Improving Physician Empathy, Compassionate Care and Wellness

Sponsor
University of Ottawa (Other)
Overall Status
Completed
CT.gov ID
NCT04384861
Collaborator
(none)
40
1
2
16.4
2.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mayo Clinic SMART program (Stress Management and Resilience Training)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Physician volunteers were first divided by gender and then randomly assigned to either the CONTROL (no SMART Wellness training) or ACTIVE (received SMART Wellness training) arms of the study.Physician volunteers were first divided by gender and then randomly assigned to either the CONTROL (no SMART Wellness training) or ACTIVE (received SMART Wellness training) arms of the study.
Masking:
Single (Participant)
Masking Description:
Because the SMART training & Focus Groups were done in groups, ACTIVE participants were not masked from each other or the Investigators. Because the CONTROL participants did not attend any in-person meetings, they were masked from each other, the ACTIVE participants and the Investigator.
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jul 31, 2018
Actual Primary Completion Date :
Sep 16, 2019
Actual Study Completion Date :
Dec 13, 2019

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Ottawa Ottawa Ontario Canada K1H 8L1

    Sponsors and Collaborators

    • University of Ottawa

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Edward Spilg, Assistant Professor and Research Chair in Physician Wellness, University of Ottawa
    ClinicalTrials.gov Identifier:
    NCT04384861
    Other Study ID Numbers:
    • 20180536-01H
    First Posted:
    May 12, 2020
    Last Update Posted:
    May 12, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Edward Spilg, Assistant Professor and Research Chair in Physician Wellness, University of Ottawa
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 12, 2020