NCT06977243

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

May 6, 2025

Last Update Submit

May 14, 2025

Conditions

Keywords

BurnoutWellnessResidentsBootcamp

Outcome Measures

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.

    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.

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

  • Mean scores of the Mini ReZ subscales at 6 months

    6-month after the intervention

  • Proportion of participants whose PHQ-9 total score is ≥ 10 at 3 months and 6 months

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

Study Arms (2)

Intervention

EXPERIMENTAL

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

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

Interventions

7 weeks, online training program

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • incoming first year residents

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harlem Hospital Center

Manhattan, New York, 10037, United States

Location

Related Publications (2)

  • 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.

    PMID: 26535958BACKGROUND
  • 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.

    PMID: 30326495BACKGROUND

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Raji Ayinla, M.D., CMD, FCCP, FACP

    New York City Health and Hospitals Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rogelio R Guaita Soto, MD

CONTACT

Jay D Kahlenbeck, M.A. (Clinical Psychology)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Medicine

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 18, 2025

Study Start

May 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations