Stress at Work and Infectious Risk in Patients and Caregivers

NCT03532321 | Unknown

• 1 other identifier: NI16020J
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Occupational Exposure to Blood; Healthcare-associated Related Infections; Stress; Fatigue

Keywords

Stress; occupational risks; hospital organization; longitudinal

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (24)

• Stress level of caregivers

  at Day 0

• Stress level of caregivers

  at Months 4

• Stress level of caregivers

  at Months 8

• Stress level of caregivers

  at Months 12

• Fatigue level of caregivers

  at Day 0

Study Arms (1)

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

Interventions

NA : non interventional study OTHER

NA : non interventional study

Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.
• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• National Conservatory of Arts and Crafts (Cnam) of Paris: collaborator

Study Sites (1)

Assistance publique - Hôpitaux de Paris

Paris, France

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pascal ASTAGNEAU, MD-PhD

  CPias Ile-de-France (AP-HP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal ASTAGNEAU, MD, PhD

CONTACT

33 (0)1.40.27.42.00; pascal.astagneau@aphp.fr

Kariuska MILIANI, MD, PhD

CONTACT

33 (0)1.40.27.42.12; katiuska.miliani@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: May 22, 2018
• Study Start: March 5, 2018
• Primary Completion: September 1, 2019
• Study Completion: March 1, 2020
• Last Updated: May 22, 2018

Record last verified: 2018-01

Locations

FR (1)