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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03413969
Other study ID # 1090321
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 20, 2018
Est. completion date March 28, 2019

Study information

Verified date March 2019
Source Florida Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

This is a prospective, non-randomized study of a convenience sample of Centura Health physicians.This study will not include any drugs or devices. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date March 28, 2019
Est. primary completion date March 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CREATION
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.

Locations

Country Name City State
United States Florida Hospital Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Florida Hospital

Country where clinical trial is conducted

United States, 

References & Publications (25)

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

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.

Crane M. Why burned-out doctors get sued more often. Med Econ. 1998 May 26;75(10):210-2, 215-8. — View Citation

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. Epub 2007 Sep 22. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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

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. — View Citation

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

O'Connor PG, Spickard A Jr. Physician impairment by substance abuse. Med Clin North Am. 1997 Jul;81(4):1037-52. Review. — View Citation

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. — View Citation

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.

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. — View Citation

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. Erratum in: Mayo Clin Proc. 2016 Feb;91(2):276. — 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

Shanafelt TD, Sloan JA, Habermann TM. The well-being of physicians. Am J Med. 2003 Apr 15;114(6):513-9. — View Citation

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. — View Citation

Spickard A Jr, Gabbe SG, Christensen JF. Mid-career burnout in generalist and specialist physicians. JAMA. 2002 Sep 25;288(12):1447-50. — View Citation

Thomas NK. Resident burnout. JAMA. 2004 Dec 15;292(23):2880-9. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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

* Note: There are 25 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Perceived Stress Scale The Perceived Stress Scale will be used to measure perceived stress. The scores range from 0 to 40. Higher scores indicate worse outcomes. 12 Months
Other Jefferson Scale of Empathy The Jefferson Scale of Empathy will be used to assess empathy. The scores range from 0 to 140. Higher scores indicate better outcomes. 12 Months
Primary 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 Well-Being Item The following question will be asked to assess well-being: "How satisfied are you with your life as a whole?" The scores range from 0 to 10. Higher scores indicate better outcomes. 12 Months
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