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Improving Physician Empathy, Compassionate Care and Wellness

Primary Purpose

Burnout, Professional, Resilience, Stress, Emotional

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mayo Clinic SMART program (Stress Management and Resilience Training)
Sponsored by
University of Ottawa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burnout, Professional focused on measuring Professional Burnout, Wellness, Emotional Stress, Resilience

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Ottawa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ACTIVE

CONTROL

Arm Description

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)

The CONTROL did not receive any interventions.

Outcomes

Primary Outcome Measures

Change in Connor-Davidson Resilience Scale (CD-RISC) scores
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.
Change in Perceived Stress Scale (PSS) scores
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
Change in Generalized Anxiety Disorder-7 (GAD-7) scale scores
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
Change in Subjective Happiness Scale (SHS) scores
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

Secondary Outcome Measures

Full Information

First Posted
April 28, 2020
Last Updated
May 8, 2023
Sponsor
University of Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT04384861
Brief Title
Improving Physician Empathy, Compassionate Care and Wellness
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
September 16, 2019 (Actual)
Study Completion Date
December 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ottawa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional, Resilience, Stress, Emotional
Keywords
Professional Burnout, Wellness, Emotional Stress, Resilience

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACTIVE
Arm Type
Experimental
Arm Description
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)
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
The CONTROL did not receive any interventions.
Intervention Type
Behavioral
Intervention Name(s)
Mayo Clinic SMART program (Stress Management and Resilience Training)
Other Intervention Name(s)
Mayo Clinic SMART eLearning Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Connor-Davidson Resilience Scale (CD-RISC) scores
Description
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.
Time Frame
Administered prior to the intervention, and then at 12 and 24 weeks post-intervention
Title
Change in Perceived Stress Scale (PSS) scores
Description
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
Time Frame
Administered prior to the intervention, and then at 12 and 24 weeks post-intervention
Title
Change in Generalized Anxiety Disorder-7 (GAD-7) scale scores
Description
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
Time Frame
Administered prior to the intervention, and then at 12 and 24 weeks post-intervention
Title
Change in Subjective Happiness Scale (SHS) scores
Description
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
Time Frame
Administered prior to the intervention, and then at 12 and 24 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Spilg, MD
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12964174
Citation
Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
Results Reference
background
PubMed Identifier
21895357
Citation
Mak WW, Ng IS, Wong CC. Resilience: enhancing well-being through the positive cognitive triad. J Couns Psychol. 2011 Oct;58(4):610-7. doi: 10.1037/a0025195.
Results Reference
background
PubMed Identifier
21974793
Citation
Mealer M, Jones J, Newman J, McFann KK, Rothbaum B, Moss M. The presence of resilience is associated with a healthier psychological profile in intensive care unit (ICU) nurses: results of a national survey. Int J Nurs Stud. 2012 Mar;49(3):292-9. doi: 10.1016/j.ijnurstu.2011.09.015. Epub 2011 Oct 5.
Results Reference
background
PubMed Identifier
23808920
Citation
McGarry S, Girdler S, McDonald A, Valentine J, Lee SL, Blair E, Wood F, Elliott C. Paediatric health-care professionals: relationships between psychological distress, resilience and coping skills. J Paediatr Child Health. 2013 Sep;49(9):725-32. doi: 10.1111/jpc.12260. Epub 2013 Jul 1.
Results Reference
background
Citation
Lü W, Wang Z, Liu Y, Zhang H. Resilience as a mediator between extraversion, neuroticism and happiness, PA and NA. Personal Individ Differ. 2014;63:128-133
Results Reference
background
PubMed Identifier
29018095
Citation
Fox S, Lydon S, Byrne D, Madden C, Connolly F, O'Connor P. A systematic review of interventions to foster physician resilience. Postgrad Med J. 2018 Mar;94(1109):162-170. doi: 10.1136/postgradmedj-2017-135212. Epub 2017 Oct 10.
Results Reference
background
PubMed Identifier
25443423
Citation
Sood A, Sharma V, Schroeder DR, Gorman B. Stress Management and Resiliency Training (SMART) program among Department of Radiology faculty: a pilot randomized clinical trial. Explore (NY). 2014 Nov-Dec;10(6):358-63. doi: 10.1016/j.explore.2014.08.002. Epub 2014 Aug 21.
Results Reference
background
Citation
Charmaz K. Constructing Grounded Theory. Sage; 2014. https://us.sagepub.com/en-us/nam/constructing-grounded-theory/book235960. Accessed December 21, 2017
Results Reference
background
PubMed Identifier
35452478
Citation
Spilg EG, Kuk H, Ananny L, McNeill K, LeBlanc V, Bauer BA, Sood A, Wells PS. The impact of Stress Management and Resailience Training (SMART) on academic physicians during the implementation of a new Health Information System: An exploratory randomized controlled trial. PLoS One. 2022 Apr 22;17(4):e0267240. doi: 10.1371/journal.pone.0267240. eCollection 2022.
Results Reference
derived

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Improving Physician Empathy, Compassionate Care and Wellness

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