Knowledge, Perception and Behaviour of Resistance to Antimicrobial Among HCWPerceptRNCT02265471
Knowledge and Perception of Resistance to Antimicrobials Among Healthcare Workers in France
An observational study of Knowledge, Perception and Behaviour of Resistance to Antimicrobial Among HCW, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objectives of this survey are to determine the level of antimicrobial resistance knowledge and perception of health care workers (HCW) in France, to measure the impact of health care facilities (HCF) and to identify the drivers and barriers to change. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Perception and Behaviour of Resistance to Antimicrobial Among HCW
- How many people
- 10,000 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Feb 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: health care workers (medical or not)
Who may be able to join
- doctors, nurses and aides, employed or in training, and directly participating in care
Who cannot join
- physicians not participating in care, pharmacist, laboratory employees, administrative employees
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knowledge and Perception of Resistance to Antimicrobials in French Healthcare Facilities
The objectives of this survey are to determine the level of antimicrobial resistance knowledge and perception of health care workers (HCW) in France, to measure the impact of health care facilities (HCF) and to identify the drivers and barriers to change. To achieve this goal, a cross-sectional survey on one day with a self-administered questionnaire and semi-structured interviews with HCWs is proposed. This study will be planned in 60 different HCFs randomly selected and expected to include of 2,100 to 10,000 respondents.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| university hospital | university hospital | |
| large or small public hospitals | large or small public hospitals | |
| private HCFs | private HCFs | |
| referral centers for cancer | referral centers for cancer | |
| chirurgical facilities, clinic | chirurgical facilities, clinic | |
| mixed group | local hospitals, long term care and post-op and rehabilitation facilities, and nursing homes |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of healthcare workers with appropriate knowledge and related environmental conditions
psycho-social-cognitive determinants of knowledge and perceptions and the culture of the organisation
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 posted16 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knowledge, Perception and Behaviour of Resistance to Antimicrobial Among HCWStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Christophe Lucet, PHD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265471
- Sponsor's protocol ID
- PHRQ1277
- Acronym
- PerceptR
- Status last verified
- Apr 2014
- First submitted
- 27 May 2014
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Vaillant L, Birgand G, Esposito-Farese M, Astagneau P, Pulcini C, Robert J, Zahar JR, Sales-Wuillemin E, Tubach F, Lucet JC; PerceptR Study group. Awareness among French healthcare workers of the transmission of multidrug resistant organisms: a large cross-sectional survey. Antimicrob Resist Infect Control. 2019 Nov 12;8:173. doi: 10.1186/s13756-019-0625-0. eCollection 2019.
PubMed 31749961
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Perception of Resistance to Antimicrobials in French Healthcare Facilities
- ClinicalTrials.gov ID
- NCT02265471
- Acronym / sponsor ID
- PerceptR / PHRQ1277
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Oct 2014 (estimated)
- 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.
The objectives of this survey are to determine the level of antimicrobial resistance knowledge and perception of health care workers (HCW) in France, to measure the impact of health care facilities (HCF) and to identify the drivers and barriers to change. To achieve this goal, a cross-sectional survey on one day with a self-administered questionnaire and semi-structured interviews with HCWs is proposed. This study will be planned in 60 different HCFs randomly selected and expected to include of 2,100 to 10,000 respondents.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| university hospital | – | –university hospital |
| large or small public hospitals | – | –large or small public hospitals |
| private HCFs | – | –private HCFs |
| referral centers for cancer | – | –referral centers for cancer |
| chirurgical facilities, clinic | – | –chirurgical facilities, clinic |
| mixed group | – | –local hospitals, long term care and post-op and rehabilitation facilities, and nursing homes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- health care workers (medical or not)
Key inclusion criteria (1 listed)
- doctors, nurses and aides, employed or in training, and directly participating in care
Key exclusion criteria (1 listed)
- physicians not participating in care, pharmacist, laboratory employees, administrative employees
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
percentage of healthcare workers with appropriate knowledge and related environmental conditions
Time frame: 1 day
psycho-social-cognitive determinants of knowledge and perceptions and the culture of the organisation
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 23 Jul 2018.
- Derived from this study: PubMed 31749961Vaillant L, Birgand G, Esposito-Farese M, Astagneau P, Pulcini C, Robert J, Zahar JR, Sales-Wuillemin E, Tubach F, Lucet JC; PerceptR Study group. Awareness among French healthcare workers of the transmission of multidrug resistant organisms: a large cross-sectional survey. Antimicrob Resist Infect Control. 2019 Nov 12;8:173. doi: 10.1186/s13756-019-0625-0. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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.
Jean Christophe Lucet, PHD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knowledge, Perception and Behaviour of Resistance to Antimicrobial Among HCW, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 1 inclusion and 1 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 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
percentage of healthcare workers with appropriate knowledge and related environmental conditions (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02265471, which also lists 1 linked publication.
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 23 Jul 2018.