How will the SECOND Trial examine whether program-specific data and/or the Toolkit work?
At the conclusion of the trial, metrics of the learning environment and resident well-being (e.g., burnout) will be compared between the intervention and control groups to assess the intervention’s effectiveness. Both baseline and follow-up data will be obtained from the ABSITE survey, which is administered to all residents in ACGME-approved general surgery programs and typically has a >99% response rate.
Why randomize? Isn’t it unethical to withhold resources from the control group?
Both trial arms will have access to data about their residency (e.g., burnout), but only intervention arm programs will have access to the Learning Environment Report, Wellness Toolkit, and the implementation support. Because there is currently very little data about the effectiveness of any wellness interventions and many are expensive and/or time/effort-intensive, the Bioethics Panel that we convened has concluded that the SECOND Trial has equipoise.
Randomization also will allow us to address the secular trend of increasing emphasis on wellness, as programs who are independently embarking on wellness initiatives should be evenly divided between intervention and control arms. We will will also closely track the wellness changes implemented at all programs in both study arms annually.
After the conclusion of the trial, after the Wellness Toolkit has been refined, we will expand access to all enrolled programs.
Who is conducting the SECOND Trial?
Like the FIRST Trial, the SECOND Trial is a joint effort among the Accreditation Council for Graduate Medical Education, the American College of Surgeons, the Association of Program Directors in Surgery, and the American Board of Surgery. As in the FIRST Trial, the ACGME will not have access to the data; this is clearly stated in our contract with each program and with the ACGME. The Surgical Outcomes and Quality Improvement Center (SOQIC) at the Northwestern University Feinberg School of Medicine will serve as the data center for the trial.
How will the confidentiality of individual residents be protected?
We recognize that these are sensitive topics. All individual resident identifiers are removed from survey data prior to transfer to the data center; identification of individual residents is not possible. Program-Specific Reports will be provided as quartiles (i.e., for burnout, your program ranks in the first or best quartile of programs in the country). We will not provide programs with the responses of individual residents or even the proportion of their residents that reported any particular metric, thus precluding attempts to identify the residents who might have reported any particular issue. During program tours, all interviews and focus groups will be conducted confidentially.
How will the confidentiality of programs be protected?
ABSITE survey data are sent to the data center, and programs are immediately de-identified. It is maintained in de-identified form throughout all analyses. Program-Specific Reports will be generated using program-level linkages, which are securely maintained.
Much like other clinical quality improvement programs, we will mandate that programs cannot disseminate or publicize/advertise the data in their reports outside of their institutions. We encourage sharing within each institution (i.e., with residents and faculty), but this decision will be left to the discretion of each program director, chair, and DIO.
When will the SECOND Trial start and end?
Recruitment for the trial will occur in spring 2019, with randomization occurring in summer 2019. All programs will receive data in early fall 2019. Wellness Toolkit access will occur in fall 2019. Resident wellness surveys will be conducted in January 2019, 2020, 2021, and 2022. All programs will be given access to the Wellness Toolkit in 2022.