Online MedEd Intern Bootcamp: Online Training for First Year Residents (OME-RCT)

May 14, 2025 updated by: Raji Ayinla, New York City Health and Hospitals Corporation

Effect of "Online MedEd" Intern Boot Camp Training on First Year Residents' Well-being: A Pilot Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Manhattan, New York, United States, 10037
        • Harlem Hospital Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

-incoming first year residents

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Enrolled into a 7 weeks online training program from May 13 2025 to June 30 2025
Behavioral: Online MedEd Intern Bootcamp
7 weeks, online training program
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Burnout at 3 months and 6 months.
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.
Baseline measurement, post-intervention measurements at 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants whose PHQ-9 total score is ≥ 10 at 3 months and 6 months
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.
Baseline measurement, post-intervention measurements at 3 months and 6 months
Change from baseline scores of the CBI-pb subscale at 3 months and 6 months.
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.
Baseline measurement, post-intervention measurements at 3 months and 6 months
Mean scores of the Mini ReZ subscales at 6 months
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).
6-month after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York City Health and Hospitals Corporation

Investigators

  • Principal Investigator: Raji Ayinla, M.D., CMD, FCCP, FACP, New York City Health and Hospitals Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 6, 2025

First Submitted That Met QC Criteria

May 14, 2025

First Posted (Actual)

May 18, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-08-130-273(HHC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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