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

Sponsor
Gerencia de Atención Primaria, Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT01870154
Collaborator
Fondo de Investigacion Sanitaria (Other)
300
1
2
36
8.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Effectiveness of an Intervention for Prevention and Treatment of Burnout in Primary Health Care Professionals
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Maslach's burnout inventory (MBI) [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.

Secondary Outcome Measures

  1. Goldberg's General Health Questionnaire (GHQ-28) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gerencia de Atención Primaria Madrid Spain 28003

Sponsors and Collaborators

  • Gerencia de Atención Primaria, Madrid
  • Fondo de Investigacion Sanitaria

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier:
NCT01870154
Other Study ID Numbers:
  • 08/1443
First Posted:
Jun 5, 2013
Last Update Posted:
Jun 5, 2013
Last Verified:
Jun 1, 2013
Keywords provided by Gerencia de Atención Primaria, Madrid
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 5, 2013