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Completed

NCT Number: NCT04384861

Improving Physician Empathy, Compassionate Care and Wellness

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.

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Key information

Conditions

Burnout, Professional Behavior Behavioral Symptoms Burnout, Psychological Occupational Diseases Occupational Stress Resilience Stress, Emotional Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa

Ottawa, Ontario, K1H 8L1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mayo Clinic SMART program (Stress Management and Resilience Training)

Behavioral

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.

Other names: Mayo Clinic SMART eLearning Support

Primary outcomes

  1. Change in Connor-Davidson Resilience Scale (CD-RISC) scores

    Time frame: Administered prior to the intervention, and then at 12 and 24 weeks post-intervention

    • 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.

  2. Change in Perceived Stress Scale (PSS) scores

    Time frame: Administered prior to the intervention, and then at 12 and 24 weeks post-intervention

    • 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

  3. Change in Generalized Anxiety Disorder-7 (GAD-7) scale scores

    Time frame: Administered prior to the intervention, and then at 12 and 24 weeks post-intervention

    • 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

  4. Change in Subjective Happiness Scale (SHS) scores

    Time frame: Administered prior to the intervention, and then at 12 and 24 weeks post-intervention

    • 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

Sponsors and collaborators

Lead sponsor

University of Ottawa

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 12, 2020
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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