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Impact at Two Years of an Intervention Program on the Empowerment of Medical and Nursing Teams in a French Hospital (CHRYSALIDE)

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ClinicalTrials.gov Identifier: NCT04010773
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date June 27, 2019
First Posted Date July 8, 2019
Last Update Posted Date July 8, 2019
Actual Study Start Date January 16, 2018
Estimated Primary Completion Date December 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 4, 2019)
Structural empowerment, assessed with the Conditions for Work Effectiveness Questionnaire II (CWEQII). [ Time Frame: 12 months and 24 months after initial measure. ]
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 4, 2019)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact at Two Years of an Intervention Program on the Empowerment of Medical and Nursing Teams in a French Hospital
Official Title 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
Brief 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.
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 Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population all professionals working in the care services of the experimental and control UPHs.
Condition Empowerment
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.
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 4, 2019)
1194
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 16, 2020
Estimated Primary Completion Date December 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Baptiste Cougot 02 44 76 69 19 baptiste.cougot@chu-nantes.fr
Contact: Jules Gauvin 02 44 76 69 19 jules.gauvin@chu-nantes.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04010773
Other Study ID Numbers RC17_0014
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Baptiste Cougot CHU DE NANTES
PRS Account Nantes University Hospital
Verification Date June 2019