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

NCT07707453 | Recruiting

• 1 other identifier: CERV-VD Project-ID 2024-00444
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Burnout Syndrome; Depression Disorder; Insomnia; Perceived Stress; Fatigue Symptom; Empathy

Outcome Measures

Primary Outcomes (6)

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

  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

  Baseline and annually at years 1, 2, 3, 4 and 5

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

  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

  Baseline and annually at years 1, 2, 3, 4 and 5

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

  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

  Baseline and annually at years 1, 2, 3, 4 and 5

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

  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.

  Baseline and annually at years 1, 2, 3, 4 and 5

• Percentage of participants remaining in general internal medicine training or practice

  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

  Annually at years 1, 2, 3, 4 and 5

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

  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)

  Baseline and annually at years 1, 2, 3, 4 and 5

Secondary Outcomes (13)

• 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

Study Arms (1)

Residents in General Internal Medicine (GIM)

All residents in GIM in the participating centers in Switzerland

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

resident physicians in general internal medicine at approximately 22 Swiss hospital and ambulatory centres (\~1,300 eligible)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Fribourg: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• Hôpital Fribourgeois: collaborator
• University of Lausanne Hospitals: collaborator

Study Sites (3)

Inselspital - University Hospital

Bern, Switzerland

RECRUITING

HFR - Hôpital Cantonal

Fribourg, 1700, Switzerland

RECRUITING

CHUV - University Hospital

Lausanne, Switzerland

RECRUITING

MeSH Terms

Conditions

Burnout, Psychological; Sleep Initiation and Maintenance Disorders; Fatigue

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

marco mancinetti, MD

CONTACT

0041263062360; marco.mancinetti@unifr.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Department of General Internal Medicine

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 16, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

CH (3)