ClinicalTrials.gg
Not yet recruitingNCT06977243OME-RCTUpdated May 18, 2025

Online MedEd Intern Bootcamp: Online Training for First Year Residents

An interventional study of Online MedEd Intern Bootcamp in Burnout Among First Year Residents, sponsored by New York City Health and Hospitals Corporation. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-05-18.

Sponsored by New York City Health and Hospitals Corporation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Burnout Among First Year Residents

Keywords

  • Burnout
  • Wellness
  • Residents
  • Bootcamp
03

In context

Burnout, Psychological

467 studies on the registry are indexed under Burnout, Psychological; 121 are open to participants now.

This study's planned enrollment of 59 is below the median of 80 across 343 interventional studies indexed under Burnout, Psychological.

Browse Burnout, Psychological studies →

Lead sponsor

New York City Health and Hospitals Corporation is the lead sponsor of 28 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-incoming first year residents

Exclusion criteria

Exclusion Criteria:

  • Previous United States accredited postgraduate training
  • House Officers
  • Physician Assistant
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
59 participants (estimated)

Study arms

  • Experimental
    Intervention

    Enrolled into a 7 weeks online training program from May 13 2025 to June 30 2025

    Behavioral: Online MedEd Intern Bootcamp

  • No intervention
    Control

    The 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

  • BehavioralOnline MedEd Intern Bootcamp

    7 weeks, online training program

06

What researchers measure

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.

    Time frame: Baseline measurement, post-intervention measurements at 3 months and 6 months

Secondary outcomes

  1. Change from baseline scores of the CBI-pb subscale 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: Baseline measurement, post-intervention measurements at 3 months and 6 months

  2. Mean scores of the Mini ReZ subscales at 6 months

    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: 6-month after the intervention

  3. Proportion of participants whose PHQ-9 total score is ≥ 10 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.

    Time frame: Baseline measurement, post-intervention measurements at 3 months and 6 months

07

Study locations

1 site
  • Harlem Hospital Center
    Manhattan, New York 10037, United States
    • Beverly Frederick · ContactBeverly.Frederick@nychhc.org · 2129391406
    • Shanna Wolfe · ContactSHAWNA.WOLFE@nychhc.org · 2129391406
    • Rogelio R Guaita Soto, MD · Sub investigator
    • Jay D Kahlenbeck, M.S · Sub investigator
    • Bettina T Escolano, MD, MBA · Sub investigator
    • Denu Mawulorm, MD, MPH · Sub investigator
    • Moustafa Ismail, MD · Sub investigator
    • Jerel Phillips, MD · Sub investigator
    • Ronda Trousdale, MD · Sub investigator
    • Marie Thearle, MD · Sub investigator
08

References and documents

Publications

  • 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. PubMed 26535958 ↗
  • Rotenstein 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. PubMed 30326495 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2025; primary completion for Dec 2025, 7 months later.

Of 253 non-industry interventional studies with no phase under Burnout, Psychological, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 7 months is below that.

Counting every sponsor, half of 260 studies reached it within 12 months; a quarter within 5 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2025
First posted
May 18, 2025
StartEst.
May 2025
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
May 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06977243
Lead sponsor
New York City Health and Hospitals Corporation
Responsible party
Raji Ayinla (Director of Medicine, New York City Health and Hospitals Corporation) — Principal investigator
First posted
May 18, 2025
Start date
May 2025 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
May 18, 2025

Study contacts

Rogelio R Guaita Soto, MD
Contact
rogelior.guaitas@gmail.com
720-278-8589
Jay D Kahlenbeck, M.A. (Clinical Psychology)
Contact
jdk2181@tc.columbia.edu
317-752-5512
Raji Ayinla, M.D., CMD, FCCP, FACP
principal investigator · New York City Health and Hospitals Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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