search
Back to results

The Impact of Combined Mindfulness-Based Interventions and Nutritional Counseling on Physician Burnout

Primary Purpose

Burnout, Professional

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness training
Nutritional consult
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burnout, Professional

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness Training and Nutrition Counseling

Arm Description

Baseline and 3-6 month follow up visits will be arranged for all participants. Visits will be conducted at baseline prior to initiation of mindfulness training and nutrition counseling, and at the 3-6 month follow up. Clinical and laboratory assessments will be obtained at each visit.

Outcomes

Primary Outcome Measures

Change in Professional Fulfillment Index (PFI) score
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
Measured at baseline and at 3-6 months for each participant to determine if intervention was effective. A higher score indicates improvement.

Secondary Outcome Measures

Blood pressure
Change in diastolic and systolic blood pressure between baseline and 3-6 months after intervention
Resting heart rate
Change in resting heart rate between baseline and 3-6 months after intervention
Weight
Change in weight between baseline and 3-6 months after intervention
Athens Insomnia Scale
Change in insomnia scale between baseline and 3-6 months after intervention. Range from 0-24 with lower score being favorable outcome.
Daily average time spent reviewing electronic health records
Self reported time spent (in hours) reviewing electronic health records
Total Cholesterol
Change in total cholesterol post-intervention
Hemoglobin A1c
Change in HbA1c post-intervention
Fasting plasma glucose
Change in fasting plasma glucose post-intervention
Fasting insulin
Change in fasting insulin value post-intervention
C-reactive protein
Change in C-reactive protein levels post-intervention
Insulin Resistance
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) to assess presence of and extent of insulin resistance
High density lipoprotein (HDL)
Change in HDL value post-intervention
Low density lipoprotein (LDL)
Change in LDL value post-intervention
Triglycerides
Change in triglycerides post-intervention

Full Information

First Posted
April 3, 2020
Last Updated
January 5, 2021
Sponsor
The Cleveland Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT04336436
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive mindfulness based training and nutritional consultation.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Training and Nutrition Counseling
Arm Type
Experimental
Arm Description
Baseline and 3-6 month follow up visits will be arranged for all participants. Visits will be conducted at baseline prior to initiation of mindfulness training and nutrition counseling, and at the 3-6 month follow up. Clinical and laboratory assessments will be obtained at each visit.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness training
Intervention Description
Mindfulness training
Intervention Type
Behavioral
Intervention Name(s)
Nutritional consult
Intervention Description
Nutrition counseling and development of a personalized nutrition plan
Primary Outcome Measure Information:
Title
Change in Professional Fulfillment Index (PFI) score
Description
Measured at baseline and at 3-6 months for each participant to determine if intervention was effective. A higher score indicates improvement.
Time Frame
3-6 months
Title
Change in Neff Self-Compassion Scale score
Description
Measured at baseline and at 3-6 months for each participant to determine if intervention was effective. A higher score indicates improvement.
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Change in diastolic and systolic blood pressure between baseline and 3-6 months after intervention
Time Frame
3-6 months
Title
Resting heart rate
Description
Change in resting heart rate between baseline and 3-6 months after intervention
Time Frame
3-6 months
Title
Weight
Description
Change in weight between baseline and 3-6 months after intervention
Time Frame
3-6 months
Title
Athens Insomnia Scale
Description
Change in insomnia scale between baseline and 3-6 months after intervention. Range from 0-24 with lower score being favorable outcome.
Time Frame
3-6 months
Title
Daily average time spent reviewing electronic health records
Description
Self reported time spent (in hours) reviewing electronic health records
Time Frame
3-6 months
Title
Total Cholesterol
Description
Change in total cholesterol post-intervention
Time Frame
3-6 months
Title
Hemoglobin A1c
Description
Change in HbA1c post-intervention
Time Frame
3-6 months
Title
Fasting plasma glucose
Description
Change in fasting plasma glucose post-intervention
Time Frame
3-6 months
Title
Fasting insulin
Description
Change in fasting insulin value post-intervention
Time Frame
3-6 months
Title
C-reactive protein
Description
Change in C-reactive protein levels post-intervention
Time Frame
3-6 months
Title
Insulin Resistance
Description
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) to assess presence of and extent of insulin resistance
Time Frame
3-6 months
Title
High density lipoprotein (HDL)
Description
Change in HDL value post-intervention
Time Frame
3-6 months
Title
Low density lipoprotein (LDL)
Description
Change in LDL value post-intervention
Time Frame
3-6 months
Title
Triglycerides
Description
Change in triglycerides post-intervention
Time Frame
3-6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betul Hatipoglu, MD
Organizational Affiliation
Staff Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17448543
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.
Results Reference
background
PubMed Identifier
30374225
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.
Results Reference
background
PubMed Identifier
28481850
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.
Results Reference
background
PubMed Identifier
26807138
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.
Results Reference
background
PubMed Identifier
26695473
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.
Results Reference
background

Learn more about this trial

The Impact of Combined Mindfulness-Based Interventions and Nutritional Counseling on Physician Burnout

We'll reach out to this number within 24 hrs