Online MedEd Intern Bootcamp: Hybrid (Online+Live) Training for First Year Residents (2024-OME-RCT)

May 13, 2025 updated by: Raji Ayinla, New York City Health and Hospitals Corporation

Pilot Program: Effect of "Online MedEd" Intern Bootcamp Training on First Year Residents' Well-being and Skills Confidence. A Randomized Controlled Trial

This study is testing a web-based "Intern Boot Camp" from Online MedEd to see if it can make the first year of residency less stressful for new internal-medicine doctors at Harlem Hospital. Right after orientation, residents are randomly placed into one of two groups:

Intervention group - gets six months of free access to the Bootcamp videos plus twice-a-week, one-hour review sessions led by senior residents the first 6 months of residency

Control group - gets the hospital's usual training and will receive the Bootcamp training starting at 6-month of residency.

The main thing the researchers want to know is: Does using the Boot Camp lower burnout-especially emotional exhaustion-compared with usual training? They will also look at the PHQ-9 depression survey and how confident residents feel about four everyday skills: mental health self-care, time management, oral presentation, and medical documentation. Surveys are completed at the start of residency and again six months later. Findings will show whether giving residents structured, on-demand preparation improves their well-being and confidence during the toughest part of their training.

Study Overview

Status

Active, not recruiting

Detailed Description

New interns often describe their first months of residency as a "trial by fire." Studies show that roughly one-third of U.S. residents develop significant depressive symptoms during training, and burnout-particularly feeling emotionally drained-has been linked to more medical errors and even suicidal thinking . OnlineMedEd's Intern Boot Camp (OME-IBC) is an on-demand video course endorsed by the American College of Physicians to help graduating medical students get ready for residency, yet no one has formally tested whether it actually improves interns' well-being in a busy urban hospital setting .

This single-center pilot study will recruit the entire 2024-2025 class of first-year residents at Harlem Hospital. After obtaining consent, participants complete a baseline survey and are then randomly assigned (1:1) to one of two groups, stratified by sex, specialty and Emotional Exhaustion score.

Intervention group - receives six months of free access to the password-protected OME-IBC website plus twice-weekly, one-hour review sessions led by senior residents. Each two- to three-week mini-unit focuses on one of four practical domains-mental-health self-care, time management, oral presentation, and documentation. Participants watch a short video together and discuss it. The full curriculum spans about 35 sessions and can also be viewed asynchronously.

Control group - follows the program's usual orientation and on-the-job teaching without Bootcamp access during the first six months. After the 6-month, they are offered the same OME-IBC access and review sessions.

Outcomes

Primary outcome: change in emotional-exhaustion scores on the Maslach Burnout Inventory (MBI). A ≥27 on the EE subscale indicates high burnout; every one-point rise has been tied to a 5-7 % jump in suicidal ideation or major errors.

Secondary outcomes:

Changes in overall burnout (other MBI subscales)

Depressive-symptom severity on the PHQ-9 (0-27 scale)

Self-rated confidence (1 = "minimally confident" to 5 = "very confident") in the four Bootcamp skill areas

Study Type

Interventional

Enrollment (Actual)

24

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 Locations

    • New York
      • Manhattan, New York, United States, 10037
        • Harlem Hospital Center

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 of residency

Exclusion Criteria:

  • Previous United States Accredited Postgraduate Training
  • PHQ-9 score above 20
  • PHQ-9 positive for suicidality (question 9)

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Enrolled into a 6-month online training program plus biweekly live discussion sessions from July 15 2024 to January 15 2025
6 months of online access plus biweekly live sessions
No Intervention: Control
Residency training as usual. No access to online training platform or live sessions.

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 of 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

Collaborators and Investigators

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

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.

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 (Actual)

July 2, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 6, 2025

First Submitted That Met QC Criteria

May 6, 2025

First Posted (Actual)

May 14, 2025

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 24-08-221

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, MBI, Mini-ReZ scores at baseline, 3 months and 6 months 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.

Clinical Trials on Burnout Among First Year Residents

Clinical Trials on Online MedEd Intern Bootcamp

Subscribe