Effectiveness of an Intervention for Prevention and Treatment of Burnout in Primary Care (EDESPROAP)

June 4, 2013 updated by: Gerencia de Atención Primaria, Madrid

Effectiveness of an Intervention for Prevention and Treatment of Burnout in Primary Health Care Professionals

Background: Burnout syndrome is an important health problem that affects many professionals and must be addressed globally, with both organizational measures and personal interventions. Burnout of health professionals can be prevented in order to avoid personal, familial, and social consequences, as well as repercussions for patients.

Methods/Design: This work describes a protocol for a controlled, pragmatic, randomized clinical trial in 2 parallel groups: intervention and control. All health professionals from 7 health care centers (HCCs) will form the intervention group, and all health professionals from 7 different HCCs will form the control group. The intervention group will receive 16 hours of training at their work place. The Maslach's burnout inventory (MBI), burnout physician Questionnaire (CDPM) or burnout nurse Questionnaire (CDPE), and the 28-item Goldberg's General Health Questionnaire (GHQ-28), validated for our setting, will be used as measurement tools. Change in the average scores from the MBI emotional exhaustion scale will be compared between the intervention and control groups, measured as intention-to-treat, and the intervention will be considered effective if a minimum increase of 20% is achieved.

Discussion: Due to the deleterious consequences of burnout syndrome for people suffering from it and for the organization where they work, it is necessary to evaluate the effectiveness of certain interventions for its prevention. Organizational measures are important for preventing burnout syndrome, but so is providing professionals with coping strategies, as this group intervention intends to do.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

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

  • Spain
      • Madrid, Spain, 28003
        • Gerencia de atención primaria

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All health professionals (family physicians, pediatricians, and nurses) who are part of the health care centers at the moment of the trial.

Exclusion Criteria:

  • No one.

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
The intervention consists of 16 hours of training, to be held at the subject's health center. The workshop involves mixed learning, comprising 4 sessions, each 2 hours long, in addition to personal work previous to and after each session of reading relevant bibliography and performing exercises, self-evaluation, and case studies (8 hours of individual work).
Behavioral: Training
The objective of the intervention is learning from the work experience of professionals attending the workshop to know and recognize the risk and process of the burnout syndrome and the characteristics specific to the health setting, as well as promoting prevention lines by transmitting strategies to manage and control the elements and consequences of the syndrome process (physical, psychological, and social).
ACTIVE_COMPARATOR: Control group
Usual care
Behavioral: Training
The objective of the intervention is learning from the work experience of professionals attending the workshop to know and recognize the risk and process of the burnout syndrome and the characteristics specific to the health setting, as well as promoting prevention lines by transmitting strategies to manage and control the elements and consequences of the syndrome process (physical, psychological, and social).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maslach's burnout inventory (MBI)
Time Frame: One year
Worker classification regarding burnout syndrome will be performed according to the MBI, which includes 22 items to evaluate emotional exhaustion (EE), depersonalization (DP), and personal fulfillment (PF), with scores ranging from 0 to 6 on the Likert scale. We consider a high degree of burnout in the case of EE ≥ 27 points, DP ≥ 10, and PF <33. Moderate burnout will be considered in the case of 26<EE<19 points, 6<DP<9 points, and 34<PF<39 points. Low levels will be considered for EE≤18 points, DP≤5 points, and PF≥40 points.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goldberg's General Health Questionnaire (GHQ-28)
Time Frame: One year
It consists of 28 items, divided into 4 sub-scales. It is used to estimate the prevalence of psychiatric disease in a specific population and discover cases of psychiatric pathologies in non specialized consultations. It is not appropriate for performing clinical diagnosis, but can be employed to evaluate symptomatology using its sub-scales: A (somatic symptoms), B (anxiety/insomnia), C (social dysfunction), and D (severe depression). There are 4 possible answers to each question. The Likert scoring system assigns a value from 0 to 3 to each of the 4 possible answers.
One year

Collaborators and Investigators

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

Sponsor

Gerencia de Atención Primaria, Madrid

Collaborators

Fondo de Investigacion Sanitaria

Investigators

  • Principal Investigator: Tomás Gómez-Gascón, MD, Gerencia de Atención Primaria, Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2010

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

June 2, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (ESTIMATE)

June 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/1443

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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