NCT04129632

Brief Summary

: The problem of physician burnout has been well documented. As health care providers (HCP) encounter the demands and resources of a rapidly changing health care system, navigate their place and performance within it, deal with the demands of an internet informed patient populace and balance daily work load with family life, stressors arise. These stressors can contribute to burnout and this burnout has both interpersonal and health care system wide effects. Studies have shown that HCP burnout has personal physiologic consequences and predicts external objective associations with health care acquired infection rates, medical errors, medical litigation, patient satisfaction, job satisfaction, health care system costs, alcohol abuse and suicidal ideation, among others. As our population ages and its medical co-morbidities and system demands increase, the premature curtailing, cessation or turnover of an HCP's clinical practice due to emotional exhaustion is a concerning trend. While studies have shown that HCP's are no more prone to burnout then other professionals, a growing body of literature has shown that an intentional focus on institutional processes that nurture clinician well-being through multiple modalities is both important and effective. Additionally, insights into the role that forgiveness plays in personal well-being prompts our presentation of a novel mindfulness tool that focuses on improving clinician well-being through self-help exercises in meditation and forgiveness. In light of recent studies that have cautioned against the tendency to dichotomize and/or pathologize peoples' responses to their work environment, we will use the JD-R (Job demands-resources model) and the CBI (Copenhagen burnout inventory) to quantify these processes and responses. These factors have prompted us to present a unique study design a) to evaluate the wellness process affecters inside the culture of a regional health care center and b) to evaluate the effectiveness of a personal mindfulness intervention which aims at spectrum based burnout quantification and facilitated self-help, with an eye on both for institution wide application.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

October 15, 2019

Last Update Submit

November 12, 2020

Conditions

Keywords

burnoutwellnessmindfulnessphysician burnout

Outcome Measures

Primary Outcomes (1)

  • Copenhagen Burnout Inventory score

    A numerical quantification of burnout in health care providers with and without intervention. 19 questions, 1-5 scale, 19-95 total score, higher is worse/more burnout

    6 months

Study Arms (1)

IEPF intervention

OTHER

Survey respondent voluntary decides to do a 4 weeks mindfulness intervention

Behavioral: IEPF Wellness Tool

Interventions

A daily 5 minute mindfulness exercise over 28 days

Also known as: Insights and Exercises in Personal Forgiveness from Psalm 19
IEPF intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DO's, MD's, MA's, NP's, PA's, RN's, PharmD's

You may not qualify if:

  • any one not in the above professional categories

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkview Medical Center

Pueblo, Colorado, 81003, United States

Location

Related Publications (22)

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    PMID: 28900385BACKGROUND
  • Shanafelt TD, Noseworthy JH. Executive Leadership and Physician Well-being: Nine Organizational Strategies to Promote Engagement and Reduce Burnout. Mayo Clin Proc. 2017 Jan;92(1):129-146. doi: 10.1016/j.mayocp.2016.10.004. Epub 2016 Nov 18.

    PMID: 27871627BACKGROUND
  • Rotenstein LS, Torre M, Ramos MA, Rosales RC, Guille C, Sen S, Mata DA. Prevalence of Burnout Among Physicians: A Systematic Review. JAMA. 2018 Sep 18;320(11):1131-1150. doi: 10.1001/jama.2018.12777.

    PMID: 30326495BACKGROUND
  • Dyrbye et al., Burnout Among Health Care Professionals, A Call to Explore and Address This Under recognized Threat to Safe, High-Quality Care. NAM Perspectives. Discussion Paper, National Academy of Medicine.

    BACKGROUND
  • Henry JP. Biological basis of the stress response. Integr Physiol Behav Sci. 1992 Jan-Mar;27(1):66-83. doi: 10.1007/BF02691093.

    PMID: 1576090BACKGROUND
  • McEwen BS. Neurobiological and Systemic Effects of Chronic Stress. Chronic Stress (Thousand Oaks). 2017 Jan-Dec;1:2470547017692328. doi: 10.1177/2470547017692328. Epub 2017 Apr 10.

    PMID: 28856337BACKGROUND
  • McEwen BS. Protective and damaging effects of stress mediators. N Engl J Med. 1998 Jan 15;338(3):171-9. doi: 10.1056/NEJM199801153380307. No abstract available.

    PMID: 9428819BACKGROUND
  • Health, US report, 2016, CDC.

    BACKGROUND
  • Silver MP, Hamilton AD, Biswas A, Warrick NI. A systematic review of physician retirement planning. Hum Resour Health. 2016 Nov 15;14(1):67. doi: 10.1186/s12960-016-0166-z.

    PMID: 27846852BACKGROUND
  • Julkunen J, Salonen R, Kaplan GA, Chesney MA, Salonen JT. Hostility and the progression of carotid atherosclerosis. Psychosom Med. 1994 Nov-Dec;56(6):519-25. doi: 10.1097/00006842-199411000-00007.

    PMID: 7871107BACKGROUND
  • Cavanagh K, Strauss C, Forder L, Jones F. Can mindfulness and acceptance be learnt by self-help?: a systematic review and meta-analysis of mindfulness and acceptance-based self-help interventions. Clin Psychol Rev. 2014 Mar;34(2):118-29. doi: 10.1016/j.cpr.2014.01.001. Epub 2014 Jan 10.

    PMID: 24487343BACKGROUND
  • Harris, Alex HS., et al, Forgiveness, Unforgiveness, Health and Disease from Handbook of Forgiveness 2005, Routledge, Everett L. Worthington, ed.

    BACKGROUND
  • Thoresen, CE., et al, Effects of Forgiveness Intervention on perceived stress, state and trait anger and self-reported health. Paper presented at annual meeting for society of behavioral health, Seattle WA, 2001.

    BACKGROUND
  • Waltman, MA., The psychological and physiological effects of forgiveness education in male patients with coronary artery disease. Dissertation Abstracts International: Section B: The Sciences and Engineering; 63(8-B), 3971.

    BACKGROUND
  • Witvleit, C., forgiveness and Health: Review and reflections on a matter of faith, feelings and physiology, Journal of Psychology and Theology, 29, 212-224.

    BACKGROUND
  • Witvleit, C., et al., Please forgive me: Transgressors' emotions and physiology during imagery of seeking forgiveness and victim responses. Journal of Psychology and Christianity, 21, 219-233.

    BACKGROUND
  • vanOyen Witvliet C, Ludwig TE, Vander Laan KL. Granting forgiveness or harboring grudges: implications for emotion, physiology, and health. Psychol Sci. 2001 Mar;12(2):117-23. doi: 10.1111/1467-9280.00320.

    PMID: 11340919BACKGROUND
  • Worthington EL Jr, Witvliet CV, Pietrini P, Miller AJ. Forgiveness, health, and well-being: a review of evidence for emotional versus decisional forgiveness, dispositional forgivingness, and reduced unforgiveness. J Behav Med. 2007 Aug;30(4):291-302. doi: 10.1007/s10865-007-9105-8. Epub 2007 Apr 24.

    PMID: 17453329BACKGROUND
  • Lupano Perugini ML, de la Iglesia G, Castro Solano A, Keyes CL. The Mental Health Continuum-Short Form (MHC-SF) in the Argentinean Context: Confirmatory Factor Analysis and Measurement Invariance. Eur J Psychol. 2017 Mar 3;13(1):93-108. doi: 10.5964/ejop.v13i1.1163. eCollection 2017 Mar.

    PMID: 28344677BACKGROUND
  • The Copenhagen Burnout Inventory: A new tool for the assessment of burnout, Work and Stress 19(3): 192-207, July-September 2005

    BACKGROUND
  • Wohl, MMJA et al., Looking Within: Measuring State Self-Forgiveness and Its relationship to Psychological Well-Being. Canadian Journal of Behavioral Science 2008, Vol 40(1): 1-10.

    BACKGROUND
  • Bakker, A B et al., Using the jobs demands-resources model to predict burnout and performance. 2004 Human Resource Management, 43, 83-104.

    BACKGROUND

MeSH Terms

Conditions

Burnout, ProfessionalBurnout, Psychological

Interventions

Exercise

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Doug Duffee, MD

    Parkview Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No demographic linking to survey participants
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Cross sectional study design with intra cohort voluntary intervention participation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal Medicine Residency Faculty Attending Physician

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 17, 2019

Study Start

September 19, 2019

Primary Completion

September 30, 2020

Study Completion

October 30, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations