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Burnout, ProfessionalNCT04129632

Evaluation of Institutional Resources and a Novel Mindfulness Tool on Burnout Intensity

A study testing IEPF Wellness Tool in people with Burnout, Professional, run by Parkview Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Burnout, Professional
What is being tested?
IEPF Wellness Tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteUnited States
Study dates
19 Sep 2019to 30 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • any one not in the above professional categories

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Parkview Medical Center

    Pueblo, Colorado, 81003

Other trials in United States

About this study

Official 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

: 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.

Read the detailed 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:"
  2. Job Demands:
  3. Centralization
  4. Cognitive demands
  5. Complexity
  6. Computer problems
  7. Demanding contact with patients
  8. Downsizing
  9. Emotional demands
  10. Emotional dissonance
  11. Interpersonal conflict
  12. Job insecurity
  13. Negative spillover from family to work
  14. Harassment by patients
  15. Performance demands
  16. Problems planning
  17. Pupil's misbehavior
  18. Qualitative workload
  19. Reorganization
  20. Remuneration
  21. Responsibility
  22. Risks and hazards
  23. Role ambiguity
  24. Role conflict
  25. Sexual harassment
  26. Time pressure
  27. Unfavorable shift and work schedule
  28. Unfavorable work conditions aa. Work pressure bb.Work-home conflict cc.Work overload II. Job Resources:
  29. 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)
  30. Absenteeism (self-report and company registered)
  31. Accidents and injuries
  32. Adverse events
  33. Depression
  34. Determination to continue
  35. Unsafe behaviors
  36. Negative work-home interference
  37. Physical ill-health
  38. Psychsomatic health complaints
  39. Psychological strain (General Health Questionairre, GHQ)
  40. Turnover intention IV. Measurement Outcomes, Positive (for future study, once process effectors are identified and intervened upon) <!-- -->
  41. Extra-role performance (self or other rated)
  42. Innovativeness
  43. In-role performance (self or other rated)
  44. Life satisfaction
  45. Organizational commitment
  46. Perceived health
  47. Positive work-home interference
  48. Service quality
  49. Team sales performance
  50. Workability
  51. Happiness
  52. 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?
Being tested
IEPF Wellness Tool
Keywords
burnout, wellness, mindfulness, physician burnout
Medical subject headings
Burnout, Professional, Burnout, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IEPF Wellness ToolBehavioural

    Also called Insights and Exercises in Personal Forgiveness from Psalm 19

    A daily 5 minute mindfulness exercise over 28 days

Study groups in NCT04129632
Study groupRoleWhat they receive
IEPF interventionOtherSurvey respondent voluntary decides to do a 4 weeks mindfulness intervention
Receives: Behavioral: IEPF Wellness Tool

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2019
  2. Study start19 Sep 2019
  3. Primary completion30 Sep 2020
  4. Study completion30 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Cross sectional study design with intra cohort voluntary intervention participation
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04129632
Sponsor's protocol ID
PIRB67
Status last verified
Nov 2020
First submitted
15 Oct 2019
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28900385
  • 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.

    PubMed 27871627
  • 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.

    PubMed 30326495
  • 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.

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

    PubMed 1576090
  • 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.

    PubMed 28856337
  • 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.

    PubMed 9428819
  • Health, US report, 2016, CDC.

  • 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.

    PubMed 27846852
  • 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.

    PubMed 7871107
  • 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.

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

  • 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.

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

Questions about this trial

What is this clinical trial studying?

A study testing IEPF Wellness Tool in people with Burnout, Professional, run by Parkview Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Copenhagen Burnout Inventory score (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04129632, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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