Improving Physician Empathy, Compassionate Care and Wellness

May 8, 2023 updated by: Edward Spilg, University of Ottawa

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • University of Ottawa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACTIVE
The ACTIVE arm of the project received the Mayo Clinic SMART training (1 two-hour in-person workshop) and access to the Mayo Clinic's SMART eLearning Support study modules (4 x 45 minute modules in weeks 1-4; 20 x 10 minute modules weeks 5-24)
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.
Other Names:
  • Mayo Clinic SMART eLearning Support
No Intervention: CONTROL
The CONTROL did not receive any interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Administered prior to the intervention, and then at 12 and 24 weeks post-intervention
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
Administered prior to the intervention, and then at 12 and 24 weeks post-intervention
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
Administered prior to the intervention, and then at 12 and 24 weeks post-intervention
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
Administered prior to the intervention, and then at 12 and 24 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ottawa

Investigators

  • Principal Investigator: Edward Spilg, MD, University of Ottawa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2018

Primary Completion (Actual)

September 16, 2019

Study Completion (Actual)

December 13, 2019

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180536-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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