- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06970340
- Original Trial
Online MedEd Intern Bootcamp: Hybrid (Online+Live) Training for First Year Residents (2024-OME-RCT)
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Manhattan, New York, United States, 10037
- Harlem Hospital Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Investigators
- Principal Investigator: Raji Ayinla, M.D., CMD, FCCP, FACP, New York City Health and Hospitals Corporation
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-08-221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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
-
New York City Health and Hospitals CorporationNot yet recruitingBurnout Among First Year ResidentsUnited States
-
Senem DumanCompletedFirst Year StudentsTurkey (Türkiye)
-
University of Paris 5 - Rene DescartesUnknownHealth Studies First-year Course SelectionFrance
-
University of MinnesotaNational Heart, Lung, and Blood Institute (NHLBI); University of Ghana; Syracuse... and other collaboratorsCompletedIncrease Repeat Blood Donation Attempts Among First-time DonorsUnited States
-
David Grant U.S. Air Force Medical CenterCompletedBurnout Among Family Medicine Resident PhysiciansUnited States
-
Memorial Healthcare SystemHarvard Medical School (HMS and HSDM); University of Miami; Vanderbilt University...CompletedBurnout, Professional | Well-Being, Psychological | Surgical ResidentsUnited States
-
Sohag UniversityNot yet recruitingElderly Cardiac Patients With Multimorbidity and Burnout Among Their Caregivers
-
Orange Park Medical CenterUnknownBurnout, Professional | Mental Health Disorder | Mental Health Wellness 1 | Resident Wellness | Medical Residents | Resident PhysicianUnited States
-
Saint-Louis Hospital, Paris, FranceCompletedPrevalence of Burn-out Among Intensive Care ProfessionalsBelgium
Clinical Trials on Online MedEd Intern Bootcamp
-
New York City Health and Hospitals CorporationNot yet recruitingBurnout Among First Year ResidentsUnited States