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 an 85-99% response rate.
Why randomize? Isn’t it unethical to withhold resources from the control group?
Both trial arms have access to data about their residents’ well-being (e.g., burnout) and interventions regarding suicide, but only intervention arm programs have access to the Learning Environment Report, Wellness Toolkit, and the implementation support. Because there is currently little data about the effectiveness of any wellness interventions and many are expensive and/or time/effort-intensive, our Bioethics Panel concluded that the SECOND Trial has equipoise.
Randomization allows 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 closely track the wellness interventions implemented at all programs in both study arms annually.
After the conclusion of the Trial, access to the Wellness Toolkit will be expanded 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, American College of Surgeons, Association of Program Directors in Surgery, the American Board of Surgery, the Association of American Medical Colleges, and the Society of Surgical Chairs. 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 serves 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 being transferred to SOQIC; identification of individual residents by the study team is not possible. Data metrics on our Program-Specific Reports are provided as quartiles (i.e., for burnout, your program ranks in the first (best) quartile of programs in the country). We do 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 are conducted confidentially.
How will the confidentiality of programs be protected?
ABSITE survey data are sent to SOQIC, 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?
Trial enrollment began in fall of 2019. All programs will be given access to the Wellness Toolkit in early 2023.
We have worked hard on our interventions. How can we participate in the research?
We at the SECOND Trial are supportive of collaborative research efforts. If you contribute novel interventions to the Wellness Toolkit and serve as coaches or topical experts for programs that decide to implement them, you may participate in scholarship in the following way: We can analyze and give you ABSITE survey results to write up for the subset of programs that choose your intervention from the Wellness Toolkit. (Our data use agreements prohibit us from sharing the raw data.) Of course, then your metrics are limited to the ones that are already measured in the ABSITE survey.
We envisioned the Wellness Toolkit to be an interactive application, to which programs can add their tips, tricks, and experiences as they begin implementing the interventions that you contributed. In this way, the SECOND Trial weaves together the best pieces from all programs to maximize our collective impact on resident well-being.