Patient SafetyFIRSTNCT02050789
Flexibility In Duty Hour Requirements for Surgical Trainees Trial - "the FIRST Trial"
A study testing flexible duty hours in people with Patient Safety and Resident Work Hours, run by Northwestern University.
Trial summary
Resident duty hour requirements in the U.S. are still evolving as stakeholders continue to debate how best to (re)structure postgraduate medical education. There is concern that current restrictions may be detrimental to patient care and resident training. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patient Safety, Resident Work Hours
- What is being tested?
- flexible duty hours
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to 30 Jun 2017
- 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
- General Surgery Residency Programs participating in ACS NSQIP
Who cannot join
- Childrens' and VA Hospitals
About this study
Official title: Allowing Flexibility in Surgical Resident Duty Hours Trial
Resident duty hour requirements in the U.S. are still evolving as stakeholders continue to debate how best to (re)structure postgraduate medical education.
There is concern that current restrictions may be detrimental to patient care and resident training. To investigate these issues, the investigators will be conducting a one-year, prospective randomized trial to examine how flexibility of duty hour requirements affects patient care when compared to current resident duty hour requirements. Further information about the study is available on the FIRST Trial website http://www.thefirsttrial.org/.
Read the detailed description
Residency programs will be randomized to either (1) an intervention arm that eliminates several Accreditation Council for Graduate Medical Education (ACGME) duty hour requirements or (2) to a usual care arm where programs will continue adhering to current ACGME requirements. Programs in the intervention arm will be granted a waiver from current duty hour requirements by the ACGME and allowed to eliminate all resident duty hour rules with the following exceptions: Duty hours limited to 80 hours/week averaged over 4 weeks, minimum of one free day (no duty)/week averaged over 4 weeks, may not take in-house call more frequently than every 3rd night, averaged over 4 weeks, allowed to increase duty requirement flexibility for chief residents. The intent of the intervention arm is to allow flexibility in surgical resident duty hours and improve continuity of care. Subsequently, the investigators will compare multiple postoperative outcomes between the two study arms using data collected through the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP). The results of this study will provide high-quality empirical evidence upon which to base resident duty hour requirements in the future.
Updated April 1, 2014
Detailed statistical analysis plan available on the FIRST Trial website. http://www.thefirsttrial.org/Approval/Approval
A listing of the 152 ACS-NSQIP hospitals that have elected to participate in the FIRST Trial is available on the FIRST Trial website. http://www.thefirsttrial.org/Hospitals/Hospitals
Updated July 14, 2014
Post-Randomization documents available for control and intervention arms on FIRST Trial website.
http://www.thefirsttrial.org/PostRandomization/PostRandomization
Updated August 2014
'FIRST Trial-Policies \& Procedures Survey for Program Directors' survey administered to general surgery program directors via Survey Monkey.
Updated January 2015
Resident survey regarding duty hour policies and procedures administered at the end of the annual ABS In-Training Examination (ABSITE®).
Updated April 1, 2015
The Data Safety Monitoring Board (DSMB) was convened March 10, 2015 to review the results of planned interim analysis. After review, they voted to allow the FIRST Trial to continue. All other aspects of the trial are on track.
Updated May 24, 2016
Results from the study were released February 2, 2016 and the study has been extended for an additional year, through the 2016-2017 academic year.
Additional programs were enrolled in the one-year extension study.
March 10, 2017
The Accreditation Council for Graduate Medical Education (ACGME) released a final set of revisions to the professional standards all accredited US residency and fellowship programs follow in preparing today's physicians for a lifetime of practice. The new model also directly addresses requests from medical educators and residents by recognizing the risk of burnout and depression for physicians. Programs and institutions will be responsible for prioritizing physician well-being, ensuring protected time with patients, minimizing non-physician obligations, and ensuring that residents have the opportunity to access medical and dental care.
The total number of clinical and educational hours for residents has not changed. Starting the 2017-2018 academic year, the standards require that all programs and residents adhere to the maximum limits averaged over four weeks:
- a maximum of 80 hours per week
- one day free from clinical experience or education in seven
- in-house call no more frequent than every third night
- a maximum of 24 continuous work hours for all residents.
Updated September 12, 2017
Resident survey data collected with the 2016 and 2017 ABSITE Survey were collected and analyzed. Topics that emerged for further qualitative and quantitative analysis are as follows:
- Gender differences in resident outcomes
- Burnout and psychological wellbeing among residents
- Coercion and the decision to stay longer shifts within the flexible arm
- Needle stick and motor vehicle accident rates among US General Surgery residents
- Residency preparation (readiness) and the effects on burnout and wellbeing
- Conditions
- Patient Safety, Resident Work Hours
- Being tested
- flexible duty hours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible duty hoursBehavioural
Also called Waiver from current duty hour requirements by the ACGME., Allowed to eliminate all resident duty hour rules except:, Duty hours limited to 80 hrs/week averaged over 4 weeks., Min of 1 free day (no duty)/week averaged over 4 weeks.
If a hospital is assigned to the intervention arm, all categorical and preliminary general surgery residents in that general surgery program will switch to the flexible duty hours while at an enrolled hospital.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Arm | No intervention | Programs will continue adhering to current ACGME requirements. |
| Intervention Arm | Experimental | The intent of the intervention arm is to allow flexibility in surgical resident duty hours and improve continuity of care. Receives: Behavioral: flexible duty hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or Serious Morbidity
The primary outcome for the trial is a composite measure of Death or Serious Morbidity.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJul 2014
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern 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, Northwestern University
- Investigators
- Karl Y. Bilimoria, MD MS, Principal investigator, Northwestern University, American College of Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050789
- Sponsor's protocol ID
- FIRST Trial
- Acronym
- FIRST
- Status last verified
- Sep 2017
- First submitted
- 24 Jan 2014
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saadat LV, Dahlke AR, Rajaram R, Kreutzer L, Love R, Odell DD, Bilimoria KY, Yang AD. Program Director Perceptions of Surgical Resident Training and Patient Care under Flexible Duty Hour Requirements. J Am Coll Surg. 2016 Jun;222(6):1098-105. doi: 10.1016/j.jamcollsurg.2016.03.026. Epub 2016 Apr 4.
PubMed 27234632Bilimoria KY, Chung JW, Hedges LV, Dahlke AR, Love R, Cohen ME, Hoyt DB, Yang AD, Tarpley JL, Mellinger JD, Mahvi DM, Kelz RR, Ko CY, Odell DD, Stulberg JJ, Lewis FR. National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training. N Engl J Med. 2016 Feb 25;374(8):713-27. doi: 10.1056/NEJMoa1515724. Epub 2016 Feb 2.
PubMed 26836220Bilimoria KY, Chung JW, Hedges LV, Dahlke AR, Love R, Cohen ME, Tarpley J, Mellinger J, Mahvi DM, Kelz RR, Ko CY, Hoyt DB, Lewis FH. Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Protocol: A National Cluster-Randomized Trial of Resident Duty Hour Policies. JAMA Surg. 2016 Mar;151(3):273-81. doi: 10.1001/jamasurg.2015.4990.
PubMed 26720622
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allowing Flexibility in Surgical Resident Duty Hours Trial
- ClinicalTrials.gov ID
- NCT02050789
- Acronym / sponsor ID
- FIRST / FIRST Trial
- Conditions
- Patient Safety, Resident Work Hours
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- American College of Surgeons, American Board of Surgery, Accreditation Council for Graduate Medical Education
- Study start
- Jul 2014
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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.
Resident duty hour requirements in the U.S. are still evolving as stakeholders continue to debate how best to (re)structure postgraduate medical education.
There is concern that current restrictions may be detrimental to patient care and resident training. To investigate these issues, the investigators will be conducting a one-year, prospective randomized trial to examine how flexibility of duty hour requirements affects patient care when compared to current resident duty hour requirements. Further information about the study is available on the FIRST Trial website http://www.thefirsttrial.org/.
Detailed description
Residency programs will be randomized to either (1) an intervention arm that eliminates several Accreditation Council for Graduate Medical Education (ACGME) duty hour requirements or (2) to a usual care arm where programs will continue adhering to current ACGME requirements. Programs in the intervention arm will be granted a waiver from current duty hour requirements by the ACGME and allowed to eliminate all resident duty hour rules with the following exceptions: Duty hours limited to 80 hours/week averaged over 4 weeks, minimum of one free day (no duty)/week averaged over 4 weeks, may not take in-house call more frequently than every 3rd night, averaged over 4 weeks, allowed to increase duty requirement flexibility for chief residents. The intent of the intervention arm is to allow flexibility in surgical resident duty hours and improve continuity of care. Subsequently, the investigators will compare multiple postoperative outcomes between the two study arms using data collected through the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP). The results of this study will provide high-quality empirical evidence upon which to base resident duty hour requirements in the future.
Updated April 1, 2014
Detailed statistical analysis plan available on the FIRST Trial website. http://www.thefirsttrial.org/Approval/Approval
A listing of the 152 ACS-NSQIP hospitals that have elected to participate in the FIRST Trial is available on the FIRST Trial website. http://www.thefirsttrial.org/Hospitals/Hospitals
Updated July 14, 2014
Post-Randomization documents available for control and intervention arms on FIRST Trial website.
http://www.thefirsttrial.org/PostRandomization/PostRandomization
Updated August 2014
'FIRST Trial-Policies \& Procedures Survey for Program Directors' survey administered to general surgery program directors via Survey Monkey.
Updated January 2015
Resident survey regarding duty hour policies and procedures administered at the end of the annual ABS In-Training Examination (ABSITE®).
Updated April 1, 2015
The Data Safety Monitoring Board (DSMB) was convened March 10, 2015 to review the results of planned interim analysis. After review, they voted to allow the FIRST Trial to continue. All other aspects of the trial are on track.
Updated May 24, 2016
Results from the study were released February 2, 2016 and the study has been extended for an additional year, through the 2016-2017 academic year.
Additional programs were enrolled in the one-year extension study.
March 10, 2017
The Accreditation Council for Graduate Medical Education (ACGME) released a final set of revisions to the professional standards all accredited US residency and fellowship programs follow in preparing today's physicians for a lifetime of practice. The new model also directly addresses requests from medical educators and residents by recognizing the risk of burnout and depression for physicians. Programs and institutions will be responsible for prioritizing physician well-being, ensuring protected time with patients, minimizing non-physician obligations, and ensuring that residents have the opportunity to access medical and dental care.
The total number of clinical and educational hours for residents has not changed. Starting the 2017-2018 academic year, the standards require that all programs and residents adhere to the maximum limits averaged over four weeks:
- a maximum of 80 hours per week
- one day free from clinical experience or education in seven
- in-house call no more frequent than every third night
- a maximum of 24 continuous work hours for all residents.
Updated September 12, 2017
Resident survey data collected with the 2016 and 2017 ABSITE Survey were collected and analyzed. Topics that emerged for further qualitative and quantitative analysis are as follows:
- Gender differences in resident outcomes
- Burnout and psychological wellbeing among residents
- Coercion and the decision to stay longer shifts within the flexible arm
- Needle stick and motor vehicle accident rates among US General Surgery residents
- Residency preparation (readiness) and the effects on burnout and wellbeing
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Arm | No intervention | –Programs will continue adhering to current ACGME requirements. |
| Intervention Arm | Experimental | Behavioral: flexible duty hoursThe intent of the intervention arm is to allow flexibility in surgical resident duty hours and improve continuity of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- General Surgery Residency Programs participating in ACS NSQIP
Key exclusion criteria (1 listed)
- Childrens' and VA Hospitals
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 |
|---|---|---|
| flexible duty hoursAlso: Waiver from current duty hour requirements by the ACGME., Allowed to eliminate all resident duty hour rules except:, Duty hours limited to 80 hrs/week averaged over 4 weeks., Min of 1 free day (no duty)/week averaged over 4 weeks.If a hospital is assigned to the intervention arm, all categorical and preliminary general surgery residents in that general surgery program will switch to the flexible duty hours while at an enrolled hospital. | Behavioural | Intervention Arm |
Primary outcome
Death or Serious Morbidity
Time frame: 30 days
The primary outcome for the trial is a composite measure of Death or Serious Morbidity.
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 13 Sep 2017.
- Derived from this study: PubMed 27234632Saadat LV, Dahlke AR, Rajaram R, Kreutzer L, Love R, Odell DD, Bilimoria KY, Yang AD. Program Director Perceptions of Surgical Resident Training and Patient Care under Flexible Duty Hour Requirements. J Am Coll Surg. 2016 Jun;222(6):1098-105. doi: 10.1016/j.jamcollsurg.2016.03.026. Epub 2016 Apr 4.
- Derived from this study: PubMed 26836220Bilimoria KY, Chung JW, Hedges LV, Dahlke AR, Love R, Cohen ME, Hoyt DB, Yang AD, Tarpley JL, Mellinger JD, Mahvi DM, Kelz RR, Ko CY, Odell DD, Stulberg JJ, Lewis FR. National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training. N Engl J Med. 2016 Feb 25;374(8):713-27. doi: 10.1056/NEJMoa1515724. Epub 2016 Feb 2.
- Derived from this study: PubMed 26720622Bilimoria KY, Chung JW, Hedges LV, Dahlke AR, Love R, Cohen ME, Tarpley J, Mellinger J, Mahvi DM, Kelz RR, Ko CY, Hoyt DB, Lewis FH. Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Protocol: A National Cluster-Randomized Trial of Resident Duty Hour Policies. JAMA Surg. 2016 Mar;151(3):273-81. doi: 10.1001/jamasurg.2015.4990.
- Flexibility In duty hour Requirements for Surgical Trainees Trial - "The FIRST Trial"Link provided by the sponsor.
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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.
Karl Y. Bilimoria, MD MS principal investigator
Northwestern University, American College of Surgeons
Questions about this trial
What is this clinical trial studying?
A study testing flexible duty hours in people with Patient Safety and Resident Work Hours, run by Northwestern University.
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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Death or Serious Morbidity (time frame: 30 days). 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 NCT02050789, which also lists 3 linked publications.
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 13 Sep 2017.