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 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 also closely track the wellness changes 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, and the American Board of Surgery. The Association of American Medical Colleges and the Society of Surgical Chairs have joined this trial as well. 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 transferring 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 (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 conclude in August 2019. All programs will receive data and the Wellness Toolkit in fall 2019. All programs will be given access to the Wellness Toolkit in early 2022.
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 ways:
(1) 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.
(2) You may gather your own data on metrics of your choosing from the programs working on your intervention. As a coach, we would anticipate you would have regular contact with them.
(3) Wherever possible, we plan to credit the Surgical Education Trials Collaborative as an author of all SECOND Trial manuscripts, so individuals who contribute can be acknowledged as co-authors.
We envision the Wellness Toolkit as an electronically available living document, to which programs will add their tips, tricks, and experiences as they begin implementing the interventions that you contributed. In this way, the SECOND Trial will weave together the best pieces from all programs to maximize our collective impact on resident well-being.