Work-Related ConditionIOTA-REANCT03875521
Working Shift Organization, Caregivers' Satisfaction and Quality of Life at Work, and Performance.
An observational study of Work-Related Condition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This is a prospective, non-randomized, multicenter, observational national study, involving centers with different working shift organizations. Participating centers are 24 French adult intensive care units with different working shift organizations (12-hours shift vs. less than 12-hours shift) in public hospitals. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Work-Related Condition
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to Sep 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: volunteer caregivers: health care staff of 24 intensive care units will be included in the study: doctors, nurses and assistant nurses
Who may be able to join
- assistant nurses, nurses, doctors
- working in an hospital intensive care unit
Who cannot join
- opposition to use data
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
medical-surgical intensive care unit - TENON hospital (AP-HP)
Paris, 75020
Pierre-Yves Blanchard, RN, MSN, 00336 09 10 64 64, pierre-yves.blanchard@aphp.fr
Muriel Fartoukh, 00331 56 01 65 72, muriel.fartoukh@aphp.fr
About this study
Official title: Impact of the Working Shift Organization on the Caregivers' Satisfaction and Quality of Life at Work, and the Performance of the Intensive Care Units.
This is a prospective, non-randomized, multicenter, observational national study, involving centers with different working shift organizations.
Participating centers are 24 French adult intensive care units with different working shift organizations (12-hours shift vs. less than 12-hours shift) in public hospitals.
Read more
Caregivers (doctors, nurses and assistant nurses) constitute the population of the study.
The duration of the study is 13 months.
The aim of this study is to evaluate the impact of the working shift organizations on:
- The intensive care units operation;
- The use of outside staff;
- The caregivers' quality of life at work;
- The caregivers' satisfaction at work;
- The nursing work environment;
- Psychosocial and organisational work constraints
- The performance of the intensive care units;
- The costs and efficiency of the working shift organizations.
Read the detailed description
The critical review of the scientific literature leads us to conclude that there are heterogeneous, and sometimes discordant, results about the impact of a 12-hours working shift organizations on caregivers, hospitals and unit operation, compared with less than 12-hours working shift organizations. This variety and ambiguity of the results could stem from lack of documentation and/or lack of quality of the studies' methodology, the choice of the outcomes, a too short time period for analysis after an organizational change.
In addition, the sociologist analysis is rarely developed. Finally, quite a few studies are declarative, therefore, whatsoever objective outcome is measured.
The determinants of the choice of working shift organization in health facilities are interlinked with multiple factors. Individual and economic factors are considered, as well as clinical risk management, continuity of care and continuity of public services. To the best of our knowledge, no study have evaluated the capacity to maintain a continuity of public health services using 12-hours working shift organization, in particular in French intensive care units subjected to a regulation on nursing and assistant nursing workforce per patient. Besides, there is no data about the impact of 12-hours working shift organization on the performance of intensive care units regarding clinical risk management.
Our hypothesis is that a 12-hours working shift organization may result in a more important number of hours during which the French standard ratio of 1 nurse for 2.5 patients is observed or during which the intensive care beds are not closed, compared with a less than 12-hours working shift organization, with similar caregivers quality of life and performance of intensive care units.
First month of the study: self-administered questionnaires used in order to evaluate nursing work environment (Practice Environment Scale of the Nursing Work Index PES-NWI), caregivers quality of life at work (Nottingham Health Profile NHP, Perceived Stress Scale PSS10 and Hospital Anxiety and Depression Scale HADS) caregivers satisfaction at work (Minnesota Satisfaction Questionnaire MSQ) and psychosocial and organisational work constraints (NWI-EO) will be completed by caregivers (doctors, nurses and assistant nurses).
During the study a sociologist will carry semi-structured interviews on a subset of caregivers from different participating centers.
Eleventh month: self-administered questionnaires used during the first month of the study will be completed again by all caregivers under the same conditions.
One year study period: human resources, activity and performance data will be collected from the beginning to the end of the study.
- Conditions
- Work-Related Condition
- Keywords
- Work Schedule Tolerance, Observational Study, Intensive Care Units/manpower, Job Satisfaction
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 |
|---|---|---|
| 12 hours | Not described | |
| < 12hours | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensive care units operation
Percentage of hours during which the French standard ratio of 1 nurse for 2.5 patients in intensive care units is not observed or during which intensive care beds are closed
Measured: during 1 year
Secondary outcomes (9)
use of outside staff
number of hours during which outside staff is used in participating units (temporary staff, staff working overtime or dedicated supply team staff) during unannounced work stoppages
Measured: during 1 year
caregivers' quality of life at work
doctors, nurses and assistant nurses quality of life at work evaluated by using Nottingham Health Profile (NHP)
Measured: first and eleventh months of the study
caregivers' quality of life at work
doctors, nurses and assistant nurses quality of life at work evaluated by using Hospital Anxiety and Depression Scale (HADS)
Measured: first and eleventh months of the study
caregivers' quality of life at work
doctors, nurses and assistant nurses quality of life at work evaluated by using Perceived Stress Scale (PSS10)
Measured: first and eleventh months of the study
caregivers' satisfaction at work
Caregivers' satisfaction at work evaluated with the Minnesota Satisfaction Questionnaire (20-MSQ) and individual interviews with a sociologist.
Measured: first and eleventh months of the study
Nursing Work Environment
Evaluated with aggregated data of services (absenteeism rate, delay of recruitment, nurses/patient ratio, assistant nurses/patient ratio, nurses/doctor ratio, assistant nurses/doctor ratio, doctors/patient ratio, number of nurse manager, number of hours worked beyond the expected range, bed occupancy rate, number of days during which beds are unexpectedly closed) and compared between the group of twelve hours working and the less than twelve hours working.
Measured: During one year
Measure of the performance of intensive care units
adverse events defined as death in intensive care units (matched to IGS2), and/or adverse events (self-extubation) and/or healthcare-associated infections (bacteremia and sepsis on non-bacteremia catheters)
Measured: during 1 year
Budgetary impact
The main outcome measure is the total costs (in €) measured by the total labor costs. Labor will be estimated in full-time equivalents, recorded on the time sheets for both medical and non-medical staff.
The outcome measure is in € and FTEs
Measured: during one year
psychosocial and organisational work constraints
nurses' and assistant nurses' psychosocial and organisational work constraints evaluated with the Nursing Work Index - Extended Organisation (NWI-EO) questionnaire
Measured: first and eleventh months of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Jun 2019
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work-Related ConditionStudies 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
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Yves BLANCHARD, RN, MSN, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875521
- Sponsor's protocol ID
- NI17057HLJ
- Acronym
- IOTA-REA
- Status last verified
- Jul 2019
- First submitted
- 7 Dec 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Working Shift Organization on the Caregivers' Satisfaction and Quality of Life at Work, and the Performance of the Intensive Care Units.
- ClinicalTrials.gov ID
- NCT03875521
- Acronym / sponsor ID
- IOTA-REA / NI17057HLJ
- Conditions
- Work-Related Condition
- Keywords
- Work Schedule Tolerance, Observational Study, Intensive Care Units/manpower, Job Satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 14 Mar 2019 (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.
This is a prospective, non-randomized, multicenter, observational national study, involving centers with different working shift organizations.
Participating centers are 24 French adult intensive care units with different working shift organizations (12-hours shift vs. less than 12-hours shift) in public hospitals.
Caregivers (doctors, nurses and assistant nurses) constitute the population of the study.
The duration of the study is 13 months.
The aim of this study is to evaluate the impact of the working shift organizations on:
- The intensive care units operation;
- The use of outside staff;
- The caregivers' quality of life at work;
- The caregivers' satisfaction at work;
- The nursing work environment;
- Psychosocial and organisational work constraints
- The performance of the intensive care units;
- The costs and efficiency of the working shift organizations.
Detailed description
The critical review of the scientific literature leads us to conclude that there are heterogeneous, and sometimes discordant, results about the impact of a 12-hours working shift organizations on caregivers, hospitals and unit operation, compared with less than 12-hours working shift organizations. This variety and ambiguity of the results could stem from lack of documentation and/or lack of quality of the studies' methodology, the choice of the outcomes, a too short time period for analysis after an organizational change.
In addition, the sociologist analysis is rarely developed. Finally, quite a few studies are declarative, therefore, whatsoever objective outcome is measured.
The determinants of the choice of working shift organization in health facilities are interlinked with multiple factors. Individual and economic factors are considered, as well as clinical risk management, continuity of care and continuity of public services. To the best of our knowledge, no study have evaluated the capacity to maintain a continuity of public health services using 12-hours working shift organization, in particular in French intensive care units subjected to a regulation on nursing and assistant nursing workforce per patient. Besides, there is no data about the impact of 12-hours working shift organization on the performance of intensive care units regarding clinical risk management.
Our hypothesis is that a 12-hours working shift organization may result in a more important number of hours during which the French standard ratio of 1 nurse for 2.5 patients is observed or during which the intensive care beds are not closed, compared with a less than 12-hours working shift organization, with similar caregivers quality of life and performance of intensive care units.
First month of the study: self-administered questionnaires used in order to evaluate nursing work environment (Practice Environment Scale of the Nursing Work Index PES-NWI), caregivers quality of life at work (Nottingham Health Profile NHP, Perceived Stress Scale PSS10 and Hospital Anxiety and Depression Scale HADS) caregivers satisfaction at work (Minnesota Satisfaction Questionnaire MSQ) and psychosocial and organisational work constraints (NWI-EO) will be completed by caregivers (doctors, nurses and assistant nurses).
During the study a sociologist will carry semi-structured interviews on a subset of caregivers from different participating centers.
Eleventh month: self-administered questionnaires used during the first month of the study will be completed again by all caregivers under the same conditions.
One year study period: human resources, activity and performance data will be collected from the beginning to the end of the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 hours | – | – |
| < 12hours | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- volunteer caregivers: health care staff of 24 intensive care units will be included in the study: doctors, nurses and assistant nurses
Key inclusion criteria (2 listed)
- assistant nurses, nurses, doctors
- working in an hospital intensive care unit
Key exclusion criteria (1 listed)
- opposition to use data
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
intensive care units operation
Time frame: during 1 year
Percentage of hours during which the French standard ratio of 1 nurse for 2.5 patients in intensive care units is not observed or during which intensive care beds are closed
9 secondary outcomes
use of outside staff
Time frame: during 1 year
caregivers' quality of life at work
Time frame: first and eleventh months of the study
caregivers' quality of life at work
Time frame: first and eleventh months of the study
caregivers' quality of life at work
Time frame: first and eleventh months of the study
caregivers' satisfaction at work
Time frame: first and eleventh months of the study
Nursing Work Environment
Time frame: During one year
Measure of the performance of intensive care units
Time frame: during 1 year
Budgetary impact
Time frame: during one year
psychosocial and organisational work constraints
Time frame: first and eleventh months of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Pierre-Yves BLANCHARD, RN, MSN 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 Work-Related Condition, 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 2 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: status not confirmed, as of the sponsor's last update on 25 Jul 2019. 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 Pierre-Yves BLANCHARD, RN, MSN (00336 09 10 64 64, pierre-yves.blanchard@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intensive care units operation (time frame: during 1 year). 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 25 Jul 2019.