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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04129632
Other study ID # PIRB67
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 19, 2019
Est. completion date October 30, 2020

Study information

Verified date November 2020
Source Parkview Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Title: Evaluation of Institutional Job Demands-Resources and a Novel Mindfulness Tool on Burnout intensity in a Cross-Sectional Cohort of Colorado Health Care Practitioners Author: Doug Duffee MD, Mdiv, FACP, Attending Physician Parkview Internal Medicine Residency Program, Pueblo Colorado 2019 Intro: 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. Aims and Objectives: Using the Health Care Provider Wellness Assessment as quantified through the revised Job Demands-Resources Model (JD-R), the Copenhagen Burnout Inventory (CBI) (20)and a novel mindfulness tool called "Psalm 19: Insights and Exercises in Personal Forgiveness", we propose to 1) Identify unique institutional job demands-resources whose presence-absence contribute to HCP strain and subsequent health impairment and 2) Assess the ability of said novel mindfulness tool as a personal job resource component to positively affect well-being and subsequent job motivation amongst a cohort of Colorado health care providers at a regional medical center. As beneficial process effectors are identified (more/better/culturally focused resources, less/better efficiency demands) , multi-factorial interventions on wellness outcomes can subsequently be studied and implemented. Methods: Diagram Current Environment Wellness Process Wellness Outcomes - Health impairment process Job Demands + >Strain/burnout + >Health Problems l- /- l- \- l- Job Resources + >Well-being/engagement +>Performance - Motivational process 1. Design: Single blinded cohort controlled Cross-sectional survey research design using the JD-R, CBI and Wellness Tool to determine associations and affects on HCP burnout •identify cross-sectional intervention with survey cohort AND survey only control cohort>>>survey (with or without intervention) >>>analyze data 2. Population: Colorado health care clinicians (DO, MD, PA, NP, RN, PharmD and MA) at a single regional health care system (PMC) anonymously and voluntarily responding to the Parkview Medical Center Health Care Provider Wellness Assessment 3. Ethics: Blinded and voluntary participation Survey: Parkview Medical Center Health Care Provider Wellness Assessment 1. Parkview Medical Center Process Effectors (from JD-R revised): "on a scale of 1-5 (never/almost never, seldom, sometimes, often, always), rate your interaction with the following:" I. Job Demands: 1. Centralization 2. Cognitive demands 3. Complexity 4. Computer problems 5. Demanding contact with patients 6. Downsizing 7. Emotional demands 8. Emotional dissonance 9. Interpersonal conflict 10. Job insecurity 11. Negative spillover from family to work 12. Harassment by patients 13. Performance demands 14. Problems planning 15. Pupil's misbehavior 16. Qualitative workload 17. Reorganization 18. Remuneration 19. Responsibility 20. Risks and hazards 21. Role ambiguity 22. Role conflict 23. Sexual harassment 24. Time pressure 25. Unfavorable shift and work schedule 26. Unfavorable work conditions aa. Work pressure bb.Work-home conflict cc.Work overload II. Job Resources: a. Job based i. Advancement ii. Appreciation iii. Autonomy iv. Craftsmanship v. Financial rewards vi. Goal clarity vii. Information viii. Innovative climate ix. Job challenge x. Knowledge xi. Leadership xii. Opportunities for professional development xiii. Participation in decision making xiv. Performance feedback xv. Positive spillover from family to work xvi. Professional pride xvii. Procedural fairness xviii. Positive patient contacts xix. Quality of the relationship with the supervisor xx. Safety climate xxi. Safety routine violations xxii. Social climate xxiii. Social support from colleagues xxiv. Social support from supervisor xxv. Skill utilization xxvi. Strategic planning xxvii. Supervisory coaching xxviii. Task variety xxix. Team cohesion xxx. Team harmony xxxi. Trust in management b. Personal based i. Emotional and mental competencies ii. Extraversion iii. Hope iv. Intrinsic motivation v. Low neuroticisim vi. Need satisfaction (autonomy, belongingness, competence) vii. Optimism viii. Organization-based self esteem ix. Regulatory focus (prevention and promotion focus x. Resilience xi. Self-efficacy xii. Value orientation (intrinsic and extrinsic values) III. Measurement Outcomes, Negative (for future study, once process effectors are identified and intervened upon) 1. Absenteeism (self-report and company registered) 2. Accidents and injuries 3. Adverse events 4. Depression 5. Determination to continue 6. Unsafe behaviors 7. Negative work-home interference 8. Physical ill-health 9. Psychsomatic health complaints 10. Psychological strain (General Health Questionairre, GHQ) 11. Turnover intention IV. Measurement Outcomes, Positive (for future study, once process effectors are identified and intervened upon) 1. Extra-role performance (self or other rated) 2. Innovativeness 3. In-role performance (self or other rated) 4. Life satisfaction 5. Organizational commitment 6. Perceived health 7. Positive work-home interference 8. Service quality 9. Team sales performance 10. Workability 11. Happiness 2. Copenhagen Burnout Inventory: "on a scale of 1-5 (never/almost never, seldom, sometimes, often, always), rate your interaction with the following:" a. Personal burnout i. How often do you fell tired? ii. How often are you physically exhausted? iii. How often are you emotionally exhausted? iv. How often do you think: "I can't take it anymore"? v. How often do you feel worn out? vi. How often do you feel weak and susceptible to illness? b. Work-related burnout i. Is your work emotionally exhausting? ii. Do you feel burnt out because of your work? iii. Does your work frustrate you? iv. Do you feel worn out at the end of the working day? v. Are you exhausted in the morning at the thought of another day at work? vi. Do you feel that every working hour is tiring for you? vii. Do you have enough energy for family and friends during leisure time? (reverse the scoring: 1-5 is (always, often, sometimes, seldom, never/almost never) c. Client-related burnout i. Do you find it hard to work with clients? ii. Do you find it frustrating to work with clients? iii. Does it drain your energy to work with clients? iv. Do you feel that you give more than you get back when you work with clients? v. Are you tired of working with clients? vi. Do you sometimes wonder how long you will be able to continue working with clients?


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date October 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - DO's, MD's, MA's, NP's, PA's, RN's, PharmD's Exclusion Criteria: - any one not in the above professional categories

Study Design


Intervention

Behavioral:
IEPF Wellness Tool
A daily 5 minute mindfulness exercise over 28 days

Locations

Country Name City State
United States Parkview Medical Center Pueblo Colorado

Sponsors (1)

Lead Sponsor Collaborator
Parkview Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (22)

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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. Review. — View Citation

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.

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

Health, US report, 2016, CDC.

Henry JP. Biological basis of the stress response. Integr Physiol Behav Sci. 1992 Jan-Mar;27(1):66-83. Review. — View Citation

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. — View Citation

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. — View Citation

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

McEwen BS. Protective and damaging effects of stress mediators. N Engl J Med. 1998 Jan 15;338(3):171-9. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Silver MP, Hamilton AD, Biswas A, Warrick NI. A systematic review of physician retirement planning. Hum Resour Health. 2016 Nov 15;14(1):67. Review. — View Citation

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

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.

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. — View Citation

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.

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.

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

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.

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. Epub 2007 Apr 24. Review. — View Citation

Yaribeygi H, Panahi Y, Sahraei H, Johnston TP, Sahebkar A. The impact of stress on body function: A review. EXCLI J. 2017 Jul 21;16:1057-1072. doi: 10.17179/excli2017-480. eCollection 2017. Review. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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