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Early Detection of Burnout - Healthcare Workers

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ClinicalTrials.gov Identifier: NCT03881475
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
Burnout is a public health issue. Healthcare workers are particularly at risk of burnout with occupational stress identified as the major risk factor. The "Health Work Environment" service is composed of physicians, nurses and psychologist with the aim of providing efficient and adapted care for healthcare workers at CHU of Clermont-Ferrand. In addition, they must ensure a role of primary, secondary and tertiary prevention. With regard to burnout, the majority of the work carried out concerns tertiary prevention, that is to say the care of a person in a situation of burnout. It would be necessary to carry out secondary prevention in order that people at risk of burnout can be detected earlier. However, there is currently no individual questionnaire to detect early burnout

Condition or disease Intervention/treatment
Healthcare Workers Stress Occupation Other: questionnaire

Detailed Description:

Early detection of burnout was designed to provide a better understanding of warning sign of burnout in order to detect earlier workers at risk.

In the present protocol, parameters are measured on several occasions (0, 1 week, at 6 month, at 12 months and then at each occupational visit within 5 years).

Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be two-sided and p<0.05 will be considered significant. After testing for normal distribution (Shapiro-Wilk test), data will be treated either by parametric or non-parametric analyses according to statistical assumptions. Inter-groups comparisons will systematically be performed 1) without adjustment and 2) adjusting on factors liable to be biased between groups.

Analysis will be performed using anova or Kruskal-Wallis (KW) tests. When appropriate (p<0.05), a post-hoc test for multiple comparisons (Tukey-Kramer after anova and Dunn post KW) will be used.

Comparisions of categorical variables will be performed using Chi-squared or Fischer test. Marascuillo's procedure will be performed for multiple comparisons. Relations between quantitative outcomes will be analyzed using correlation coefficients (Pearson or Spearman). Fisher's Z transformation and William's T2 statistic will be performed to compare correlations between variables and within a single group of subjects. Longitudinal data will be treated using mixt-model analyses in order to treat fixed effects group, time and group x time interaction taking into account between and within participant variability.


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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of an Early Detection Questionnaire of Burnout in Healthcare Workers at Clermont-Ferrand University Hospital
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Group/Cohort Intervention/treatment
healthcare workers
Participants will participate in several sessions where they will complete the questionnaires. The questionnaires will be spaced: 0, 1 week, 6 months, 1 year and then at each occupational visit within 5 years.
Other: questionnaire

During consultations in occupational medicine (periodic visit and / or visit at the request of the employee), the nurses (or physicians) will propose the passation of the questionnaire to the voluntary agents.

The questionnaire, composed of 79 items with 2 validated questionnaires (HAD and MBI), will be filled using a digital tablet (via the REDCAP software).

Time required to complete the questionnaire 10 minutes.





Primary Outcome Measures :
  1. Level of burnout, anxiety and depression. [ Time Frame: at day 1 ]

    To assess the ability of a questionnaire of early detection of burnout, two validated questionnaires will be used: Maslach Burnout Inventory - Human Service Survey (in order to measure level of burnout) and Hospital Anxiety Depression Scale (in order to measure the presence of anxious or depressive symptoms).

    No other psychological or physiological measures will be taken.


  2. Level of anxiety [ Time Frame: at day 1 ]

    To assess the ability of a questionnaire of early detection of burnout, two validated questionnaires will be used: Maslach Burnout Inventory - Human Service Survey (in order to measure level of burnout) and Hospital Anxiety Depression Scale (in order to measure the presence of anxious or depressive symptoms).

    No other psychological or physiological measures will be taken.


  3. Level of depression [ Time Frame: at day 1 ]

    To assess the ability of a questionnaire of early detection of burnout, two validated questionnaires will be used: Maslach Burnout Inventory - Human Service Survey (in order to measure level of burnout) and Hospital Anxiety Depression Scale (in order to measure the presence of anxious or depressive symptoms).

    No other psychological or physiological measures will be taken.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthcare workers at Clermont-Ferrand Hospital
Criteria

Inclusion Criteria:

  • Healthcare workers at Clermont-Ferrand Hospital
  • Aged: from 18 years to retirement

Exclusion Criteria:

  • Participant refusal to participate
  • No healthcare workers at Clermont-Ferrand Hospital

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881475


Contacts
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Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
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France
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Frederic DUTHEIL         
Sub-Investigator: Denis PRUNET         
Sub-Investigator: Claire SEROLE         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Frederic DUTHEIL University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03881475     History of Changes
Other Study ID Numbers: CHU-432
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Burnout, Psychological
Stress, Psychological
Behavioral Symptoms