NCT04625582

Brief Summary

BACKGROUND The burnout syndrome among health care workers frequently rises to prevalence above 50%. One of the consequences most supported by the literature is the impoverishment of the therapeutic alliance, triggered by a loss of empathy of the clinician towards the patient due to the emotional exhaustion he or she suffers. The main factors that influence the presence of this pathology are stressors related to the organization of work. However, this equation is also influenced by individual factors that can be acted upon and which are often the only tools available for professionals. Due to the widely supported relationship of empathy, burnout and therapeutic alliance, the investigators decided to carry out a complex training plan focused on personal development in teaching units of Family and Community Care in Spain. RESEARCH QUESTION Is effective an intervention aimed to promoting the development of personal skills throughout the training of family and community care doctors and nurses? METHOD Pre-post study, comparing two educational interventions, one face-to-face (N=90) and other online (N=70), with a control group (N=170). Participants: All physicians and nurse trainees on Primary Health Care in three Spanish Health Regions who wish to participate in the study. The face-to-face intervention consists of 3 annual workshops, while the online one will be carried out by adapting the theoretical contents of the face-to-face intervention for online use and will pursue the same objectives and be fed by the same contents. The variation in the level of empathy will be quantified by means of the Interpersonal Reactivity Index (IRI) questionnaire, adjusted by burnout (Copenhagen questionnaire) and other variables such as resilience (Connor-Davidson), locus of control, social support (Oslo-3), sense of coherence (OLQ-13), age, sex, personality (Ten Item Personality Inventory, TIPI-SP) and other organisational factors. Statistical analysis with generalized lineal models and generalized additive models.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

November 6, 2020

Last Update Submit

November 10, 2020

Conditions

Keywords

Intervention studyFamily Medicine traineesCommunity Nursing trainees

Outcome Measures

Primary Outcomes (1)

  • Self-rated empathy

    Interpersonal Reactivity Index, with four subscales, scores range from 0 to 28 in each one

    Two years

Secondary Outcomes (1)

  • Self-rated burnout

    Two years

Study Arms (3)

Face-to-face intervention

EXPERIMENTAL

90 trainees at Vigo Family Medicine and Community Nursing Training Unit

Behavioral: Face-to-face

Online intervention

EXPERIMENTAL

70 trainees at Aragón Family Medicine and Community Nursing Training Unit

Behavioral: Online

Usual training

NO INTERVENTION

180 trainees at Balearic Islands Family Medicine and Community Nursing Training Unit

Interventions

Face-to-faceBEHAVIORAL

The intervention has been created specifically for this group of trainees, with the aim of acquiring or improving mediating personal skills in the processes of physical and mental well-being that help them cope with more motivation, enthusiasm and personal resources professional challenges. It is based on conducting 4-hour face-to-face workshops, every four months throughout the period of specialized health training. They will be instrumented through group dynamics, communication exercises, leadership, corporality, and reflective and emotional writing. Audiovisual media (videos, presentations, recordings) will be used. They will be developed in person in a classroom equipped with the necessary means for training, including versatility of the space.

Face-to-face intervention
OnlineBEHAVIORAL

The online intervention will pursue the same objectives and will be nourished by the same content as the face-to-face intervention. The theoretical content will be adapted for online use, with the flexibility of access and organization that this entails for the participants, including videos, presentations, recordings ... Group techniques will be carried out online, every four months during the entire period of specialized health professional training. They will be instrumented through group dynamics, communication exercises, leadership, corporality, and reflective and emotional writing.

Online intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Residents (doctors and nurses) of the three Family Medicine and Community Nursing Training Units
  • From the 2018, 2019, 2020 and 2021 promotions
  • Who want to participate in the study and signed informed consent.

You may not qualify if:

  • Residents who refuse to participate and / or do not sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ana Clavería

Vigo, 36201, Spain

RECRUITING

MeSH Terms

Conditions

Burnout, Professional

Interventions

Pharmaceutical Services, Online

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Pharmaceutical ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ana Clavería, MD, PhD, MPH

    Sergas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Clavería, MD, PhD, MPH

CONTACT

Sabela Couso, Nurse. MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: Ante-post evaluation study of the effectiveness of an educational intervention to improve empathy, with three arms: face-to-face, online and control group, lasting 2 years. The intervention is organized during the training of residents of Family Medicine and Community Nursing in three teaching units in different Spanish Health Authorities.
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 12, 2020

Study Start

November 6, 2020

Primary Completion

November 1, 2022

Study Completion

May 1, 2023

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
2023 to 2025
Access Criteria
Under request

Locations