Clinical trial NCT04336436: The Impact of Combined Mindfulness-Based Interventions and Nutritional Counseling on Physician Burnout
Official title: The Impact of Combined Mindfulness-Based Interventions and Nutritional Counseling on Physician Burnout: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive mindfulness based training and nutritional consultation.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

A second cluster of studies implemented lifestyle changes, more specifically, incentivized exercise programs and nutritional counseling for burnout. However, studies examining the effects of physical activity tended to be short in duration, of small magnitude, and lacked adequate assessment of the physiological and biochemical effects of exercise on burnout \[23\]. Additionally, a significant lack of research on nutritional and dietary interventions in physician burnout exist in the literature, despite the vitality of good nutrition in the health and wellbeing of physicians.

Therefore, this study intends 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 effects of the interventions will be evaluated through assessment of changes in physiological and biochemical parameters known to be adversely affected in burnout, in addition to the standardized Professional Fulfillment Inventory, at 3-6 months post-intervention.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Professional Fulfillment Index (PFI) score
timeFrame: 3-6 months
measure: Change in Neff Self-Compassion Scale score
timeFrame: 3-6 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 3-6 months
measure: Resting heart rate
timeFrame: 3-6 months
measure: Weight
timeFrame: 3-6 months
measure: Athens Insomnia Scale
timeFrame: 3-6 months
measure: Daily average time spent reviewing electronic health records
timeFrame: 3-6 months
measure: Total Cholesterol
timeFrame: 3-6 months
measure: Hemoglobin A1c
timeFrame: 3-6 months
measure: Fasting plasma glucose
timeFrame: 3-6 months
measure: Fasting insulin
timeFrame: 3-6 months
measure: C-reactive protein
timeFrame: 3-6 months
measure: Insulin Resistance
timeFrame: 3-6 months
measure: High density lipoprotein (HDL)
timeFrame: 3-6 months
measure: Low density lipoprotein (LDL)
timeFrame: 3-6 months
measure: Triglycerides
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Staff Physician
name: Betul Hatipoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahola K, Hakanen J. Job strain, burnout, and depressive symptoms: a prospective study among dentists. J Affect Disord. 2007 Dec;104(1-3):103-10. doi: 10.1016/j.jad.2007.03.004. Epub 2007 Apr 19.
citation: Fred HL, Scheid MS. Physician Burnout: Causes, Consequences, and (?) Cures. Tex Heart Inst J. 2018 Aug 1;45(4):198-202. doi: 10.14503/THIJ-18-6842. eCollection 2018 Aug. No abstract available.
citation: Rothenberger DA. Physician Burnout and Well-Being: A Systematic Review and Framework for Action. Dis Colon Rectum. 2017 Jun;60(6):567-576. doi: 10.1097/DCR.0000000000000844.
citation: Pantenburg B, Luppa M, Konig HH, Riedel-Heller SG. Burnout among young physicians and its association with physicians' wishes to leave: results of a survey in Saxony, Germany. J Occup Med Toxicol. 2016 Jan 22;11:2. doi: 10.1186/s12995-016-0091-z. eCollection 2016.
citation: Dyrbye L, Shanafelt T. A narrative review on burnout experienced by medical students and residents. Med Educ. 2016 Jan;50(1):132-49. doi: 10.1111/medu.12927.