- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03413969
Building Physician Resiliency Through CREATION Health: A Research Study
28 mars 2019 uppdaterad av: AdventHealth
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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
2
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Florida
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Orlando, Florida, Förenta staterna, 32804
- Florida Hospital
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Behavioral Intervention
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maslach Burnout Inventory - Human Services Survey
Tidsram: 12 Months
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Well-Being Item
Tidsram: 12 Months
|
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.
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12 Months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Perceived Stress Scale
Tidsram: 12 Months
|
The Perceived Stress Scale will be used to measure perceived stress.
The scores range from 0 to 40.
Higher scores indicate worse outcomes.
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12 Months
|
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Jefferson Scale of Empathy
Tidsram: 12 Months
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Amanda Terry, Center for CREATION Health Research
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- Thomas NK. Resident burnout. JAMA. 2004 Dec 15;292(23):2880-9. doi: 10.1001/jama.292.23.2880.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1016/s0025-7125(05)70562-9.
- 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.
- Crane M. Why burned-out doctors get sued more often. Med Econ. 1998 May 26;75(10):210-2, 215-8. No abstract available.
- 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.
- 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.
- 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.
- 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.
- Winefield H, Farmer E, Denson L. Work stress management for women general practitioners: An evaluation. Psychol Health Med. 1998;3(2):163-170.
- 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.
- International Wellbeing Group. Personal Wellbeing Index: 5th edition. Melbourne: Australian Centre on Quality of Life, Deakin University; 2013.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 mars 2018
Primärt slutförande (Faktisk)
28 mars 2019
Avslutad studie (Faktisk)
28 mars 2019
Studieregistreringsdatum
Först inskickad
23 januari 2018
Först inskickad som uppfyllde QC-kriterierna
26 januari 2018
Första postat (Faktisk)
29 januari 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 april 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 mars 2019
Senast verifierad
1 mars 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1090321
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