|Flexibility In duty hour Requirements for Surgical Trainees Trial|
|"the FIRST trial"|
Question: Does my hospital have to participate in ACS NSQIP in order to enroll in the study or will another surgical quality improvement program be ok?
Answer: Your hospital must participate in ACS NSQIP in order to participate in the ABS resident duty hour study so that we are all using the same data collection platform and data definitions.
Question: Which hospitals are eligible to participate?
Answer: If your Residency Program approves the study, then the sponsoring institution (primary hospital) and any affiliate hospitals can participate in the study. However, if your Residency Program does not approve participation in the study, then affiliate hospitals cannot participate in the study.
Question: We send our residents to 6 hospitals. What if some of the hospitals are not in ACS NSQIP?
Answer: As long as your Residency Program approves the study, then any of the 6 hospitals that participate in ACS NSQIP can join the study. The hospitals that are not in ACS NSQIP cannot join the study. However, the waiver from the ACGME covers the Residency Program, so if your residency program is assigned to the flexible duty hours arm (intervention), then your residents will be able to follow the flexible duty hour rules even at the non-NSQIP hospitals.
Question: We send our residents to 6 hospitals. If all hospitals choose to participate in the study, will all the hospitals be assigned to the same study arm?
Answer: Yes. Randomization will occur at the Residency Program level so programs will only have one set of rules for their residents at all of their hospitals.
Question: What do we do if residents from other specialties (i.e., orthopedics, OB/Gyn, Anesthesiology, Emergency Medicine) or other hospitals (i.e., visiting residents) are on a general surgery rotation with flexible duty hours (intervention arm)?
Answer: To ensure uniformity in patient care,
non-general surgery and visiting residents will be subject to the same duty hour requirements (intervention or control arm) that
are applied to general surgery residents when rotating on general surgery services. Residents from other specialties and hospitals
will be subject to the study arm duty hour requirements while rotating on a general surgery service. It is recommended that in
these situations program directors reach out to discuss these changes with their fellow program directors in other specialties/programs
to explain the duty hour changes these residents may face on during their general surgery rotation.
The ACGME anticipates that the ACGME and involved RRCs will need to 'cut some slack' for those other programs from which rotators originate when it comes to interpretation of the duty hours portion of the ACGME Annual Resident Survey. That is not to say that an RRC might not ask for clarifying information about a non-compliant survey. However, if they are asked and respond that the aberration resulted from their residents rotating on a general surgery service with duty hours liberalized by the study, then they would get a 'pass.'
Question: Our main teaching hospital (sponsoring institution) is not in ACS NSQIP, but we send a lot of our residents to an affiliate hospital that is in ACS NSQIP? Can our program enroll in the study?
Answer: Yes. If you have an affiliate hospital where you send residents for rotations and that hospital is in ACS NSQIP, then that hospital could enroll. If that hospital got randomized to the intervention arm (flexible duty hours), then the entire Residency Program (all hospitals) would receive the ACGME waiver (including your currently non-NSQIP main teaching hospital).
Question: Are VA hospitals eligible for this study?
Answer: No. VA hospitals are not eligible for this study. However, the waiver from the ACGME covers the Residency Program, so if your residency program is assigned to the flexible duty hours arm, then your residents will be able to follow the flexible duty hour rules even when rotating through an affiliated VA hospital.
Question: Are hospitals in New York able to participate in this study given the state laws regulating resident work hours?
Answer: Due to the multiple statues governing the duty hour restrictions in New York State, we were unable to get a waiver for participation from the Health commissioner. Therefore, hospitals in New York will be unable to participate in the FIRST Trial.
Question: Do we need to get Institutional Review Board (IRB) approval from our institution?
Answer: No. This study has been reviewed by Northwestern University’s IRB and has been deemed “exempt” research because the intervention is at the hospital level (no patients to consent), no patient- or resident-identifiable data are being collected, and the data being analyzed will have already been collected for the purposes of ACS NSQIP.
Question: Should we seek approval from our Designated Institutional Official (DIO)?
Answer: Yes, DIO approval is needed.
Question: We have an integrated Vascular Surgery residency program. Can our vascular residency program participate?
Answer: No. Only General Surgery residency programs can participate. However, if your General Surgery residency program is randomized to the flexible duty hours arm, then integrated Vascular Surgery residents will follow the flexible duty hours while they are rotating on General Surgery services. The same applies for any other integrated residencies (e.g., cardiac, plastics, etc.).
Question: Is participation in one of the webinars required to participate in the study?
Answer: No. You may enroll in the study without participating in the webinars.
Question: When will we be notified regarding which study arm we will be assigned?
Answer: Study Arm assignments will be made no later than March 31, 2014 to allow plenty of time for modifying rotation and call schedules prior to the 2014-2015 academic residency year.
Further Clarification surrounding who is covered by ACGME Waiver