Burnout Among First Year ResidentsOME-RCTNCT06977243
Online MedEd Intern Bootcamp: Online Training for First Year Residents
A study testing Online MedEd Intern Bootcamp in people with Burnout Among First Year Residents, run by New York City Health and Hospitals Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout Among First Year Residents
- What is being tested?
- Online MedEd Intern Bootcamp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- May 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -incoming first year residents
Who cannot join
- Previous United States accredited postgraduate training
- House Officers
- Physician Assistant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Harlem Hospital Center
Manhattan, New York, 10037
Beverly Frederick, 2129391406, Beverly.Frederick@nychhc.org
Shanna Wolfe, 2129391406, SHAWNA.WOLFE@nychhc.org
About this study
Official title: 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.
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.
- Conditions
- Burnout Among First Year Residents
- Being tested
- Online MedEd Intern Bootcamp
- Keywords
- Burnout, Wellness, Residents, Bootcamp
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online MedEd Intern BootcampBehavioural
7 weeks, online training program
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Enrolled into a 7 weeks online training program from May 13 2025 to June 30 2025 Receives: Behavioral: Online MedEd Intern Bootcamp |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Copenhagen Burnout Inventory personal burnout subscale (CBI-pb) is a tool used to assess personal burnout regardless of the work status.
Measured: Baseline measurement, post-intervention measurements at 3 months and 6 months
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).
Measured: 6-month after the intervention
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.
Measured: Baseline measurement, post-intervention measurements at 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study startMay 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Burnout Among First Year ResidentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York City Health and Hospitals Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raji Ayinla, New York City Health and Hospitals Corporation
- Investigators
- Raji Ayinla, M.D., CMD, FCCP, FACP, Principal investigator, New York City Health and Hospitals Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977243
- Sponsor's protocol ID
- 25-08-130-273(HHC)
- Acronym
- OME-RCT
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 26535958Rotenstein 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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of "Online MedEd" Intern Boot Camp Training on First Year Residents' Well-being: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06977243
- Acronym / sponsor ID
- OME-RCT / 25-08-130-273(HHC)
- Conditions
- Burnout Among First Year Residents
- Keywords
- Burnout, Wellness, Residents, Bootcamp
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Online MedEd Intern BootcampEnrolled into a 7 weeks online training program from May 13 2025 to June 30 2025 |
| Control | No intervention | –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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -incoming first year residents
Key exclusion criteria (3 listed)
- Previous United States accredited postgraduate training
- House Officers
- Physician Assistant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online MedEd Intern Bootcamp7 weeks, online training program | Behavioural | Intervention |
Primary outcome
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.
3 secondary outcomes
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
Mean scores of the Mini ReZ subscales at 6 months
Time frame: 6-month after the intervention
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: PubMed 26535958Guille 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.
- Background: PubMed 30326495Rotenstein 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.
- Individual participant dataSharing planned: 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.
Related trials for Burnout Among First Year Residents
Active, not recruiting
Online MedEd Intern Bootcamp: Hybrid (Online+Live) Training for First Year Residents
Burnout Among First Year Residents
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raji Ayinla, M.D., CMD, FCCP, FACP principal investigator
New York City Health and Hospitals Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online MedEd Intern Bootcamp in people with Burnout Among First Year Residents, run by New York City Health and Hospitals Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rogelio R Guaita Soto, MD (720-278-8589, rogelior.guaitas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Burnout at 3 months and 6 months. (time frame: Baseline measurement, post-intervention measurements at 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06977243, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.