Online MedEd Intern Bootcamp: Online Training for First Year Residents
OME-RCT
Effect of "Online MedEd" Intern Boot Camp Training on First Year Residents' Well-being: A Pilot Randomized Controlled Trial
1 other identifier
interventional
59
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2025
CompletedFirst Submitted
Initial submission to the registry
May 6, 2025
CompletedFirst Posted
Study publicly available on registry
May 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMay 18, 2025
May 1, 2025
7 months
May 6, 2025
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline Burnout 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.
Baseline measurement, post-intervention measurements at 3 months and 6 months
Secondary Outcomes (3)
Change from baseline scores of the CBI-pb subscale at 3 months and 6 months.
Baseline measurement, post-intervention measurements at 3 months and 6 months
Mean scores of the Mini ReZ subscales at 6 months
6-month after the intervention
Proportion of participants whose PHQ-9 total score is ≥ 10 at 3 months and 6 months
Baseline measurement, post-intervention measurements at 3 months and 6 months
Study Arms (2)
Intervention
EXPERIMENTALEnrolled into a 7 weeks online training program from May 13 2025 to June 30 2025
Control
NO INTERVENTIONThe control group participants will receive residency orientation as per standard practice during June 2025, with no training sessions prior to starting the orientation to residency. The control group will be offered access to the online platform after completion of this study
Interventions
Eligibility Criteria
You may qualify if:
- incoming first year residents
You may not qualify if:
- Previous United States accredited postgraduate training
- House Officers
- Physician Assistant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Harlem Hospital Center
Manhattan, New York, 10037, United States
Related Publications (2)
Guille C, Zhao Z, Krystal J, Nichols B, Brady K, Sen S. Web-Based Cognitive Behavioral Therapy Intervention for the Prevention of Suicidal Ideation in Medical Interns: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Dec;72(12):1192-8. doi: 10.1001/jamapsychiatry.2015.1880.
PMID: 26535958BACKGROUNDRotenstein LS, Torre M, Ramos MA, Rosales RC, Guille C, Sen S, Mata DA. Prevalence of Burnout Among Physicians: A Systematic Review. JAMA. 2018 Sep 18;320(11):1131-1150. doi: 10.1001/jama.2018.12777.
PMID: 30326495BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raji Ayinla, M.D., CMD, FCCP, FACP
New York City Health and Hospitals Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Medicine
Study Record Dates
First Submitted
May 6, 2025
First Posted
May 18, 2025
Study Start
May 1, 2025
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
May 18, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available beginning 12 months after publication of the main results and for 5 years via the controlled-access repository Vivli
- Access Criteria
- Researchers with a methodologically sound proposal, IRB/ethics approval, and a signed data-use agreement may request access through the Vivli platform's review committee.
De-identified individual participant data (IPD) that underlie the primary and secondary outcome results (baseline demographic variables, intervention allocation, PHQ-9, CBI-PB, EE, Mini-ReZ scores at baseline, 3 months and 6 months, adverse-event indicators) plus the data dictionary and statistical analysis code will be shared. Direct identifiers (name, email, MRN, full dates of birth) and high-risk elements (audio/video files, free-text survey comments) will not be shared to protect confidentiality in this small cohort.