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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04010773
Other study ID # RC17_0014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 16, 2018
Est. completion date August 30, 2021

Study information

Verified date June 2019
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Health in France asks public hospitals to promote quality of working life (QWL), seen as a performance factor. Consistently with empowerment literature, they define QWL as giving workers mastery over their working life. The problem is, French hospitals follow a bureaucratic model, defined by a managerial culture of control and a stratified organization, which weakens mastery of their work, and hinders their commitment and performance. Main objective of CHRYSALIDE, is to create a managerial and organizational transition program of 1 year, and to test its effect at two years on workers empowerment in an university hospital Sub-Center (SC), in comparison with another SC from the same University Hospital Center (CHU) in a randomized controlled study design.


Description:

The main objective of CHRYSALIDE is to implement an easy-to-replicate intervention program of 1 year, in order to promote empowering behaviors in directors and front line supervisors in SC, and to test its impact at two years on workers scores of structural empowerment, in comparison with another SC from the same University Hospital Center (CHU). The secondary objective is to assess the effect of the intervention on psychological empowerment. To answer to the main objective, quantitative data will be collected three times during the project: Before the implementation, directly after the intervention, and 1 year after the end of the intervention, or 2 years after the beginning. To improve our understanding of what happened during the intervention, a systematic ethnographic report will be done by the investigators and the facilitators engaged in the intervention. Quantitative data collection will occur during the occupational health visit that is required to be done every two years considering French legislation. For the need of the study, visits will be done every years, and scheduled to match with the beginning and the end of the intervention. Quantitative data consist in (1) self-reported questionnaires, (2) standardized assessment by medical practitioner during the visit, (3) institutional indicators routinely collected by the SC.


Recruitment information / eligibility

Status Completed
Enrollment 1191
Est. completion date August 30, 2021
Est. primary completion date October 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Working in one of the care units of the SC that has been randomly selected to benefit from the intervention. Exclusion Criteria: Criteria for not including UHPs - Capacity-building or major reorganization planned during the study period. Criteria for not including services - Chiefdom of the service opposed to the intervention. - Strike movement in the team during the inclusion phase. Criteria for not including professionals - Refusal to participate in the study. - Physical or psychological condition that prevents the completion of questionnaires.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
collective and psycho-social intervention
The intervention duration is 1 year. It combine (1) In each unit, working groups aimed at improving QWL, (2) counseling and training of directors and frontline managers, and (3) in each unit, concertation meeting between workers, front-line managers and directors.

Locations

Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Structural empowerment, assessed with the Conditions for Work Effectiveness Questionnaire II (CWEQII). This self-reported questionnaire is composed of 19 items about how the worker perceives his work environment. They allow calculation of 6 sub-scores and 1 global score of structural empowerment, reflecting access to the aspects of work environment known to mediate the control of workers over their job. The subscores are "formal power", "informal power", "opportunity", "information", "support" and "resources". They are calculated by summing their specific items, and dividing by 3, except for "informal power" for which the sum is divided by 4. Every sub-score is between 1 and 5. The global score of structural empowerment is calculated by summing the 6 sub-scores. The global score is between 5 and 30. There is not any threshold for the sub-scores and the global score: the higher the scores, the more empowering the working conditions are. The global score is the primary outcome in this study. Safety issue : No. 12 months and 24 months after initial measure.
Secondary Psychological empowerment, assessed with the Psychological Empowerment Scale (PES). This self-reported questionnaire is composed of 12 items. They allow calculation of 4 sub-scores and 1 global score of psychological empowerment, reflecting cognitions-believes people with power have about themselves. The sub-scores are "autonomy", "impact", "competence" and "meaning". The sub-scores are calculated by summing their specific items. They are between 15 and 25. The global score is calculated by summing the sub-scores and dividing by 4. It is between 15 and 25. There is not any threshold for the global and sub-scores: the higher the scores, the more people are psychologically empowered. The global score of psychological empowerment is considered as a secondary outcome in this study.
Safety Issue: No
12 months and 24 months after initial measure.
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