Early Detection of Burnout - Healthcare Workers

March 18, 2019 updated by: University Hospital, Clermont-Ferrand

Validation of an Early Detection Questionnaire of Burnout in Healthcare Workers at Clermont-Ferrand University Hospital

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

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Chu Clermont-Ferrand
        • Sub-Investigator:
          • Denis PRUNET
        • Sub-Investigator:
          • Claire SEROLE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthcare workers at Clermont-Ferrand Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

at day 1
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.

at day 1
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.

at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ANTICIPATED)

June 30, 2019

Study Completion (ANTICIPATED)

June 30, 2020

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (ACTUAL)

March 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CHU-432

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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