Occupational Exposure to BloodSTRIPPSNCT03532321
Stress at Work and Infectious Risk in Patients and Caregivers
An observational study of Occupational Exposure to Blood and Healthcare-associated Related Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In hospitals, the improvement of working conditions is often considered secondarily to patient satisfaction. Previous studies, showing statistically significant relationships, suggested the impact of hospital departments' organization (staff / patient ratio, bed distribution, caregiver's assignment), of the work… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Exposure to Blood, Healthcare-associated Related Infections, Stress
- What is being tested?
- NA : non interventional study
- How many people
- 750 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2018to 1 Mar 2020
- 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: The target population is the medical (doctors, midwives) and paramedical (nurses' aides, registered nurses, specialized nurses and head nurses) staff, working in hospital departments drawn at random among five volunteer hospital centers in Paris, and who will be present at the time of investigator's passage, at a date drawn at random during the inclusion phase.
Who may be able to join
- For hospital departments:
- acute-care departments among medicine (including geriatrics and pediatrics), surgery, gynecology, obstetrics, intensive care, having at least 30 caregivers (medical and paramedical staff) working for the department.
- Non-inclusion criteria for hospital departments:
- departments having low care activity such as the long-term care, follow-up care, and rehabilitation, psychiatric departments
- hospitals departments for which a closure or restructuring is in progress or planned within 15 months of the start of the investigation.
- statutory and contractual caregivers (nursing assistants, registered nurses, doctors or midwives) working at least at 0.5 full-time-equivalent who will be present at the time of inclusion visit, and having expressed their non-opposition to participate in the study.
Show all 9Show fewer
- Non-inclusion criteria for caregivers:
- all interim (temporary) caregivers, medical students or interns or residents, as likely to change the hospital department during the investigation;
- caregivers (medical or paramedical) whose departure is planned within 15 months of the start of the survey (e.g. pregnant women, caregivers whose retirement is imminent, caregivers waiting for reassignment).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance publique - Hôpitaux de Paris
Paris
Pascal ASTAGNEAU, MD, PhD
About this study
In hospitals, the improvement of working conditions is often considered secondarily to patient satisfaction. Previous studies, showing statistically significant relationships, suggested the impact of hospital departments' organization (staff / patient ratio, bed distribution, caregiver's assignment), of the work environment, and the working conditions on the infectious risk at the hospital departments. In addition, organizational hospital constraints and the organization of care could equally have a major impact on the physical and psychological health of care workers (stress, fatigue, job satisfaction). To date, available data suggest that determinants of occupational stress and fatigue are multifactorial.
This research aims to develop an interdisciplinary approach to link two phenomena that are often studied independently while they are closely intertwined: working conditions and infectious risk in hospitals departments. Their main objective is to study the relationship between stress and caregiver fatigue at the work, organizational determinants and infectious risk for patients (healthcare-associated infections: HAIs) and for caregivers (blood exposure accidents: BEAs). The secondary objective is to analyze how the individual characteristics of the staff, the characteristics of their employment, and the overall organization in the hospital departments where they work interact to explain their physical and psychological state of health, on the one hand, and their behavior face to work (absenteeism, turnover and hand hygiene) on the other hand. The ultimate goal of this research is to be able to propose organizational strategies aimed at both reducing the probability of occurrence of healthcare-associated infections and preventing occupational risks for caregivers.
Read the detailed description
STRIPPS is an etiologic, multi-center cohort study in the Ile-de-France region aiming to study better understands the complex relationship between the work organization, the stress ant and the caregiver fatigue and infectious risk in the hospital departments.
It will be conducted in 5 volunteer hospitals, with 7 to 8 hospital departments selected at random in each center and meeting eligibility inclusion criteria. The envisaged recruitment is approximately 20 staff per hospital department, enabling a total of about 150 staff to be included per center, totaling 750 surveyed caregivers.
The five voluntary centers will designate at least one local correspondent or referent among the hygiene team, the human resources (HR) department and the department of medical information system (DMI). The hygiene referent is the privileged correspondent. He will be part of the scientific committee and will help the investigators in the organization of the study within the hospital departments that will be drawn to participate. The HR and DMI referents are appointed to facilitate the collection of anonymous and aggregated data from the HR and PMSI databases planned for the study.
After obtaining regulatory authorizations, the eligible hospital departments of each hospital center will be drawn at random. Prior to the draw, hygiene referents of each hospital will prepare a list with all eligible hospital departments. Hospital departments will be selected using simple random sampling without replacement as follows in each list, the services will be numbered from 1 to n and 8 numbers between 1 and n will be chosen randomly using a computer. It will have a total of 5 lists (one list per hospital center) and 8 randomly selected numbers per list for a total of 40 randomly selected services. Similarly, visit days and survey start schedules will be drawn at random for the passage of an epidemiologist investigator recruited by the coordinating team. Two survey dates, between one Monday and one Friday of each week, and one survey start schedule, will be drawn at random for each work shift in every participating hospital department, during the entire inclusion period. Information meetings with the staff of the selected participating hospital departments and the communication by display will be organized by the investigators. A 15-day period will be left between the last information meeting held in the service and the closest date drawn for the start of the inclusion visits.
Based on a prospective data collection and using a qualitative-quantitative approach this study will provide some elements to better understand the complex relationship between the work organization, the stress and the caregiver fatigue, and infectious risk in the hospital departments (for patients and caregivers). This is an approach that relies on a conceptual model with several hypotheses to test. The conceptual diagram envisaged in our study has been based on the James Reason's model of accident causation. Indeed, it considers a multi-level interrelation of many factors ranging from organizational climate root causes to infectious risk. This equally includes contributory factors related to caregivers themselves, the care team, work environment as well as immediate causes related to care practices. Thus, for example, the infectious risk such as blood exposure accidents (for caregivers) or healthcare-associated infections (for patients) could be explained by several relationships between a wide range of factors: behavioral changes in care workers such as a decreased adherence with infection control measures as hand hygiene, stress and fatigue of caregivers, an excessive workload, a high nurse turnover or their absenteeism, the work schedules, as well as, by individual factors such as, the work experience, age, and the organizational climate as root causes.
In this research the following factors will be taken into account:
- at the organizational level: the type and size of hospital departments (in number of beds and in number of caregivers), the hourly organization of the staff, the number of caregivers by professional category for each shift in 24h;
- at the hospital department level: nurse absenteeism and turnover rates, safety culture, healthcare-associated infections rates, the rate of blood exposure accidents among caregivers, hand hygiene compliance rates;
- at the level of caregivers: age, sex, personal situation, number of young children, occupation, the position held, work experience, work schedules, stress and fatigue levels, blood exposure accidents, excessive work-related commitment, the social support from coworkers and from supervisors, current state of health, absences due to health reasons including absences due to accidents at work or for work-related illness, etc.
- Being tested
- NA : non interventional study
- Keywords
- Stress, occupational risks, hospital organization, longitudinal
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA : non interventional studyOther
NA : non interventional study
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Caregivers in the participating hospital departments : medical (doctors, midwives) and paramedical (nurses' aides, registered nurses, specialized nurses and head nurses) staff, working in hospital departments drawn at random among five volunteer hospital centers in Paris, and who will be present at the time of investigator's passage, at a date drawn at random during the inclusion phase. Receives: Other: NA : non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious risk in the participating hospital departments
Incidence rate of blood exposure accidents (BEA) at t0 in the participating hospital departments.
The BEA rate will be expressed as the report of the number of declared BEAs on the total number of caregivers interviewed during these periods.
Measured: at Day 0
Infectious risk in the participating hospital departments
Incidence rate of blood exposure accidents (BEA) at t1 in the participating hospital departments.
The BEA rate will be expressed as the report of the number of declared BEAs on the total number of caregivers interviewed during these periods.
Measured: at Months 4
Infectious risk in the participating hospital departments
Incidence rate of blood exposure accidents (BEA) at t2 in the participating hospital departments.
The BEA rate will be expressed as the report of the number of declared BEAs on the total number of caregivers interviewed during these periods.
Measured: at Months 8
Infectious risk in the participating hospital departments
Incidence rate of blood exposure accidents (BEA) at t3 in the participating hospital departments.
The BEA rate will be expressed as the report of the number of declared BEAs on the total number of caregivers interviewed during these periods.
Measured: at Months 12
Incidence rate of healthcare-associated infections (HAI)
- The incidence rate of healthcare-associated infections (HAIs) among inpatients in the participating hospitals departments at t0. Data from the Program for Medicalization of Information Systems (PMSI) of each hospital center will be used as data source. The rate will be expressed as the report of the number of HAIs, listed in the PMSI as significant associated diagnosis, on the total number of hospitalized patients.
Measured: at Day 0
Incidence rate of healthcare-associated infections (HAI)
- The incidence rate of healthcare-associated infections (HAIs) among inpatients in the participating hospitals departments at t0
Measured: at Months 4
Incidence rate of healthcare-associated infections (HAI)
- The incidence rate of healthcare-associated infections (HAIs) among inpatients in the participating hospitals departments at t2
Measured: at Months 8
Incidence rate of healthcare-associated infections (HAI)
- The incidence rate of healthcare-associated infections (HAIs) among inpatients in the participating hospitals departments at t3
Measured: at Months 12
Secondary outcomes (24)
Stress level of caregivers
Stress level of caregivers surveyed in the participating hospital departments measured by validated scales (PSS-10 scale). The French version of the 10-item perceived stress scale scoring (PSS-10) will be used to measure the stress at the individual level. Scores ranging from 27 to 40 on the PSS-10 will be considered as high stress levels.
Measured: at Day 0
Stress level of caregivers
Stress level of caregivers surveyed in the participating hospital departments measured by validated scales (PSS-10 scale). The French version of the 10-item perceived stress scale scoring (PSS-10) will be used to measure the stress at the individual level. Scores ranging from 27 to 40 on the PSS-10 will be considered as high stress levels.
Measured: at Months 4
Stress level of caregivers
Stress level of caregivers surveyed in the participating hospital departments measured by validated scales (PSS-10 scale). The French version of the 10-item perceived stress scale scoring (PSS-10) will be used to measure the stress at the individual level. Scores ranging from 27 to 40 on the PSS-10 will be considered as high stress levels.
Measured: at Months 8
Stress level of caregivers
Stress level of caregivers surveyed in the participating hospital departments measured by validated scales (PSS-10 scale). The French version of the 10-item perceived stress scale scoring (PSS-10) will be used to measure the stress at the individual level. Scores ranging from 27 to 40 on the PSS-10 will be considered as high stress levels.
Measured: at Months 12
Fatigue level of caregivers
Fatigue level of caregivers surveyed in the participating hospital departments measured by validated Pichot fatigue questionnaire. The Pichot fatigue questionnaire will be used to measure it at the individual level. Scores ranging from 22 to 32 on the Pichot fatigue questionnaire will be considered as high fatigue levels.
Measured: at Day 0
Fatigue level of caregivers
Fatigue level of caregivers surveyed in the participating hospital departments measured by validated Pichot fatigue questionnaire. The Pichot fatigue questionnaire will be used to measure it at the individual level. Scores ranging from 22 to 32 on the Pichot fatigue questionnaire will be considered as high fatigue levels.
Measured: at Months 4
Fatigue level of caregivers
Fatigue level of caregivers surveyed in the participating hospital departments measured by validated Pichot fatigue questionnaire. The Pichot fatigue questionnaire will be used to measure it at the individual level. Scores ranging from 22 to 32 on the Pichot fatigue questionnaire will be considered as high fatigue levels.
Measured: at Months 8
Fatigue level of caregivers
Fatigue level of caregivers surveyed in the participating hospital departments measured by validated Pichot fatigue questionnaire. The Pichot fatigue questionnaire will be used to measure it at the individual level. Scores ranging from 22 to 32 on the Pichot fatigue questionnaire will be considered as high fatigue levels.
Measured: at Months 12
Hand hygiene compliance rate in the participating hospital departments, measured via the GREPHH quick-audit system
It will be measured as the number of hand hygiene observation divided by the total number of hand hygiene opportunities according to the GREPHH's quick-audit system. The quick-audits will be carried out in each participating hospital department with the cooperation of the hygiene team of each center, on a given day chosen at random.
Measured: at Day 0
Hand hygiene compliance rate in the participating hospital departments, measured via the GREPHH quick-audit system
It will be measured as the number of hand hygiene observation divided by the total number of hand hygiene opportunities according to the GREPHH's quick-audit system. The quick-audits will be carried out in each participating hospital department with the cooperation of the hygiene team of each center, on a given day chosen at random.
Measured: at Months 4
Hand hygiene compliance rate in the participating hospital departments, measured via the GREPHH quick-audit system
It will be measured as the number of hand hygiene observation divided by the total number of hand hygiene opportunities according to the GREPHH's quick-audit system. The quick-audits will be carried out in each participating hospital department with the cooperation of the hygiene team of each center, on a given day chosen at random.
Measured: at Months 8
Hand hygiene compliance rate in the participating hospital departments, measured via the GREPHH quick-audit system
It will be measured as the number of hand hygiene observation divided by the total number of hand hygiene opportunities according to the GREPHH's quick-audit system. The quick-audits will be carried out in each participating hospital department with the cooperation of the hygiene team of each center, on a given day chosen at random.
Measured: at Months 12
Caregiver absenteeism rate in the participating hospital departments (absences due to health reasons including absences due to accidents at work or for work-related illness), measured on the basis of human resources data
The caregiver absenteeism rate in the participating hospital departments (absences due to health reasons including absences due to accidents at work or for work-related illness), measured on the basis of human resources data, at t0, t1 (t0 + 4 month), t2 (t0 + 8 month), t3 ((t0 + 12 month). It will be expressed as the percentage of the overall days (or hours) that a member of staff could have worked, had they not been absent.
Measured: at Day 0
Caregiver absenteeism rate in the participating hospital departments (absences due to health reasons including absences due to accidents at work or for work-related illness), measured on the basis of human resources data
The caregiver absenteeism rate in the participating hospital departments (absences due to health reasons including absences due to accidents at work or for work-related illness), measured on the basis of human resources data, at t0, t1 (t0 + 4 month), t2 (t0 + 8 month), t3 ((t0 + 12 month). It will be expressed as the percentage of the overall days (or hours) that a member of staff could have worked, had they not been absent.
Measured: at Months 4
Caregiver absenteeism rate in the participating hospital departments (absences due to health reasons including absences due to accidents at work or for work-related illness), measured on the basis of human resources data
The caregiver absenteeism rate in the participating hospital departments (absences due to health reasons including absences due to accidents at work or for work-related illness), measured on the basis of human resources data, at t0, t1 (t0 + 4 month), t2 (t0 + 8 month), t3 ((t0 + 12 month). It will be expressed as the percentage of the overall days (or hours) that a member of staff could have worked, had they not been absent.
Measured: at Months 8
Caregiver absenteeism rate in the participating hospital departments (absences due to health reasons including absences due to accidents at work or for work-related illness), measured on the basis of human resources data
The caregiver absenteeism rate in the participating hospital departments (absences due to health reasons including absences due to accidents at work or for work-related illness), measured on the basis of human resources data, at t3.
Measured: at Months 12
Caregiver turnover rate in the participating hospitals departments, measured on the basis of human resources data
The caregiver turnover rate will be expressed as the total number of caregiver departures divided by the total number of caregivers at t0.
Measured: at Day 0
Caregiver turnover rate in the participating hospitals departments, measured on the basis of human resources data
The caregiver turnover rate will be expressed as the total number of caregiver departures divided by the total number of caregivers at t1.
Measured: at Months 4
Caregiver turnover rate in the participating hospitals departments, measured on the basis of human resources data
The caregiver turnover rate will be expressed as the total number of caregiver departures divided by the total number of caregivers at t2.
Measured: at Months 8
Caregiver turnover rate in the participating hospitals departments, measured on the basis of human resources data
The caregiver turnover rate will be expressed as the total number of caregiver departures divided by the total number of caregivers at t3.
Measured: at Months 12
Ergonomic analysis of the activity on 2 participating hospital departments per hospital center and with voluntary caregivers, based on a qualitative approach consisting on interviews and observations
An ergonomic analysis of the activity on 2 participating hospital departments per hospital center and with voluntary caregivers, based on a qualitative approach consisting of interviews and observations of the real work of workers, through the methodology the ergonomics of the activity at t0, The data collected during the interviews will be analyzed by thematic analysis of the content and frequency of appearance of the categories determined from a standardized survey grid and the corpus of verbalizations. The data collected during the observations of the real work will be treated through an activity analysis grid that aims to identify and analyze the operating modes, the regulation strategies and the conflicts of goals and the arbitrations of the caregivers.
Measured: at Day 0
Ergonomic analysis of the activity on 2 participating hospital departments per hospital center and with voluntary caregivers, based on a qualitative approach consisting on interviews and observations
An ergonomic analysis of the activity on 2 participating hospital departments per hospital center and with voluntary caregivers, based on a qualitative approach consisting of interviews and observations of the real work of workers, through the methodology the ergonomics of the activity at t1.
Measured: at Months 4
Ergonomic analysis of the activity on 2 participating hospital departments per hospital center and with voluntary caregivers, based on a qualitative approach consisting on interviews and observations
An ergonomic analysis of the activity on 2 participating hospital departments per hospital center and with voluntary caregivers, based on a qualitative approach consisting of interviews and observations of the real work of workers, through the methodology the ergonomics of the activity at t2.
Measured: at Months 8
Ergonomic analysis of the activity on 2 participating hospital departments per hospital center and with voluntary caregivers, based on a qualitative approach consisting on interviews and observations
An ergonomic analysis of the activity on 2 participating hospital departments per hospital center and with voluntary caregivers, based on a qualitative approach consisting of interviews and observations of the real work of workers, through the methodology the ergonomics of the activity at t3.
Measured: at Months 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start5 Mar 2018
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational Exposure to BloodStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Conservatory of Arts and Crafts (Cnam) of Paris
- Responsible party
- Sponsor
- Investigators
- Pascal ASTAGNEAU, MD-PhD, Principal investigator, CPias Ile-de-France (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532321
- Sponsor's protocol ID
- NI16020J
- Acronym
- STRIPPS
- Status last verified
- Jan 2018
- First submitted
- 7 Feb 2018
- Last updated
- 22 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 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress at Work and Infectious Risk in Patients and Caregivers
- ClinicalTrials.gov ID
- NCT03532321
- Acronym / sponsor ID
- STRIPPS / NI16020J
- Keywords
- Stress, occupational risks, hospital organization, longitudinal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Conservatory of Arts and Crafts (Cnam) of Paris
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 22 May 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.
In hospitals, the improvement of working conditions is often considered secondarily to patient satisfaction. Previous studies, showing statistically significant relationships, suggested the impact of hospital departments' organization (staff / patient ratio, bed distribution, caregiver's assignment), of the work environment, and the working conditions on the infectious risk at the hospital departments. In addition, organizational hospital constraints and the organization of care could equally have a major impact on the physical and psychological health of care workers (stress, fatigue, job satisfaction). To date, available data suggest that determinants of occupational stress and fatigue are multifactorial.
This research aims to develop an interdisciplinary approach to link two phenomena that are often studied independently while they are closely intertwined: working conditions and infectious risk in hospitals departments. Their main objective is to study the relationship between stress and caregiver fatigue at the work, organizational determinants and infectious risk for patients (healthcare-associated infections: HAIs) and for caregivers (blood exposure accidents: BEAs). The secondary objective is to analyze how the individual characteristics of the staff, the characteristics of their employment, and the overall organization in the hospital departments where they work interact to explain their physical and psychological state of health, on the one hand, and their behavior face to work (absenteeism, turnover and hand hygiene) on the other hand. The ultimate goal of this research is to be able to propose organizational strategies aimed at both reducing the probability of occurrence of healthcare-associated infections and preventing occupational risks for caregivers.
Detailed description
STRIPPS is an etiologic, multi-center cohort study in the Ile-de-France region aiming to study better understands the complex relationship between the work organization, the stress ant and the caregiver fatigue and infectious risk in the hospital departments.
It will be conducted in 5 volunteer hospitals, with 7 to 8 hospital departments selected at random in each center and meeting eligibility inclusion criteria. The envisaged recruitment is approximately 20 staff per hospital department, enabling a total of about 150 staff to be included per center, totaling 750 surveyed caregivers.
The five voluntary centers will designate at least one local correspondent or referent among the hygiene team, the human resources (HR) department and the department of medical information system (DMI). The hygiene referent is the privileged correspondent. He will be part of the scientific committee and will help the investigators in the organization of the study within the hospital departments that will be drawn to participate. The HR and DMI referents are appointed to facilitate the collection of anonymous and aggregated data from the HR and PMSI databases planned for the study.
After obtaining regulatory authorizations, the eligible hospital departments of each hospital center will be drawn at random. Prior to the draw, hygiene referents of each hospital will prepare a list with all eligible hospital departments. Hospital departments will be selected using simple random sampling without replacement as follows in each list, the services will be numbered from 1 to n and 8 numbers between 1 and n will be chosen randomly using a computer. It will have a total of 5 lists (one list per hospital center) and 8 randomly selected numbers per list for a total of 40 randomly selected services. Similarly, visit days and survey start schedules will be drawn at random for the passage of an epidemiologist investigator recruited by the coordinating team. Two survey dates, between one Monday and one Friday of each week, and one survey start schedule, will be drawn at random for each work shift in every participating hospital department, during the entire inclusion period. Information meetings with the staff of the selected participating hospital departments and the communication by display will be organized by the investigators. A 15-day period will be left between the last information meeting held in the service and the closest date drawn for the start of the inclusion visits.
Based on a prospective data collection and using a qualitative-quantitative approach this study will provide some elements to better understand the complex relationship between the work organization, the stress and the caregiver fatigue, and infectious risk in the hospital departments (for patients and caregivers). This is an approach that relies on a conceptual model with several hypotheses to test. The conceptual diagram envisaged in our study has been based on the James Reason's model of accident causation. Indeed, it considers a multi-level interrelation of many factors ranging from organizational climate root causes to infectious risk. This equally includes contributory factors related to caregivers themselves, the care team, work environment as well as immediate causes related to care practices. Thus, for example, the infectious risk such as blood exposure accidents (for caregivers) or healthcare-associated infections (for patients) could be explained by several relationships between a wide range of factors: behavioral changes in care workers such as a decreased adherence with infection control measures as hand hygiene, stress and fatigue of caregivers, an excessive workload, a high nurse turnover or their absenteeism, the work schedules, as well as, by individual factors such as, the work experience, age, and the organizational climate as root causes.
In this research the following factors will be taken into account:
- at the organizational level: the type and size of hospital departments (in number of beds and in number of caregivers), the hourly organization of the staff, the number of caregivers by professional category for each shift in 24h;
- at the hospital department level: nurse absenteeism and turnover rates, safety culture, healthcare-associated infections rates, the rate of blood exposure accidents among caregivers, hand hygiene compliance rates;
- at the level of caregivers: age, sex, personal situation, number of young children, occupation, the position held, work experience, work schedules, stress and fatigue levels, blood exposure accidents, excessive work-related commitment, the social support from coworkers and from supervisors, current state of health, absences due to health reasons including absences due to accidents at work or for work-related illness, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | Other: NA : non interventional studyCaregivers in the participating hospital departments : medical (doctors, midwives) and paramedical (nurses' aides, registered nurses, specialized nurses and head nurses) staff, working in hospital departments drawn at random among five volunteer hospital centers in Paris, and who will be present at the time of investigator's passage, at a date drawn at random during the inclusion phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is the medical (doctors, midwives) and paramedical (nurses' aides, registered nurses, specialized nurses and head nurses) staff, working in hospital departments drawn at random among five volunteer hospital centers in Paris, and who will be present at the time of investigator's passage, at a date drawn at random during the inclusion phase.
Key inclusion criteria (9 listed)
- acute-care departments among medicine (including geriatrics and pediatrics), surgery, gynecology, obstetrics, intensive care, having at least 30 caregivers (medical and paramedical staff) working for the department.
- departments having low care activity such as the long-term care, follow-up care, and rehabilitation, psychiatric departments
- hospitals departments for which a closure or restructuring is in progress or planned within 15 months of the start of the investigation.
- statutory and contractual caregivers (nursing assistants, registered nurses, doctors or midwives) working at least at 0.5 full-time-equivalent who will be present at the time of inclusion visit, and having expressed their non-opposition to participate in the study.
- all interim (temporary) caregivers, medical students or interns or residents, as likely to change the hospital department during the investigation;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NA : non interventional studyNA : non interventional study | Other | Caregivers |
Primary outcome
Infectious risk in the participating hospital departments
Time frame: at Day 0
Incidence rate of blood exposure accidents (BEA) at t0 in the participating hospital departments. The BEA rate will be expressed as the report of the number of declared BEAs on the total number of caregivers interviewed during these periods.
Infectious risk in the participating hospital departments
Time frame: at Months 4
Incidence rate of blood exposure accidents (BEA) at t1 in the participating hospital departments. The BEA rate will be expressed as the report of the number of declared BEAs on the total number of caregivers interviewed during these periods.
Infectious risk in the participating hospital departments
Time frame: at Months 8
Incidence rate of blood exposure accidents (BEA) at t2 in the participating hospital departments. The BEA rate will be expressed as the report of the number of declared BEAs on the total number of caregivers interviewed during these periods.
Infectious risk in the participating hospital departments
Time frame: at Months 12
Incidence rate of blood exposure accidents (BEA) at t3 in the participating hospital departments. The BEA rate will be expressed as the report of the number of declared BEAs on the total number of caregivers interviewed during these periods.
Incidence rate of healthcare-associated infections (HAI)
Time frame: at Day 0
- The incidence rate of healthcare-associated infections (HAIs) among inpatients in the participating hospitals departments at t0. Data from the Program for Medicalization of Information Systems (PMSI) of each hospital center will be used as data source. The rate will be expressed as the report of the number of HAIs, listed in the PMSI as significant associated diagnosis, on the total number of hospitalized patients.
Incidence rate of healthcare-associated infections (HAI)
Time frame: at Months 4
- The incidence rate of healthcare-associated infections (HAIs) among inpatients in the participating hospitals departments at t0
Incidence rate of healthcare-associated infections (HAI)
Time frame: at Months 8
- The incidence rate of healthcare-associated infections (HAIs) among inpatients in the participating hospitals departments at t2
Incidence rate of healthcare-associated infections (HAI)
Time frame: at Months 12
- The incidence rate of healthcare-associated infections (HAIs) among inpatients in the participating hospitals departments at t3
24 secondary outcomes
Stress level of caregivers
Time frame: at Day 0
Stress level of caregivers
Time frame: at Months 4
Stress level of caregivers
Time frame: at Months 8
Stress level of caregivers
Time frame: at Months 12
Fatigue level of caregivers
Time frame: at Day 0
Fatigue level of caregivers
Time frame: at Months 4
Fatigue level of caregivers
Time frame: at Months 8
Fatigue level of caregivers
Time frame: at Months 12
Hand hygiene compliance rate in the participating hospital departments, measured via the GREPHH quick-audit system
Time frame: at Day 0
Hand hygiene compliance rate in the participating hospital departments, measured via the GREPHH quick-audit system
Time frame: at Months 4
Hand hygiene compliance rate in the participating hospital departments, measured via the GREPHH quick-audit system
Time frame: at Months 8
Hand hygiene compliance rate in the participating hospital departments, measured via the GREPHH quick-audit system
Time frame: at Months 12
Caregiver absenteeism rate in the participating hospital departments (absences due to health reasons including absences due to accidents at work or for work-related illness), measured on the basis of human resources data
Time frame: at Day 0
Caregiver absenteeism rate in the participating hospital departments (absences due to health reasons including absences due to accidents at work or for work-related illness), measured on the basis of human resources data
Time frame: at Months 4
Caregiver absenteeism rate in the participating hospital departments (absences due to health reasons including absences due to accidents at work or for work-related illness), measured on the basis of human resources data
Time frame: at Months 8
Caregiver absenteeism rate in the participating hospital departments (absences due to health reasons including absences due to accidents at work or for work-related illness), measured on the basis of human resources data
Time frame: at Months 12
Caregiver turnover rate in the participating hospitals departments, measured on the basis of human resources data
Time frame: at Day 0
Caregiver turnover rate in the participating hospitals departments, measured on the basis of human resources data
Time frame: at Months 4
Caregiver turnover rate in the participating hospitals departments, measured on the basis of human resources data
Time frame: at Months 8
Caregiver turnover rate in the participating hospitals departments, measured on the basis of human resources data
Time frame: at Months 12
Ergonomic analysis of the activity on 2 participating hospital departments per hospital center and with voluntary caregivers, based on a qualitative approach consisting on interviews and observations
Time frame: at Day 0
Ergonomic analysis of the activity on 2 participating hospital departments per hospital center and with voluntary caregivers, based on a qualitative approach consisting on interviews and observations
Time frame: at Months 4
Ergonomic analysis of the activity on 2 participating hospital departments per hospital center and with voluntary caregivers, based on a qualitative approach consisting on interviews and observations
Time frame: at Months 8
Ergonomic analysis of the activity on 2 participating hospital departments per hospital center and with voluntary caregivers, based on a qualitative approach consisting on interviews and observations
Time frame: at Months 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
Related trials for Occupational Exposure to Blood
RecruitingObservational study
Key Longitudinal Associations With Risk and Glioblastoma Outcomes
Glioblastoma
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.
Pascal ASTAGNEAU, MD-PhD principal investigator
CPias Ile-de-France (AP-HP)
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 Occupational Exposure to Blood and Healthcare-associated Related Infections, 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 9 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 22 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal ASTAGNEAU, MD, PhD (33 (0)1.40.27.42.00, pascal.astagneau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectious risk in the participating hospital departments (time frame: at Day 0). The study lists 8 primary outcomes in all. 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 22 May 2018.