Surgical ResidencySECONDNCT03739723
The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data - "The SECOND Trial"
A study testing Resource allocation to improve surgical learning environments in people with Surgical Residency and Workplace Culture, run by Indiana University at 1 site in United States.
Trial summary
Due to a number of factors, residents are susceptible to mistreatment (i.e., discrimination, harassment, and abuse) and toxic outcomes (i.e., burnout, attrition, and suicidality). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Residency, Workplace Culture, Mistreatment
- What is being tested?
- Resource allocation to improve surgical learning environments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Surgery training programs in the United States
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Surgical Outcomes and Quality Improvement Center
Indianapolis, Indiana, 46202
About this study
Official title: The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data (SECOND) Trial
Due to a number of factors, residents are susceptible to mistreatment (i.e., discrimination, harassment, and abuse) and toxic outcomes (i.e., burnout, attrition, and suicidality). Our work following the FIRST Trial identified considerable variation in program-level rates of resident-reported burnout, gender discrimination, racial discrimination, sexual harassment, and verbal abuse. To investigate these issues, the SECOND Trial will include a national mixed-methods analysis of and a pragmatic cluster-randomized controlled trial to improve the resident learning environment and trainee wellness.
Read the detailed description
The prospective, pragmatic cluster-randomized controlled trial will include approximately 320 surgical training programs across the United States. Participating programs will be randomized to the intervention or control arm. The intervention arm (vs. control) will receive program-specific reports about their learning environment and residents' well-being, as well as access to a Wellness Toolkit of ready-to-implement interventions. We will provide implementation support help facilitate and support intervention uptake throughout the trial period.
To assess the individual efficacy of the reports in regards to decreasing rates of mistreatment and toxic outcomes, the reports will be given to programs approximately 2 months to 6 months prior to Toolkit dissemination. Prior to Toolkit dissemination, programs will have the opportunity to fully review the report, form internal teams to address the issues, and mobilize necessary resources in preparation for receiving the Toolkit. A comprehensive list of all activities performed after report dissemination will be kept at a program-level. Toolkit dissemination to intervention programs will occur within 6 months of report dissemination. Coaching webinars and in-person/virtual conferences will be held at a variety of time points during the trial. The control arm will continue to perform their normal educational (including potential wellness) activities.
The investigators will compare multiple outcomes between the two study arms using data collected from an annual resident survey.
Extension of this work is anticipated to surgical subspecialty training programs (e.g., vascular surgery, cardiothoracic surgery). Eligible subspecialty programs will be assigned as per the randomization scheme of corresponding general surgery programs at their institution. Similar protocols will be in place for surgical subspecialties, with modifications to investigate specialty-specific survey items and interventions.
- Conditions
- Surgical Residency, Workplace Culture, Mistreatment, Burnout
- Being tested
- Resource allocation to improve surgical learning environments
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resource allocation to improve surgical learning environmentsOther
If a hospital/program is assigned to the intervention arm, they will receive numerous resources including a program-specific learning environment and resident well-being report, a Wellness Toolkit, coaching webinars, and in-person/virtual conferences to help improve their surgery learning environment and residents' well-being.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Programs will continue to conduct normal educational activities. |
| Intervention Arm | Experimental | The intent of the intervention arm is to provide programs with data and resources to inform and improve surgical learning environments and resident wellness. Receives: Other: Resource allocation to improve surgical learning environments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout
The primary outcome for the trial is reported rates of general surgery resident burnout.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Jun 2019
- Primary completion1 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical ResidencyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Surgeons, American Board of Surgery, Accreditation Council for Graduate Medical Education
- Responsible party
- Principal investigator, Karl Bilimoria, MD, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739723
- Sponsor's protocol ID
- SECOND Trial
- Acronym
- SECOND
- Status last verified
- Sep 2026
- First submitted
- 9 Nov 2018
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Janczewski LM, Buchheit JT, Golisch KB, Amortegui D, Mackiewicz N, Eng JS, Turner PL, Johnson JK, Bilimoria KY, Hu YY. Contemporary Evaluation of Work-Life Integration and Well-Being in US Surgical Residents: A National Mixed-Methods Study. J Am Coll Surg. 2024 Dec 1;239(6):515-526. doi: 10.1097/XCS.0000000000001135. Epub 2024 Nov 15.
PubMed 38920301
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Surgical Education Culture Optimization Through Targeted Interventions Based on National Comparative Data (SECOND) Trial
- ClinicalTrials.gov ID
- NCT03739723
- Acronym / sponsor ID
- SECOND / SECOND Trial
- Conditions
- Surgical Residency, Workplace Culture, Mistreatment, Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- American College of Surgeons, American Board of Surgery, Accreditation Council for Graduate Medical Education
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Nov 2018 (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.
Due to a number of factors, residents are susceptible to mistreatment (i.e., discrimination, harassment, and abuse) and toxic outcomes (i.e., burnout, attrition, and suicidality). Our work following the FIRST Trial identified considerable variation in program-level rates of resident-reported burnout, gender discrimination, racial discrimination, sexual harassment, and verbal abuse. To investigate these issues, the SECOND Trial will include a national mixed-methods analysis of and a pragmatic cluster-randomized controlled trial to improve the resident learning environment and trainee wellness.
Detailed description
The prospective, pragmatic cluster-randomized controlled trial will include approximately 320 surgical training programs across the United States. Participating programs will be randomized to the intervention or control arm. The intervention arm (vs. control) will receive program-specific reports about their learning environment and residents' well-being, as well as access to a Wellness Toolkit of ready-to-implement interventions. We will provide implementation support help facilitate and support intervention uptake throughout the trial period.
To assess the individual efficacy of the reports in regards to decreasing rates of mistreatment and toxic outcomes, the reports will be given to programs approximately 2 months to 6 months prior to Toolkit dissemination. Prior to Toolkit dissemination, programs will have the opportunity to fully review the report, form internal teams to address the issues, and mobilize necessary resources in preparation for receiving the Toolkit. A comprehensive list of all activities performed after report dissemination will be kept at a program-level. Toolkit dissemination to intervention programs will occur within 6 months of report dissemination. Coaching webinars and in-person/virtual conferences will be held at a variety of time points during the trial. The control arm will continue to perform their normal educational (including potential wellness) activities.
The investigators will compare multiple outcomes between the two study arms using data collected from an annual resident survey.
Extension of this work is anticipated to surgical subspecialty training programs (e.g., vascular surgery, cardiothoracic surgery). Eligible subspecialty programs will be assigned as per the randomization scheme of corresponding general surgery programs at their institution. Similar protocols will be in place for surgical subspecialties, with modifications to investigate specialty-specific survey items and interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Programs will continue to conduct normal educational activities. |
| Intervention Arm | Experimental | Other: Resource allocation to improve surgical learning environmentsThe intent of the intervention arm is to provide programs with data and resources to inform and improve surgical learning environments and resident wellness. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Surgery training programs in the United States
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Resource allocation to improve surgical learning environmentsIf a hospital/program is assigned to the intervention arm, they will receive numerous resources including a program-specific learning environment and resident well-being report, a Wellness Toolkit, coaching webinars, and in-person/virtual conferences to help improve their surgery learning environment and residents' well-being. | Other | Intervention Arm |
Primary outcome
Burnout
Time frame: 1 Year
The primary outcome for the trial is reported rates of general surgery resident burnout.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Derived from this study: PubMed 38920301Janczewski LM, Buchheit JT, Golisch KB, Amortegui D, Mackiewicz N, Eng JS, Turner PL, Johnson JK, Bilimoria KY, Hu YY. Contemporary Evaluation of Work-Life Integration and Well-Being in US Surgical Residents: A National Mixed-Methods Study. J Am Coll Surg. 2024 Dec 1;239(6):515-526. doi: 10.1097/XCS.0000000000001135. Epub 2024 Nov 15.
- Flexibility In duty hour Requirements for Surgical Trainees Trial - "The FIRST Trial"Link provided by the sponsor.
- Surgical Education Culture Optimization through targeted interventions based on National comparative Data (SECOND) TrialLink provided by the sponsor.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resource allocation to improve surgical learning environments in people with Surgical Residency and Workplace Culture, run by Indiana University 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 1 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: finished, as of the sponsor's last update on 23 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burnout (time frame: 1 Year). 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 NCT03739723, which also lists 1 linked publication.
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 23 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.