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BurnoutNCT03413969

Building Physician Resiliency Through CREATION Health: A Research Study

A study testing CREATION in people with Burnout and Stress, run by AdventHealth at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Burnout, Stress, Well-being
What is being tested?
CREATION
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
20 Mar 2018to 28 Mar 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Florida Hospital

    Orlando, Florida, 32804

Other trials in United States

About this study

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

Read the detailed 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.

Being tested
CREATION
Medical subject headings
Burnout, Psychological

What participants receive

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

  • CREATIONBehavioural

    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.

Study groups in NCT03413969
Study groupRoleWhat they receive
Behavioral InterventionExperimentalThe 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.
Receives: Behavioral: CREATION

What is being measured

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

  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.

    Measured: 12 Months

Secondary outcomes (1)

  1. 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.

    Measured: 12 Months

Timeline

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

  1. First posted29 Jan 2018
  2. Study start20 Mar 2018
  3. Primary completion28 Mar 2019
  4. Study completion28 Mar 2019

Why it stopped: Study has been terminated due to recruitment challenges in targeted area.

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03413969
Sponsor's protocol ID
1090321
Status last verified
Mar 2019
First submitted
23 Jan 2018
Last updated
1 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22911330

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

  • 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

  • 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.

    PubMed 12727590

  • 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.

    PubMed 19914516

  • 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.

    PubMed 9222267

  • 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.

    PubMed 12243624

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

    PubMed 15598920

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

    PubMed 10179678

  • 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.

    PubMed 10672116

  • 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.

    PubMed 16050855

  • 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.

    PubMed 26653297

  • 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.

    PubMed 27692469

  • 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.

    PubMed 14766329

  • 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.

    PubMed 24182602

Questions about this trial

What is this clinical trial studying?

A study testing CREATION in people with Burnout and Stress, run by AdventHealth 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 6 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: stopped early, as of the sponsor's last update on 1 Apr 2019. 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 was stopped early (reason given: Study has been terminated due to recruitment challenges in targeted area.). Results are not available in the source record.

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?

Maslach Burnout Inventory - Human Services Survey (time frame: 12 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 NCT03413969, which also lists 25 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 1 Apr 2019.

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