NCT04384861

Improving Physician Empathy, Compassionate Care and Wellness

Completed NA Last updated 9 May 2023

What this trial tests

NA trial testing Mayo Clinic SMART program (Stress Management and Resilience Training) in Burnout, Professional in 40 participants. Completed in 13 December 2019.

Timeline

31 July 2018

Primary endpoint
16 September 2019

13 December 2019

Quick facts

Lead sponsor	University of Ottawa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	31 July 2018
Primary completion	16 September 2019
Estimated completion	13 December 2019
Sites	1 location across Canada

Drugs / interventions tested

• Mayo Clinic SMART program (Stress Management and Resilience Training)

Conditions studied

• Burnout, Professional — all drugs for Burnout, Professional →
• Resilience — all drugs for Resilience →
• Stress, Emotional — all drugs for Stress, Emotional →

Sponsor

University of Ottawa

Who can join

18 and older, any sex, with Burnout, Professional or Resilience. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychological interventions to foster resilience in healthcare professionals.
   Kunzler AM, Helmreich I, Chmitorz A, König J, et al · · 2020 · cited 221× · PMID 32627860 · DOI 10.1002/14651858.cd012527.pub2
2. The impact of Stress Management and Resilience Training (SMART) on academic physicians during the implementation of a new Health Information System: An exploratory randomized controlled trial.
   Spilg EG, Kuk H, Ananny L, McNeill K, et al · · 2022 · cited 14× · PMID 35452478 · DOI 10.1371/journal.pone.0267240