NCT03413969

Brief Summary

The purpose of this study is to determine whether a standardized application of a physician-oriented CREATION Health curriculum is associated with reductions in burnout and perceived stress and improvements in well-being and empathy

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

January 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2019

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

January 23, 2018

Last Update Submit

March 28, 2019

Conditions

BurnoutStressWell-being

Outcome Measures

Primary Outcomes (1)

  • Maslach Burnout Inventory - Human Services Survey

    The Emotional Exhaustion subscale scores range from 0 to 54. Higher scores indicate worse outcomes. The Depersonalization subscale scores range from 0 to 30. Higher scores indicate worst outcomes. The Personal Accomplishment subscale scores range from 0 to 48. Higher scores indicate better outcomes.

    12 Months

Secondary Outcomes (1)

  • Well-Being Item

    12 Months

Other Outcomes (2)

  • Perceived Stress Scale

    12 Months

  • Jefferson Scale of Empathy

    12 Months

Study Arms (1)

Behavioral Intervention

EXPERIMENTAL

The study subjects will be recruited for approximately six weeks prior to the projected start date. The participants will attend the two-day weekend retreat. Follow-up assessments will be administered three months and six months after the retreat. The investigators will analyze the data and complete the study one month after the final assessment is administered.

Behavioral: CREATION

Interventions

CREATIONBEHAVIORAL

The physician-oriented intervention will consist of a two-day weekend retreat that focuses on the application of CREATION Health principles in order to reduce burnout and perceived stress and improve well-being and empathy. There will be one four-hour session about each of the following CREATION Health principles: Choice, Trust, Interpersonal Relationships, and Outlook.

Behavioral Intervention

Eligibility Criteria

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

You may qualify if:

  • Physician employed by Centura Health or credentialed physician with privileges at Centura Health
  • Adult ≥ 18 years old
  • English language proficiency
  • Able to provide informed consent
  • Resides in the Denver, Colorado area
  • Willing to commit to the timeline of the study

You may not qualify if:

  • Plans to reside outside of the Denver, Colorado area within the 8 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Hospital

Orlando, Florida, 32804, United States

Location

Related Publications (25)

  • Shanafelt TD, Boone S, Tan L, Dyrbye LN, Sotile W, Satele D, West CP, Sloan J, Oreskovich MR. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med. 2012 Oct 8;172(18):1377-85. doi: 10.1001/archinternmed.2012.3199.

    PMID: 22911330BACKGROUND

  • Maslach C, Jackson SE, Leiter MP. Maslach Burnout Inventory manual. 3rd ed. Palo Alto, CA: Consulting Psychologists Press; 1996.

    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.

    PMID: 27871627BACKGROUND

  • Shanafelt TD, Sloan JA, Habermann TM. The well-being of physicians. Am J Med. 2003 Apr 15;114(6):513-9. doi: 10.1016/s0002-9343(03)00117-7. No abstract available.

    PMID: 12727590BACKGROUND

  • Wallace JE, Lemaire JB, Ghali WA. Physician wellness: a missing quality indicator. Lancet. 2009 Nov 14;374(9702):1714-21. doi: 10.1016/S0140-6736(09)61424-0.

    PMID: 19914516BACKGROUND

  • O'Connor PG, Spickard A Jr. Physician impairment by substance abuse. Med Clin North Am. 1997 Jul;81(4):1037-52. doi: 10.1016/s0025-7125(05)70562-9.

    PMID: 9222267BACKGROUND

  • Spickard A Jr, Gabbe SG, Christensen JF. Mid-career burnout in generalist and specialist physicians. JAMA. 2002 Sep 25;288(12):1447-50. doi: 10.1001/jama.288.12.1447. No abstract available.

    PMID: 12243624BACKGROUND

  • Thomas NK. Resident burnout. JAMA. 2004 Dec 15;292(23):2880-9. doi: 10.1001/jama.292.23.2880.

    PMID: 15598920BACKGROUND

  • Crane M. Why burned-out doctors get sued more often. Med Econ. 1998 May 26;75(10):210-2, 215-8. No abstract available.

    PMID: 10179678BACKGROUND

  • Haas JS, Cook EF, Puopolo AL, Burstin HR, Cleary PD, Brennan TA. Is the professional satisfaction of general internists associated with patient satisfaction? J Gen Intern Med. 2000 Feb;15(2):122-8. doi: 10.1046/j.1525-1497.2000.02219.x.

    PMID: 10672116BACKGROUND

  • Shanafelt TD, West C, Zhao X, Novotny P, Kolars J, Habermann T, Sloan J. Relationship between increased personal well-being and enhanced empathy among internal medicine residents. J Gen Intern Med. 2005 Jul;20(7):559-64. doi: 10.1111/j.1525-1497.2005.0108.x.

    PMID: 16050855BACKGROUND

  • Shanafelt TD, Hasan O, Dyrbye LN, Sinsky C, Satele D, Sloan J, West CP. Changes in Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working Population Between 2011 and 2014. Mayo Clin Proc. 2015 Dec;90(12):1600-13. doi: 10.1016/j.mayocp.2015.08.023.

    PMID: 26653297BACKGROUND

  • West CP, Dyrbye LN, Erwin PJ, Shanafelt TD. Interventions to prevent and reduce physician burnout: a systematic review and meta-analysis. Lancet. 2016 Nov 5;388(10057):2272-2281. doi: 10.1016/S0140-6736(16)31279-X. Epub 2016 Sep 28.

    PMID: 27692469BACKGROUND

  • Fujimori M, Oba A, Koike M, Okamura M, Akizuki N, Kamiya M, Akechi T, Sakano Y, Uchitomi Y. Communication skills training for Japanese oncologists on how to break bad news. J Cancer Educ. 2003 Winter;18(4):194-201. doi: 10.1207/s15430154jce1804_6.

    PMID: 14766329BACKGROUND

  • Fujimori M, Shirai Y, Asai M, Akizuki N, Katsumata N, Kubota K, Uchitomi Y. Development and preliminary evaluation of communication skills training program for oncologists based on patient preferences for communicating bad news. Palliat Support Care. 2014 Oct;12(5):379-86. doi: 10.1017/S147895151300031X. Epub 2013 Nov 4.

    PMID: 24182602BACKGROUND

  • Goodman MJ, Schorling JB. A mindfulness course decreases burnout and improves well-being among healthcare providers. Int J Psychiatry Med. 2012;43(2):119-28. doi: 10.2190/PM.43.2.b.

    PMID: 22849035BACKGROUND

  • Krasner MS, Epstein RM, Beckman H, Suchman AL, Chapman B, Mooney CJ, Quill TE. Association of an educational program in mindful communication with burnout, empathy, and attitudes among primary care physicians. JAMA. 2009 Sep 23;302(12):1284-93. doi: 10.1001/jama.2009.1384.

    PMID: 19773563BACKGROUND

  • Ospina-Kammerer V, Figley CR. An evaluation of the Respiratory One Method (ROM) in reducing emotional exhaustion among family physician residents. Int J Emerg Ment Health. 2003 Winter;5(1):29-32.

    PMID: 12722487BACKGROUND

  • Rosdahl JA, Kingsolver KO. Mindfulness training to increase resilience and decrease stress and burnout in ophthalmology residents: A pilot study. Invest Ophthalmol Vis Sci. 2014;55(13):5579.

    BACKGROUND

  • Winefield H, Farmer E, Denson L. Work stress management for women general practitioners: An evaluation. Psychol Health Med. 1998;3(2):163-170.

    BACKGROUND

  • Dunn PM, Arnetz BB, Christensen JF, Homer L. Meeting the imperative to improve physician well-being: assessment of an innovative program. J Gen Intern Med. 2007 Nov;22(11):1544-52. doi: 10.1007/s11606-007-0363-5. Epub 2007 Sep 22.

    PMID: 17891503BACKGROUND

  • International Wellbeing Group. Personal Wellbeing Index: 5th edition. Melbourne: Australian Centre on Quality of Life, Deakin University; 2013.

    BACKGROUND

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND

  • Cohen S, Williamson G. Psychological stress in a probability sample of the United States. In: Spacapan S, Oskamp S, eds. The social psychology of health. Newbury Park, CA: Sage; 1988:31-67.

    BACKGROUND

  • Hojat M, Mangione S, Nasca T, et al. The Jefferson Scale of Physician Empathy: Development and Preliminary Psychometric Data. Educ Psychol Meas. 2001; 61(2):349-365.

    BACKGROUND

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Facility Design and Construction

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ArchitectureTechnology, Industry, and AgricultureHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Amanda Terry

    Center for CREATION Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2018

First Posted

January 29, 2018

Study Start

March 20, 2018

Primary Completion

March 28, 2019

Study Completion

March 28, 2019

Last Updated

April 1, 2019

Record last verified: 2019-03

Locations

US(1)