- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04010773
Impact at Two Years of an Intervention Program on the Empowerment of Medical and Nursing Teams in a French Hospital (CHRYSALIDE)
Project for the Liberation of Organizations in an University Hospital in France: A Randomized Controlled Study of the Impact at Two Years of an Intervention Program on the Empowerment of the Medical and Nursing Teams
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nantes, France, 44093
- Nantes University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Structural empowerment, assessed with the Conditions for Work Effectiveness Questionnaire II (CWEQII).
Time Frame: 12 months and 24 months after initial measure.
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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.
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12 months and 24 months after initial measure.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological empowerment, assessed with the Psychological Empowerment Scale (PES).
Time Frame: 12 months and 24 months after initial measure.
|
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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Baptiste Cougot, CHU de Nantes
Publications and helpful links
General Publications
- Cougot B, Gillet N, Gauvin J, Caillet P, Fleury-Bahi G, Ollierou F, Armant A, Peltier A, Getz I, Bach-Ngohou K, Tripodi D, Moret L. Impact of empowering leadership on emotional exhaustion: A controlled interventional study in a large French university hospital complex. J Nurs Manag. 2022 Nov;30(8):4234-4250. doi: 10.1111/jonm.13829. Epub 2022 Oct 17.
- Cougot B, Gauvin J, Gillet N, Bach-Ngohou K, Lesot J, Getz I, Deparis X, Longuenesse C, Armant A, Bataille E, Leclere B, Fleury-Bahi G, Moret L, Tripodi D. Impact at two years of an intervention on empowerment among medical care teams: study protocol of a randomised controlled trial in a large French university hospital. BMC Health Serv Res. 2019 Dec 3;19(1):927. doi: 10.1186/s12913-019-4724-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RC17_0014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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