private HCFs
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referral centers for cancer
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chirurgical facilities, clinic
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mixed group
local hospitals, long term care and post-op and rehabilitation facilities, and nursing homes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage of healthcare workers with appropriate knowledge and related environmental conditions
Time Frame: 1 day
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psycho-social-cognitive determinants of knowledge and perceptions and the culture of the organisation
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1 day
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Collaborators and Investigators
Investigators
- Principal Investigator: Jean Christophe Lucet, PHD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PHRQ1277
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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