- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06926296
Moral Injury in French Healthcare Workers (MI-PRO)
Healthcare professionals are facing an escalating crisis, with burnout rates ranging between 40% and 60% and a growing intention to leave the profession, affecting one in five physicians and one in four nurses in the coming years. While current interventions focused on individual resilience, such as mindfulness, peer support, and workload management, have been promoted as solutions, they have failed to bring about systemic improvements. This raises the question of whether other factors, such as Moral Injury, play a key role in this crisis. Moral Injury is an emerging concept that highlights the profound misalignment between healthcare workers' professional values and the reality of their practice, often exacerbated by organizational and economic constraints.
The objective of this study is to describe the manifestations of Moral Injury among healthcare professionals in France. By establishing the first large-scale assessment of Moral Injury among healthcare professionals in France, this study aims to identify key organizational and personal risk factors contributing to this phenomenon. The use of Structural Equation Modeling will help build a robust theoretical model that clarifies the underlying mechanisms of Moral Injury and its interactions with broader health issues. The findings will support the development of targeted interventions focused on systemic organizational changes to improve healthcare workers' well-being and guide public health policies.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Healthcare professionals are facing an escalating crisis, with burnout rates ranging between 40% and 60% and a growing intention to leave the profession, affecting one in five physicians and one in four nurses in the coming years. While current interventions focused on individual resilience, such as mindfulness, peer support, and workload management, have been promoted as solutions, they have failed to bring about systemic improvements. This raises the question of whether other factors, such as Moral Injury, play a key role in this crisis. Moral Injury is an emerging concept that highlights the profound misalignment between healthcare workers' professional values and the reality of their practice, often exacerbated by organizational and economic constraints.
The primary objective of this study is to describe the manifestations of Moral Injury among healthcare professionals in France. Secondary objectives include the psychometric validation of a French-language Moral Injury scale, the analysis of organizational and individual determinants of Moral Injury, and the structural modeling of underlying mechanisms.
This nationwide cross-sectional survey will be conducted electronically, reaching participants through healthcare institutions, professional societies, social networks, and a snowball dissemination strategy. Data collection will include standardized scales such as the Moral Injury Inventory for Healthcare Professionals, the Moral Injury Events Scale (MIES), the Maslach Burnout Inventory (MBI), and the EuroQol 5-Dimensions (EQ-5D) for quality of life, as well as ad hoc questions designed to explore additional systemic and professional challenges. A rigorous psychometric validation of the Moral Injury scale will be performed, followed by Structural Equation Modeling (SEM) to analyze the complex relationships between Moral Injury and other factors such as burnout, depression, and anxiety.
By establishing the first large-scale assessment of Moral Injury among healthcare professionals in France, this study aims to identify key organizational and personal risk factors contributing to this phenomenon. The use of Structural Equation Modeling will help build a robust theoretical model that clarifies the underlying mechanisms of Moral Injury and its interactions with broader health issues. The findings will support the development of targeted interventions focused on systemic organizational changes to improve healthcare workers' well-being and guide public health policies.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sophie LAFOND
- Phone Number: +33 0483772062
- Email: sophie.lafond@ch-toulon.fr
Study Locations
-
-
Var
-
Toulon, Var, France, 83100
- Recruiting
- Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer
-
Contact:
- Sophie LAFOND
- Phone Number: +33 0483772062
- Email: sophie.lafond@ch-toulon.fr
-
Principal Investigator:
- Laurent BOYER, Pr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthcare workers
Exclusion Criteria:
- Absence of consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Healthcare workers
All health professionals working in metropolitan France and the French overseas departments and territories
|
Health workers will be invited to complete an online self-questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moral Injury Inventory for Healthcare Professionals
Time Frame: One point : baseline
|
An overall score out of 100 will be created for the inventory, where a high score indicates a high level of "Moral Injury"
|
One point : baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moral Injury Events Scale
Time Frame: One point : baseline
|
Minimum score = 11, Maximum score = 66 Higher average scores indicate greater intensity of experience
|
One point : baseline
|
|
Maslach Burnout Inventory
Time Frame: One point : baseline
|
3 scores calculated in this inventory Burnout : minimum score = 0, maximum score = 63, Higher average scores indicate greater intensity of burnout Depersonalization : minimum score = 0, maximum score = 35, Higher average scores indicate greater intensity of depersonalization Personal fulfillment : minimum score = 0, maximum score = 56, Higher average scores indicate greater intensity of personal fulfillment
|
One point : baseline
|
|
EuroQol 5-Dimensions (EQ-5D)
Time Frame: One point : baseline
|
Scores range from -0.59 to 1, where 1 is the best possible health status.
|
One point : baseline
|
Collaborators and Investigators
Investigators
- Study Director: Laurent BOYER, Pr, CEReSS
Publications and helpful links
General Publications
- Boyer L, Fond G, Tran B, Llorca PM, Duclos A. The hidden crisis: Moral injury among French healthcare workers. J Epidemiol Popul Health. 2024 Dec;72(6):202780. doi: 10.1016/j.jeph.2024.202780. Epub 2024 Oct 19.
- Dean W, Morris D, Llorca PM, Talbot SG, Fond G, Duclos A, Boyer L. Moral Injury and the Global Health Workforce Crisis - Insights from an International Partnership. N Engl J Med. 2024 Sep 5;391(9):782-785. doi: 10.1056/NEJMp2402833. Epub 2024 Aug 31. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-CHITS-019
- 2024-a02449-38 (Other Identifier: ID-RCB number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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