Evaluation of Institutional Resources and a Novel Mindfulness Tool on Burnout Intensity
NCT ID: NCT04129632
Last Updated: 2020-11-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
73 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-09-19
Study Completion Date
2020-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
: 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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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?
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?
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Burnout, Professional
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
burnout
wellness
mindfulness
physician burnout
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Cross sectional study design with intra cohort voluntary intervention participation
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
NONE
No demographic linking to survey participants
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IEPF intervention
Survey respondent voluntary decides to do a 4 weeks mindfulness intervention
Group Type
OTHER
IEPF Wellness Tool
Intervention Type
BEHAVIORAL
A daily 5 minute mindfulness exercise over 28 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IEPF Wellness Tool
A daily 5 minute mindfulness exercise over 28 days
Intervention Type
BEHAVIORAL
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Insights and Exercises in Personal Forgiveness from Psalm 19
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Parkview Medical Center
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Doug Duffee
Internal Medicine Residency Faculty Attending Physician
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Doug Duffee, MD
Role: PRINCIPAL_INVESTIGATOR
Parkview Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Parkview Medical Center
Pueblo, Colorado, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Henry JP. Biological basis of the stress response. Integr Physiol Behav Sci. 1992 Jan-Mar;27(1):66-83. doi: 10.1007/BF02691093.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Health, US report, 2016, CDC.
Reference Type
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Harris, Alex HS., et al, Forgiveness, Unforgiveness, Health and Disease from Handbook of Forgiveness 2005, Routledge, Everett L. Worthington, ed.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
The Copenhagen Burnout Inventory: A new tool for the assessment of burnout, Work and Stress 19(3): 192-207, July-September 2005
Reference Type
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.
Reference Type
BACKGROUND
Bakker, A B et al., Using the jobs demands-resources model to predict burnout and performance. 2004 Human Resource Management, 43, 83-104.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PIRB67
Identifier Type: -
Identifier Source: org_study_id