跳至主要内容
临床试验/NCT04625582
NCT04625582Unknown不适用

Modeling and Effectiveness of an Educational Intervention for the Development of Professional Skills in Family Medicine and Community Nurses Residents (PROEMPATIA)

Galician South Health Research Institute1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2020年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
340
试验地点
1
主要终点
Self-rated empathy

研究概览

简要总结

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.

详细描述

With the purpose of modeling and evaluating a comprehensive personal development intervention in family and community care residents (doctors and nurses) this project is proposed. With two expected results from the professionals' perspective: first, to evaluate the changes in self-perceived empathy; on the other hand, the modification of the level of exhaustion in them. In both, taking into account the personal factors discussed above, as well as organizational or training factors during this period of the residents' lives.

In essence, our model assumes that personal (on which the intervention will act) and organizational factors modulate changes in the exhaustion of residents during their residence. In turn, the differences in professional burnout will be reflected in self-perceived empathy at the end of the study.

Due to the novelty and curricular changes that its implementation would entail, the investigators want to quantify its effectiveness in the results sought, comparing the effectiveness of a face-to-face intervention, an online intervention with the same objectives and content, and a control group.

HYPOTHESIS:

  1. Mean self-perceived empathy will increase at least 1 point in the face-to-face intervention group compared to the control group.
  2. The professional burnout syndrome of the participants will be 10% lower in the face-to-face intervention group at the end of the study compared to the control group.
  3. Personal skills (greater empathy, greater sense of coherence, greater resilience, internal locus of control, greater social support), will be independently inversely associated with the burnout syndrome, adjusting for personal factors (younger age, male sex, positive personality traits), organizational (less workload), training (greater adherence to the intervention, greater participation in other activities related to it) and by the participant's baseline anxiety and depression.
  4. Face-to-face intervention will improve self-perceived empathy and decrease burnout syndrome better than online; these differences will be significant.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

Face-to-face intervention

Experimental

90 trainees at Vigo Family Medicine and Community Nursing Training Unit

干预措施: Face-to-face (Behavioral)

Online intervention

Experimental

70 trainees at Aragón Family Medicine and Community Nursing Training Unit

干预措施: Online (Behavioral)

Usual training

No Intervention

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

结局指标

主要结局

Self-rated empathy

时间窗: Two years

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

次要结局

  • Self-rated burnout(Two years)

研究者

发起方
Galician South Health Research Institute
申办方类型
Network
责任方
Sponsor

研究点 (1)

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