Ignite Creation Date:
2024-05-06 @ 2:11 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04242862
Status:
UNKNOWN
Last Update Posted:
2020-01-27
First Post:
2020-01-22
Brief Title:
Burn Out Among Medical Family Doctors
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Study of the Prevalence Risk Factors and Protective Factors of Burnout Among General Practitioners in France
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOUM
Brief 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
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
Detailed 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 JK et al Burnout in European family doctors the EGPRN study Family Practice 2008 254 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 p005 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 Fishers 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
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 JK et al Burnout in European family doctors the EGPRN study Family Practice 2008 254 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 p005 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 Fishers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None