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

Burnout Syndrome Clinical Trial

— EDESPROAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870154
• Other study ID #: 08/1443
• Status: Completed
• Phase: N/A
• First received: June 2, 2013
• Last updated: June 4, 2013
• Start date: March 2010
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Burnout Syndrome

Intervention

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).

Locations

Country	Name	City	State
Spain	Gerencia de Atención Primaria	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid	Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maslach's burnout inventory (MBI)	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	One year	No
Secondary	Goldberg's General Health Questionnaire (GHQ-28)	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	No