NCT Number: NCT06977243
This single-center, parallel-group randomized controlled trial will evaluate whether a seven-week, web-based "Online MedEd Intern Boot Camp" (OME-IB) program reduces burnout in incoming first-year residents at NYC Health + Hospitals/Harlem. Eligible participants are PGY-1 physicians starting in July 2025 in Internal Medicine, Pediatrics, Emergency Medicine, Surgery, Psychiatry, Infectious Disease, or Nephrology who have not previously completed U.S. postgraduate training. After consent and baseline surveys, approximately 26 interns will be randomized 1:1 (stratified by sex and specialty) to either (1) immediate access to the OME-IB platform plus 14 peer-facilitated, one-hour Zoom sessions on mental health, time management, documentation, and oral presentation over May-June 2025, or (2) usual residency orientation without Boot Camp access until study completion.
The primary outcome is mean Maslach Burnout Inventory-Emotional Exhaustion (MBI-EE) score six months into residency. Secondary outcomes at six months include mean Copenhagen Burnout Inventory personal-burnout subscale, Mini ReZ supportive-work-environment/work-pace/resident-experience subscales, and Patient Health Questionnaire-9 (PHQ-9) depression score. Surveys are administered via REDCap at baseline (pre-intervention), three months, and six months; analyses follow an intention-to-treat approach with linear mixed models. Qualitative interviews will explore participants' experiences four months into residency. Findings will inform refinement of the OME-IB curriculum and future multi-site trials aimed at improving resident well-being.
Trial opening soon.
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Interventional
Not applicable
Manhattan, New York, 10037, United States
Bettina T Escolano, MD, MBA
SUB_INVESTIGATOR
Beverly Frederick
CONTACT
Denu Mawulorm, MD, MPH
SUB_INVESTIGATOR
Jay D Kahlenbeck, M.S
SUB_INVESTIGATOR
Jerel Phillips, MD
SUB_INVESTIGATOR
Marie Thearle, MD
SUB_INVESTIGATOR
Moustafa Ismail, MD
SUB_INVESTIGATOR
Rogelio R Guaita Soto, MD
SUB_INVESTIGATOR
Ronda Trousdale, MD
SUB_INVESTIGATOR
Shanna Wolfe
CONTACT
Scientific Rationale: Burnout in early postgraduate physicians has been linked to elevated emotional-exhaustion scores, major medical errors, and a 370 % rise in suicidal ideation during the first three months of training. Guided by the Job-Demands/Resources framework, OME-IB is designed to enhance job control (time-management, documentation efficiency) and personal resources (peer support, resilience skills) to offset the high demands of residency. Prior pilot work with web-based cognitive-behavioral programs in interns has shown clinically meaningful reductions in depressive symptoms, but no randomized evidence exists for a comprehensive boot-camp format that couples asynchronous video content with live, peer-led skills practice.
Intervention Engineering and Fidelity
The OME-IB curriculum will aim to empower residents in four competency streams-mental-health maintenance, time management, concise documentation, and effective oral presentation-anchor 14 one-hour Zoom workshops delivered twice weekly over seven weeks (May-June 2025). Each session follows the sequence:
Watch: Pre-assigned 10-minute OME video segment.
Practice: Live case or chart-note exercise in breakout dyads.
Reflect: Group debrief tied to OME-IB strategies
All Zoom calls are recorded; engagement metrics (minutes viewed, etc) are exported via the platform's API for dose-response analyses. Control-arm trainees will receive platform credentials only after the last six-month survey, ensuring contamination is minimized.
Data Acquisition and Quality Control: Surveys are deployed through a HIPAA-compliant REDCap instance with automated email nudges at 48 h and 96 h. De-identified datasets are stored on an encrypted institutional server; access is role-restricted and logged.
Embedded Qualitative Arm At four months into residency, a purposive subsample of intervention participants will undergo 30-45 min semi-structured interviews via Zoom. Using a pragmatic phenomenological lens, will use a mixed inductive/deductive scheme; tri-coder consensus, investigator triangulation, and member-checking will bolster trustworthiness.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-incoming first year residents
Exclusion criteria
7 weeks, online training program
Time frame: Baseline measurement, post-intervention measurements at 3 months and 6 months
The Maslach's burnout inventory is a 22-item measurement of worker burnout which assesses emotional exhaustion (EE), depersonalization (DP), and personal fulfillment (PF) domains. Possible scores range from 0-6 on a Likert scale for each item. Scores oof EE ≥ 27 points, DP ≥ 10, and PF <33 would indicate a high degree of burnout. Scores of EE≤18 points, DP≤5 points, and PF≥40 points would indicate a low degree of burnout.
Time frame: Baseline measurement, post-intervention measurements at 3 months and 6 months
Copenhagen Burnout Inventory personal burnout subscale (CBI-pb) is a tool used to assess personal burnout regardless of the work status.
Time frame: 6-month after the intervention
The Mini ReZ was adapted from the Mini Z for use in residents, using the Mini Z core 10 questions and 5 additional questions reflecting domains identified by Trockel. The interpretation is based on three subscales: Sub-scale 1 - Supportive Work Environment: add the numbered responses to questions 1-5. Range 5-25 (>=20 is a highly supportive work environment); Sub-scale 2 - Work pace and EHR Stress: add the numbered responses to questions 6-10. Range 5-25 (>=20 is an environment with good pace and manageable EHR stress); Subscale 3 - Resident Experience: add the numbered responses to questions 11-15. Range 5-25 (>=20 is a positive and healthy resident experience).
Time frame: Baseline measurement, post-intervention measurements at 3 months and 6 months
The Patient Health Questionnaire 9-item version (PHQ-9) to assess depressive symptoms. On PHQ-9, depression is categorized as minimal by a score of 0 to 4, mild by a score of 5 to 9, moderate by a score of 10 to 14, moderately severe by a score of 15 to 19, and severe by a score of 20 to 27. A total score ≥ 10 indicates clinically significant depressive symptoms. The outcome is the proportion of participants with a score ≥ 10 at 6 months. Lower proportions reflect better mental-health status.
Contact information is provided by the study sponsor or research team.
Jay D Kahlenbeck, M.A. (Clinical Psychology)
CONTACT
Rogelio R Guaita Soto, MD
CONTACT
New York City Health and Hospitals Corporation
Other
Effect of "Online MedEd" Intern Boot Camp Training on First Year Residents' Well-being: A Pilot Randomized Controlled Trial
Acronym: OME-RCT
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