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临床试验/NCT04336436
NCT04336436已完成不适用

The Impact of Combined Mindfulness-Based Interventions and Nutritional Counseling on Physician Burnout: A Clinical Trial

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Change in Professional Fulfillment Index (PFI) score

研究概览

简要总结

This study is designed to tackle the issue of physician burnout via a wide-lens approach, integrating both mindfulness-based training and nutritional counseling in the management of professional burnout. The investigators will evaluate the effects of mindfulness training and nutritional counseling interventions through assessment of changes in physiological and biochemical parameters known to be adversely affected in burnout, in addition to the standardized Professional Fulfillment inventory scores at 3-6 months post-intervention.

详细描述

There is a preponderance of data to support the detrimental effects of burnout on physicians' health and wellbeing. Physician burnout is defined as severe emotional exhaustion, depersonalization towards others and reduced sense of personal achievement. Burnout is often accompanied by feelings of moral distress, loss of interest and energy, and detachment from patients, colleagues and personal relatives. With the recent rapid expansion in global healthcare systems in response to societal changes, rates of physician burnout have been on the rise. It is estimated that 54% of physicians in the United States suffer from professional burnout, a 2-fold higher prevalence than that estimated for the general working population of 28%.

Burnout has serious negative implications on the physical health and wellbeing of individuals. In recent studies, burnout was associated with higher incidence of coronary heart disease and hospitalization from cardiovascular causes. Additionally, burnout was found to be an independent risk factor for type 2 diabetes mellitus and hypercholesterolemia (total cholesterol ≥220 mg/dl). Higher incidence of musculoskeletal pain and pain-related disability were also reported amongst subjects with high burnout. Excessive fatigue, insomnia, headaches, gastrointestinal and respiratory issues were all positively correlated with burnout level. More strikingly, burnout was found to be a significant predictor of mortality in those below the age of 45-years.

Burnout carries its repercussions on mental health as well. In a study of 2,555 dentists, burnout was a significant predictor of depression occurrence during the 3-year follow-up period. Increased psychotropic and antidepressant use was associated with high burnout, with a stronger correlation observed for men than women. High level of burnout was also linked to increased risk of anxiety, substance abuse, alcohol abuse, and even suicidal ideation.

Burnout is a serious threat to the medical profession at large. With more than half of the US physicians suffering from professional burnout, its implications ripple through the entirety of the healthcare system. Burnout decreases both patient care quality and physician productivity. Increased sickness absences have been reported in high burnout. In a recent report, severe burnout independently accounted for 52 sickness absences in a 2-year follow-up period. Additionally, burnout has resulted in more physicians leaving practices or reducing their work hours. A healthcare system loses on average $500,000 to $1,000,000 with the departure of a physician, in addition to the ever-increasing workload of physicians who remain in practice. Most significant of all, burnout leads to major medical errors. With the estimated 250,000 deaths in the United States occurring due to medical errors, developing effective strategies to eliminate physician burnout has become an ever-present priority.

A number of prospective studies and clinical trials have been conducted to assess the efficacy of different interventions on mitigating physician burnout. A major cluster of these studies have focused on behavioral interventions, more specifically, mindfulness-based approaches aimed at reducing the mental and emotional repercussions of burnout. Such behavioral interventions included practices of contemplation-meditation exercises, discussions on enhancing self-care and intensification of present-moment awareness. Efficacy in the latter studies was mostly assessed via quantification of change in burnout and stress-related scores, most notably the Maslach Burnout Inventory score, a well-established tool for assessment of burnout in the occupational setting. The majority of these studies reported favorable effects on burnout scores. However, limited to no-data exist on the physiological and biochemical effects of mindfulness-based interventions on physician burnout.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Physician employed by Cleveland Clinic
  • Located in Ohio
  • Must anticipate remaining employed for at least 6 months post-enrollment

排除标准

  • Non-MD or non-DO healthcare providers
  • Unable to commit to intervention sessions
  • Current diagnosis of uncontrolled hypertension, and/or uncontrolled diabetes mellitus (defined as hemoglobin A1c ≥9%)
  • Current or previous history of Cushing's disease or pheochromocytoma/paraganglioma

结局指标

主要结局

Change in Professional Fulfillment Index (PFI) score

时间窗: 3-6 months

Measured at baseline and at 3-6 months for each participant to determine if intervention was effective. A higher score indicates improvement.

Change in Neff Self-Compassion Scale score

时间窗: 3-6 months

Measured at baseline and at 3-6 months for each participant to determine if intervention was effective. A higher score indicates improvement.

次要结局

  • Athens Insomnia Scale(3-6 months)
  • C-reactive protein(3-6 months)
  • High density lipoprotein (HDL)(3-6 months)
  • Fasting insulin(3-6 months)
  • Insulin Resistance(3-6 months)
  • Triglycerides(3-6 months)
  • Fasting plasma glucose(3-6 months)
  • Blood pressure(3-6 months)
  • Daily average time spent reviewing electronic health records(3-6 months)
  • Total Cholesterol(3-6 months)
  • Resting heart rate(3-6 months)
  • Weight(3-6 months)
  • Hemoglobin A1c(3-6 months)
  • Low density lipoprotein (LDL)(3-6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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