Stress Clinical Trial
— STRIPPSOfficial title:
Stress at Work and Infectious Risk in Patients and Caregivers
NCT number | NCT03532321 |
Other study ID # | NI16020J |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 5, 2018 |
Est. completion date | March 1, 2020 |
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.
Status | Recruiting |
Enrollment | 750 |
Est. completion date | March 1, 2020 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
France | Assistance publique - Hôpitaux de Paris | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | National Conservatory of Arts and Crafts (Cnam) of Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
at Day 0 | |
Primary | 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. |
at Months 4 | |
Primary | 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. |
at Months 8 | |
Primary | 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. |
at Months 12 | |
Primary | 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. | at Day 0 | |
Primary | Incidence rate of healthcare-associated infections (HAI) | - The incidence rate of healthcare-associated infections (HAIs) among inpatients in the participating hospitals departments at t0 | at Months 4 | |
Primary | Incidence rate of healthcare-associated infections (HAI) | - The incidence rate of healthcare-associated infections (HAIs) among inpatients in the participating hospitals departments at t2 | at Months 8 | |
Primary | Incidence rate of healthcare-associated infections (HAI) | - The incidence rate of healthcare-associated infections (HAIs) among inpatients in the participating hospitals departments at t3 | at Months 12 | |
Secondary | 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. | at Day 0 | |
Secondary | 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. | at Months 4 | |
Secondary | 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. | at Months 8 | |
Secondary | 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. | at Months 12 | |
Secondary | 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. | at Day 0 | |
Secondary | 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. | at Months 4 | |
Secondary | 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. | at Months 8 | |
Secondary | 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. | at Months 12 | |
Secondary | 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. | at Day 0 | |
Secondary | 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. | at Months 4 | |
Secondary | 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. | at Months 8 | |
Secondary | 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. | at Months 12 | |
Secondary | 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. | at Day 0 | |
Secondary | 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. | at Months 4 | |
Secondary | 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. | at Months 8 | |
Secondary | 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. | at Months 12 | |
Secondary | 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. | at Day 0 | |
Secondary | 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. | at Months 4 | |
Secondary | 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. | at Months 8 | |
Secondary | 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. | at Months 12 | |
Secondary | 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. | at Day 0 | |
Secondary | 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. | at Months 4 | |
Secondary | 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. | at Months 8 | |
Secondary | 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. | at Months 12 |
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