跳至主要内容
临床试验/NCT07707453
NCT07707453招募中不适用

The COMET Study: a Prospective COhort of MEdical residenTs to Assess Professional, Personal and Psychological Trajectories of Residents in General Internal Medicine

University of Fribourg3 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
3
主要终点
Change from baseline in psychological distress measured by the Physician Well-Being Index (PWBI)

研究概览

简要总结

Introduction.

Switzerland, like most Western countries, faces a paradox: an ageing, multimorbid population needs general internal medicine (GIM) physicians more than ever, yet fewer young doctors choose - and stay in - the specialty. Career decisions during residency are intertwined with well-being, mental and physical health, and work-life balance, and distress in training has been associated with depression, burnout, attrition and poorer patient care. Longitudinal data following GIM residents across these domains, and linking them to actual career trajectories, are lacking. The COMET study establishes a multicentre prospective cohort of GIM residents to fill this gap.

Methods and analysis.

COMET is a prospective, open, multicentre cohort conducted in the departments of (general) internal medicine of Fribourg Hospital (HFR, four sites), Bern University Hospital (Inselspital) and Lausanne University Hospital (CHUV). All GIM residents providing direct patient care are eligible (≈334 residents; expected enrolment ≥267, assuming 80% participation). Participants complete an annual online survey (REDCap; French or German) at baseline and for at least four years, covering sociodemographics; job characteristics; career intentions and 24 factors for or against a GIM career; well-being (Physician Well-Being Index, Professional Fulfillment Index, quality of life, work-life balance); mental health (CES-D, Perceived Stress Scale, Maslach Burnout Inventory, Questionnaire of Cognitive and Affective Empathy); and physical health (step counts, physical activity, fatigue, sleep, healthcare utilisation). Primary endpoints are the longitudinal course of well-being and distress (PWBI, PFI, CES-D) and residents' career trajectory. Analyses combine descriptive statistics, mixed-effects and regression models, and comparisons with the population-based CoLaus|PsyCoLaus cohort.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Resident physician in general internal medicine employed at a participating study site or annex centre during the recruitment period Written informed consent

排除标准

  • Not providing direct patient care Severe mental or physical condition precluding informed consent or compliance with the protocol

结局指标

主要结局

Change from baseline in psychological distress measured by the Physician Well-Being Index (PWBI)

时间窗: Baseline and annually at years 1, 2, 3, 4 and 5

The Physician Well-Being Index (resident version) comprises 7 yes/no items referring to the past month. Total score ranges from 0 to 7; higher scores indicate greater distress (worse outcome). A score of 3 or higher identifies residents at risk of distress

Change from baseline in professional fulfilment measured by the Professional Fulfillment Index (PFI) - professional fulfilment subscale

时间窗: Baseline and annually at years 1, 2, 3, 4 and 5

The professional fulfilment subscale of the Professional Fulfillment Index comprises 6 items scored 0-4 on 5-point scales (past two weeks); the subscale score is the item mean, ranging from 0 to 4. Higher scores indicate greater professional fulfilment (better outcome); scores of 3.0 or higher indicate professional fulfilment

Change from baseline in burnout measured by the Professional Fulfillment Index (PFI) - burnout composite

时间窗: Baseline and annually at years 1, 2, 3, 4 and 5

The burnout composite of the Professional Fulfillment Index comprises 10 items (4 work-exhaustion and 6 interpersonal-disengagement items) scored 0-4 on 5-point scales (past two weeks); the composite score is the item mean, ranging from 0 to 4. Higher scores indicate more severe burnout (worse outcome); scores of 1.33 or higher indicate burnout

Change from baseline in depressive symptoms measured by the Center for Epidemiologic Studies-Depression scale (CES-D)

时间窗: Baseline and annually at years 1, 2, 3, 4 and 5

The Center for Epidemiologic Studies-Depression scale comprises 20 items scored 0-3 by symptom frequency over the past week. Total score ranges from 0 to 60; higher scores indicate more depressive symptoms (worse outcome). A score of 16 or higher indicates clinically relevant depressive symptoms.

Percentage of participants remaining in general internal medicine training or practice

时间窗: Annually at years 1, 2, 3, 4 and 5

Proportion (%) of participants who, at each annual follow-up survey, report continuing postgraduate training or clinical activity in general internal medicine, versus having switched to another specialty or having left clinical medicine, assessed by structured self-report items (current work position and current specialty goal) of the annual COMET online survey

Intention to leave direct patient care, measured on a single-item 5-point scale

时间窗: Baseline and annually at years 1, 2, 3, 4 and 5

Single self-report item of the annual COMET survey rating the likelihood of leaving direct patient care within five years, from 1 (none) to 5 (high). Higher scores indicate a stronger intention to quit (worse outcome)

次要结局

  • Change from baseline in self-rated work-life balance (single-item 5-point scale)(Baseline and annually at years 1, 2, 3, 4 and 5)
  • Change from baseline in perceived stress measured by the Perceived Stress Scale (PSS-10)(Baseline and annually at years 1, 2, 3, 4 and 5)
  • Change from baseline in work exhaustion measured by the Professional Fulfillment Index (PFI) - work-exhaustion subscale(Baseline and annually at years 1, 2, 3, 4 and 5)
  • Change from baseline in interpersonal disengagement measured by the Professional Fulfillment Index (PFI) - interpersonal-disengagement subscale(Baseline and annually at years 1, 2, 3, 4 and 5)
  • Change from baseline in cognitive empathy measured by the Questionnaire of Cognitive and Affective Empathy (QCAE) - cognitive empathy subscale(Baseline and annually at years 1, 2, 3, 4 and 5)
  • Change from baseline in affective empathy measured by the Questionnaire of Cognitive and Affective Empathy (QCAE) - affective empathy subscale(Baseline and annually at years 1, 2, 3, 4 and 5)
  • Change from baseline in daily step count (smartphone-derived)(Baseline and annually at years 1, 2, 3, 4 and 5)
  • Change from baseline in self-reported physical activity measured by the International Physical Activity Questionnaire - short form (IPAQ-SF)(Baseline and annually at years 1, 2, 3, 4 and 5)
  • Change from baseline in fatigue measured by the Chalder Fatigue Scale(Baseline and annually at years 1, 2, 3, 4 and 5)
  • Change from baseline in insomnia severity measured by the Insomnia Severity Index (ISI)(Baseline and annually at years 1, 2, 3, 4 and 5)
  • Mean rating of each of 31 career pull and push factors (adapted Hauer questionnaire)(Baseline and annually at years 1, 2, 3, 4 and 5)
  • Difference in CES-D depressive-symptom score between residents and age-matched general-population participants (CoLaus|PsyCoLaus)(Baseline)
  • Difference in QCAE empathy scores between residents and Swiss medical students(Baseline and year 5)

研究者

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

Marco Mancinetti

Clinical Professor, Department of General Internal Medicine

University of Fribourg

研究点 (3)

Loading locations...

相似试验