- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431372
Validation of the Shared Happiness Index in Multidisciplinary Primary Care Practices ( Be aPi ) (Be aPi)
Validation of the Shared Happiness Index in Multidisciplinary Primary Care Practices
Multi-professional primary care practices (Maisons de Santé Pluriprofessionnelles, MSP) have expanded widely in France over the last decade to respond to increasing healthcare needs, uneven distribution of physicians, and deteriorating working conditions, which were further exacerbated by the COVID-19 pandemic. MSPs are expected to offer more collaborative and coordinated care, and to provide a more attractive work environment, particularly for younger healthcare professionals seeking less isolation and better work-life balance.
Well-being at work for healthcare professionals is now recognised as a key determinant of quality and safety of care. Studies have shown links between staff satisfaction, burnout, and patient outcomes, including communication quality, error rates and staff retention. However, research specifically focused on collective well-being or "shared happiness" within multi-professional primary care teams remains limited. Existing work in French MSPs (notably qualitative studies by F. Burté and O. Caillaud) has identified relevant dimensions of "shared happiness" and led to the preliminary construction of a questionnaire named the Shared Happiness Index (Indice de Bonheur Partagé, IBP). To date, no validated, standardised instrument exists to measure this collective well-being in MSPs.
The Be_aPi study aims to validate the IBP questionnaire among healthcare professionals working in MSPs. The study is observational, descriptive and cross-sectional, conducted in several French regions covered by the GIRCI (Groupement Interrégional de Recherche Clinique et Innovation) SOHO (Sud-Ouest Outre-Mer Hospitalier) network (Nouvelle-Aquitaine, Occitanie, Réunion and Mayotte). It comprises three main steps. First, a content validation phase will be carried out with two independent panels of experts. One panel, including psychometrics, methodology and linguistics experts and MSP representatives, will assess face validity by examining each item in relation to the concept of shared happiness in multi-professional primary care. A second panel will be involved in an e-Delphi process to establish consensus validity on the relevance and clarity of items, using Likert-type ratings and iterative feedback.
Second, the psychometric validation phase will recruit approximately 350 professionals from over 100 MSPs. Eligible participants include medical and paramedical professionals, medical-social staff, medical assistants, coordinators, health mediators, adapted physical activity instructors and psychologists, working in MSPs that have been operating for at least one year, with at least one year of seniority in their current MSP. Participants will complete an online survey including the IBP questionnaire and three reference instruments: the Maslach Burnout Inventory (MBI), the General Health Questionnaire-12 (GHQ-12) and the Short Form-12 (SF-12). Internal consistency of the IBP will be assessed using Cronbach's alpha, and construct validity will be examined with exploratory factor analysis and correlation patterns with the reference scales, according to a multi-trait multi-method approach.
Third, to evaluate test-retest reliability, participants who completed the initial IBP will be invited to fill in the same questionnaire again after a delay of approximately one month. The stability of scores over time will be assessed using intraclass correlation coefficients. Ceiling and floor effects, as well as the distribution of scores across professional categories and organisational characteristics of MSPs (e.g. single-site vs multi-site, role in the organisation, membership in interprofessional associations), will also be analysed.
The expected outcome of Be_aPi is a valid, reliable and transferable Shared Happiness Index specifically tailored to multi-professional primary care practices. This tool should enable regular monitoring of collective well-being, support targeted quality-of-work-life interventions, and ultimately contribute to improving quality and safety of care, staff retention and the long-term sustainability of MSPs. In the longer term, the IBP could inform policy instruments and financing schemes that aim to "take care of those who care," in line with national quality and safety strategies.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Vanessa PALMA, MD
- Phone Number: +262692211902
- Email: vanessa.palma@univ-reunion.fr
Study Locations
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La Possession, Reunion
- Sakisoigne Health Centre
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Contact:
- Vanessa PALMA, MD
- Phone Number: +262692211902
- Email: vanessa.palma@univ-reunion.fr
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Contact:
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Principal Investigator:
- Vanessa PALMA, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthcare professionals (medical, paramedical) and professionals in the medical-social sector, medical assistants, health coordinators and mediators, as well as adapted physical activity instructors and psychologists
- who work in healthcare centres that had been operating for more than one year at the start of the study and who themselves had more than one year's seniority in the MSP.
Exclusion Criteria:
- Substitute professionals,
- Secretaries without coordination or medical assistant duties Professionals belonging to MSPs that had been operating for less than one year at the start of the study and who had less than one year's seniority within the organisation.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Consensus validity - eDELPHI method
Time Frame: before first participant inclusion
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Evaluation of items in the Shared Happiness Index questionnaire using a Likert scale from 1 to 5 (1 = does not measure the concept studied at all and 5 = measures the concept studied completely) Analysis of responses to identify points of agreement and disagreement, then transmission of an anonymous summary of responses and comments to the entire panel.
Repetition of these steps, refining the questionnaire with each round until consensus is reached or feedback converges.
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before first participant inclusion
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Face validity
Time Frame: Before first participant inclusion
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Define each item in the questionnaire by a committee of experts.
Analyze the items one by one by the committee and relate them to the concept being studied, shared happiness, in the context of a multi-professional healthcare facility.
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Before first participant inclusion
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Internal consistency - Cronbach's alpha
Time Frame: Month 1
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Internal consistency measures the extent to which the items in the test measure the same dimension or concept, in this case shared happiness. Internal consistency is commonly measured by Cronbach's alpha, which ranges from 0 (low) to 1 (high). A high coefficient indicates that the test items are similar in content, i.e. homogeneous. A Cronbach's alpha greater than 0.7 is acceptable. |
Month 1
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test-retest reliability - intraclass coefficient (ICC)
Time Frame: month 1
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Consistency of results over time for the same sample of subjects. This will be assessed by proposing that the initial sample complete the questionnaire again after a period of one month. Estimation by intraclass coefficient. ICC ranges from 0 to 1. An ICC close to 1 indicates a high degree of agreement between measurements. Conversely, an ICC close to 0 indicates low agreement. |
month 1
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Construct validity - Exploratory Factor Analysis
Time Frame: day 1
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Allows us to visualize the construction of the tool and the concept measured by the questionnaire. Construct validity will be assessed across all items selected during the content validation phase. the construct validity will be assessed using exploratory factor analysis |
day 1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025RUN0051
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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