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Stress at Work and Infectious Risk in Patients and Caregivers (STRIPPS)

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ClinicalTrials.gov Identifier: NCT03532321
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
National Conservatory of Arts and Crafts (Cnam) of Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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 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.


Condition or disease Intervention/treatment
Occupational Exposure to Blood Healthcare-associated Related Infections Stress Fatigue Other: NA : non interventional study

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress at Work and Infectious Risk in Patients and Caregivers
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Group/Cohort Intervention/treatment
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.
Other: NA : non interventional study
NA : non interventional study




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.

  6. 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

  7. 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

  8. 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


Secondary Outcome Measures :
  1. Stress level of caregivers [ Time Frame: at Day 0 ]
    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.

  2. Stress level of caregivers [ Time Frame: at Months 4 ]
    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.

  3. Stress level of caregivers [ Time Frame: at Months 8 ]
    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.

  4. Stress level of caregivers [ Time Frame: at Months 12 ]
    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.

  5. Fatigue level of caregivers [ Time Frame: at Day 0 ]
    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.

  6. Fatigue level of caregivers [ Time Frame: at Months 4 ]
    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.

  7. Fatigue level of caregivers [ Time Frame: at Months 8 ]
    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.

  8. Fatigue level of caregivers [ Time Frame: at Months 12 ]
    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.

  9. Hand hygiene compliance rate in the participating hospital departments, measured via the GREPHH quick-audit system [ Time Frame: at Day 0 ]
    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.

  10. Hand hygiene compliance rate in the participating hospital departments, measured via the GREPHH quick-audit system [ Time Frame: at Months 4 ]
    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.

  11. Hand hygiene compliance rate in the participating hospital departments, measured via the GREPHH quick-audit system [ Time Frame: at Months 8 ]
    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.

  12. Hand hygiene compliance rate in the participating hospital departments, measured via the GREPHH quick-audit system [ Time Frame: at Months 12 ]
    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.

  13. 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 ]
    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.

  14. 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 ]
    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.

  15. 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 ]
    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.

  16. 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 ]
    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.

  17. Caregiver turnover rate in the participating hospitals departments, measured on the basis of human resources data [ Time Frame: at Day 0 ]
    The caregiver turnover rate will be expressed as the total number of caregiver departures divided by the total number of caregivers at t0.

  18. Caregiver turnover rate in the participating hospitals departments, measured on the basis of human resources data [ Time Frame: at Months 4 ]
    The caregiver turnover rate will be expressed as the total number of caregiver departures divided by the total number of caregivers at t1.

  19. Caregiver turnover rate in the participating hospitals departments, measured on the basis of human resources data [ Time Frame: at Months 8 ]
    The caregiver turnover rate will be expressed as the total number of caregiver departures divided by the total number of caregivers at t2.

  20. Caregiver turnover rate in the participating hospitals departments, measured on the basis of human resources data [ Time Frame: at Months 12 ]
    The caregiver turnover rate will be expressed as the total number of caregiver departures divided by the total number of caregivers at t3.

  21. 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 ]
    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.

  22. 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 ]
    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.

  23. 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 ]
    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.

  24. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

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.

Inclusion criteria for caregivers:

- 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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532321


Contacts
Contact: Pascal ASTAGNEAU, MD, PhD 33 (0)1.40.27.42.00 pascal.astagneau@aphp.fr
Contact: Kariuska MILIANI, MD, PhD 33 (0)1.40.27.42.12 katiuska.miliani@aphp.fr

Locations
France
Assistance publique - Hôpitaux de Paris Recruiting
Paris, France
Contact: Pascal ASTAGNEAU, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Conservatory of Arts and Crafts (Cnam) of Paris
Investigators
Principal Investigator: Pascal ASTAGNEAU, MD-PhD CPias Ile-de-France (AP-HP)

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03532321     History of Changes
Other Study ID Numbers: NI16020J
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Stress
occupational risks
hospital organization
longitudinal

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms