Improving Physician Empathy, Compassionate Care and Wellness

Burnout, Professional Clinical Trial

Official title:

Phase Three: Improving Physician Empathy, Compassionate Care and Wellness Through the Development of Resilience-building Communities of Practice and Creating a Culture of Empathy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04384861
• Other study ID #: 20180536-01H
• Status: Completed
• Phase: N/A
• Start date: July 31, 2018
• Est. completion date: December 13, 2019

Study information

• Verified date: May 2023
• Source: University of Ottawa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background

Definitions of resilience vary according to the context in which it is discussed. It is often considered from the perspective of the individual. Connor & Davidsondescribe it as "the personal qualities that enable an individual to thrive in the face of adversity". Various studies have now shown a link between individual resilience and various mental health outcomes such as burnout, secondary traumatic stress, depression, and anxiety. In a systematic review by Fox et al., 22 studies explicitly stated an aim of improving physician resilience. However, there was a lack of consensus concerning the conceptual understanding of resilience with low methodological rigour of the included studies.

Research Questions

1. What effect will an evidence-based resilience building intervention have on levels of resilience, stress and subjective happiness in Department of Medicine Faculty at the University of Ottawa?

2. How might implementation of an evidence-based resilience building intervention on Department of Medicine faculty, lead to the development of a community of practice for physician wellness in the Department of Medicine at The Ottawa Hospital/University of Ottawa?

Methods All academic physicians in the Department of Medicine, University of Ottawa were invited to participate. We recruited 40 participants in total, randomized to either the ACTIVE or CONTROL groups.

Workshop ACTIVE participants (Group A) attended a 2-hour Stress Management and Resiliency Training (SMART) program developed by the Mayo Clinic. CONTROL (Group B) participants did not attend this training.

Questionnaires Both Group A & B completed questionnaires on resilience, perceived stress, anxiety and happiness at 0 weeks (pre-training) and 12 and 24-weeks post training.

E-learning support Following completion of the 2-hour workshop, Group A participants were enrolled in an online e-learning support program on a website developed by the Mayo Clinic. The aim of this was to support and reinforce the messages and techniques delivered in the 2-hour workshop. Participants were invited to participate for either 12 or 24 weeks.

Focus groups Group A participants were invited to join a focus group 12 weeks after the workshop was run. These focus groups explored themes of resilience, stress, and burnout.

Analysis of Results Quantitative (Questionnaires): For each measurement scale, the change from baseline will be compared between groups (Active Arm and Control Arm) using the two-sample t-test. To supplement these analyses, the within-group change (baseline vs week 4/12/24) will be assessed for the Active Arm using the paired t-test. A sample size of 40 was selected for this study after weighing statistical considerations along with logistical and resource constraints. In general, for a continuous outcome variable, a sample size of 40 provides statistical power (two-tailed, alpha=0.05) of >85% to detect a difference of 1 standard deviation between groups.

Qualitative (Focus Groups): Constructivist grounded theory informed the iterative data collection and analysis process. Transcripts were analysed using a three-staged process of initial, focused, and theoretical coding. Themes will be identified using constant comparative analysis and grouped to look at the interrelationship of categories.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 13, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a full-time physician within the Department of Medicine at the Ottawa Hospital

Exclusion Criteria:

• part-time physicians; those external to the department

Related Conditions & MeSH terms

• Burnout, Professional
• Burnout, Psychological
• Resilience
• Stress, Emotional

Intervention

Behavioral:
• Mayo Clinic SMART program (Stress Management and Resilience Training)
The SMART program included a workshop and ongoing eLearning Support. The learning objectives of the workshop are: (1) learn the neuroscience and behavioural aspects of human experience, particularly with respect to stress, resiliency, performance and wellness and (2) learn practical approaches to enhance engagement and emotional intelligence and thereby decrease stress and anxiety, increase resilience, enhance performance, and improve relationships. The goal of the eLearning support is to support and reinforce the messages and techniques delivered in the 2-hour workshop.

Locations

Country	Name	City	State
Canada	University of Ottawa	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

References & Publications (8)

Charmaz K. Constructing Grounded Theory. Sage; 2014. https://us.sagepub.com/en-us/nam/constructing-grounded-theory/book235960. Accessed December 21, 2017

Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113. — View Citation

Fox S, Lydon S, Byrne D, Madden C, Connolly F, O'Connor P. A systematic review of interventions to foster physician resilience. Postgrad Med J. 2018 Mar;94(1109):162-170. doi: 10.1136/postgradmedj-2017-135212. Epub 2017 Oct 10. — View Citation

Lü W, Wang Z, Liu Y, Zhang H. Resilience as a mediator between extraversion, neuroticism and happiness, PA and NA. Personal Individ Differ. 2014;63:128-133

Mak WW, Ng IS, Wong CC. Resilience: enhancing well-being through the positive cognitive triad. J Couns Psychol. 2011 Oct;58(4):610-7. doi: 10.1037/a0025195. — View Citation

McGarry S, Girdler S, McDonald A, Valentine J, Lee SL, Blair E, Wood F, Elliott C. Paediatric health-care professionals: relationships between psychological distress, resilience and coping skills. J Paediatr Child Health. 2013 Sep;49(9):725-32. doi: 10.1111/jpc.12260. Epub 2013 Jul 1. — View Citation

Mealer M, Jones J, Newman J, McFann KK, Rothbaum B, Moss M. The presence of resilience is associated with a healthier psychological profile in intensive care unit (ICU) nurses: results of a national survey. Int J Nurs Stud. 2012 Mar;49(3):292-9. doi: 10.1016/j.ijnurstu.2011.09.015. Epub 2011 Oct 5. — View Citation

Sood A, Sharma V, Schroeder DR, Gorman B. Stress Management and Resiliency Training (SMART) program among Department of Radiology faculty: a pilot randomized clinical trial. Explore (NY). 2014 Nov-Dec;10(6):358-63. doi: 10.1016/j.explore.2014.08.002. Epub 2014 Aug 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Connor-Davidson Resilience Scale (CD-RISC) scores	utilized for the assessment of the self-reported measures of resilience and the ability to cope with adversity; 25 questions; responses from 0 to 4; minimum total score: 0; maximum total score 100; higher scores indicative of greater levels of resilience.	Administered prior to the intervention, and then at 12 and 24 weeks post-intervention
Primary	Change in Perceived Stress Scale (PSS) scores	utilized to assess participant's level of perceived stress; 10 questions; responses from 0 to 4; minimum total score: 0; maximum total score: 40; higher scores indicative of higher perceived chronic levels of stress	Administered prior to the intervention, and then at 12 and 24 weeks post-intervention
Primary	Change in Generalized Anxiety Disorder-7 (GAD-7) scale scores	utilized in the assessment of anxiety; 7 questions; responses from 0 to 3; minimum total score: 0; maximum total score 21; higher scores indicative of severe anxiety symptoms	Administered prior to the intervention, and then at 12 and 24 weeks post-intervention
Primary	Change in Subjective Happiness Scale (SHS) scores	utilized to assess participant's level of global subjective happiness; 4 questions; responses from 1 to 7; minimum total score: 4; maximum total score 28; higher scores indicative of higher levels of subjective happiness	Administered prior to the intervention, and then at 12 and 24 weeks post-intervention