Improving Physician Empathy, Compassionate Care and Wellness

NCT04384861 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-05-09

No results posted yet for this study

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.

Conditions

  • Burnout, Professional
  • Resilience
  • Stress, Emotional

Interventions

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.

Sponsors & Collaborators

  • University of Ottawa

    lead OTHER

Principal Investigators

  • Edward Spilg, MD · University of Ottawa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2019-09-16
Completion
2019-12-13

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04384861 on ClinicalTrials.gov