Burn Out Among Medical Family Doctors

Anxiety Clinical Trial

— BOUM  

Official title:

Study of the Prevalence, Risk Factors and Protective Factors of Burnout Among General Practitioners in France

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04242862
• Other study ID #: 2016 BOUM
• Status: Recruiting
• Start date: November 1, 2016
• Est. completion date: June 1, 2022

Study information

• Verified date: January 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 0473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of this study is to assess the burnout prevalence among French general practitioners in private practice.

As secondary outcomes, this study aim to measure the impact of sociodemographic variables, organizational practice models and workload. the investigators also intend to characterize the prevalence of depression, anxiety, fatigue and stress, drugs and alcohol consumption, use of psychotropic medication, and preferred strategies to cope with their symptoms.

Description:

The BOUM protocol is designed to provide a better understanding of the current burnout prevalence among French general practitioners, as well as its risk and protective factors.

In order to fulfil those objectives, the methodologist estimated a 1536 individuals sample size, using an expected prevalence of severe burnout ranged between 10% and 20% (from the the EGPRN study - Soler, J.K., et al., Burnout in European family doctors: the EGPRN study. Family Practice, 2008. 25(4): p. 245-265), thus allowing the investigators to retrieve results with a 95% confidence level and a 2% error margin.

All analyses will be performed in a bilateral formulation for a 5% alpha error under the Stata® software (version 13, StataCorp, College Station, US). A difference will be considered statistically significant for p<0.05. The population will be described as frequency and percentage for the categorical variables, and as mean ± standard deviation or median [interquartile range] for the quantitative variables, according to their statistical distribution (normality studied by the Shapiro-Wilk test). Confidence intervals for population prevalence will be characterised with a binomial test. Comparisons between groups of burnout will be performed using Chi2 or Fisher's exact test for the categorical variables (followed by a Marascuillo post-hoc tests if needed), and by an ANOVA or Kruskal-Wallis test if normality and homoscedasticity not respected (Bartlett test) for the quantitative variables (followed by Tukey-Kramer or Dunn tests when necessary). Finally, considering the variables clinically relevant and those with a pertinent univariate analysis results, a multivariate analyse of ordinal polynomial regression type will be proposed; its results will be expressed as relative risk with 95% confidence intervals and presented as a Forest-plot.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1536
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• General practitioners working in France

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Anxiety
• Burnout, Professional
• Burnout, Psychological
• Depressive Disorder
• Mental Health Wellness 1
• Occupational Stress

Locations

Country	Name	City	State
France	CHU Clermont Ferrand	Clermont-Ferrand	Auvergne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	UFR Médecine & Pharmacie - Université Clermont Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Burnout in French General Practitioners	To evaluate the burnout prevalence in French General Practitioners, using the Maslach Burn-Out Inventory questionnaire	Day 1
Secondary	Anxiety	Hospital Anxiety and Depression scale will be assessed and related to with demographic information and occupational characteristics	Day 1
Secondary	Depression	Hospital Anxiety and Depression scalewill be assessed and related to with demographic information and occupational characteristics	Day 1
Secondary	Stress	Visual analog scale will be assessed and related to with demographic information and occupational characteristics	Day 1
Secondary	Fatigue	Visual analog scale will be assessed and related to with demographic information and occupational characteristics	Day 1
Secondary	sleep disturbance	Validated questionnaire will be assessed and related to with demographic information and occupational characteristics	Day 1
Secondary	Psychiatric history and clinical approaches	Participants will be asked about any previous psychiatric diagnosis, suicidal attempt, use of any psychotropic medication and usual stress management approaches.	Day 1
Secondary	Addictive behaviors	Alcohol, tobacco and other psychotropic drugs consumption, through questionnaires assessment	Day 1