跳至主要内容
临床试验/NCT04384861
NCT04384861已完成不适用

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

University of Ottawa2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change in Connor-Davidson Resilience Scale (CD-RISC) scores

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a full-time physician within the Department of Medicine at the Ottawa Hospital

排除标准

  • part-time physicians; those external to the department

结局指标

主要结局

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

时间窗: 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.

Change in Perceived Stress Scale (PSS) scores

时间窗: 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

Change in Generalized Anxiety Disorder-7 (GAD-7) scale scores

时间窗: 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

Change in Subjective Happiness Scale (SHS) scores

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edward Spilg

Assistant Professor and Research Chair in Physician Wellness

University of Ottawa

研究点 (2)

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