SafetyiCOMPARENCT02274818
Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education.
A study testing Flexible Duty Hour Schedule in people with Safety and Education, Medical, run by University of Pennsylvania.
Trial summary
The investigators are conducting a cluster randomized trial in a sample of 63 internal medicine (IM) training programs that are randomly assigned to either the current duty hour standards or less restricted flexible duty hour standards. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety, Education, Medical, Sleep
- What is being tested?
- Flexible Duty Hour Schedule
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to 30 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current internal medicine program in the United States Continued Accreditation status with the ACGME - Program director agrees to:
- Randomization to one of the two study arms.
- Develop, and share with the study team, institutional duty hour schedules and regulatory policies/procedures that will ensure adherence to, and enforcement of, the duty hour regulations that apply to their study arm
- Allow access and analysis of de-identified resident duty hour adherence data/logs, call schedules, and rotation schedules to the Study Team.
- Participate, and encourage trainee participation at your institution, in beginning and end of year iCOMPARE surveys.
Who cannot join
- The investigators excluded 119 programs that comprise the bottom 50% in resident-to-bed ratio and the bottom 25% in patient volume related to the diagnoses by which the patient population will be selected for evaluation of safety outcomes.
- Within the 260 programs that remain, the investigators excluded the 65 in the lowest quartile of program size to ensure we can feasibly obtain sufficient trainee measurements.
- The 195 remaining programs are eligible for inclusion.
- The investigators have also excluded children and VA hospitals.
About this study
Official title: Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE).
The investigators are conducting a cluster randomized trial in a sample of 63 internal medicine (IM) training programs that are randomly assigned to either the current duty hour standards or less restricted flexible duty hour standards.
The trial includes a main protocol in which all randomized IM programs participate and two substudies. "Time and Motion" and "Sleep and Alertness", each conducted at a subset of IM programs and focusing on more detailed data collection at the intern level.
The main protocol will examine patient safety and costs as well as quality of education. The "Time and Motion" substudy examines additional educational outcomes. The "Sleep and Alertness" substudy examines intern sleep time and alertness.
Read the detailed description
Title: Sleep duration (hours of sleep) as measured with an actigraph Time frame: Measured daily for 14 days
Title: Behavioral alertness as measured with Psychomotor vigilance test Time frame: Measured daily for 14 days
Title: Self perceived sleepiness as measured by the Karolinska Sleepiness Score Time frame: Measured daily for 14 days
Title: Time (hours per day) spent in direct patient care Description: Time spent in direct patient care over 2-4 wks as measured by a trained observer shadowing the intern Time frame: measured daily over 2-4 wks
Title: Trainee satisfaction with education Description: Self-reported satisfaction with education as assessed thru survey questions Time frame: measured at baseline and at end of intervention year
Title: Program director satisfaction with trainee education Description: Self-reported satisfaction with trainee education as assessed thru survey questions Time frame: measured at baseline and end of intervention year
Patient safety and costs:
Title: Total costs of patient care as measured by total Medicare payments Time frame: Measured over year of trial
- Conditions
- Safety, Education, Medical, Sleep
- Being tested
- Flexible Duty Hour Schedule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible Duty Hour ScheduleBehavioural
IM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules:
- No more than 80 hours of work per week (when averaged over 4 weeks)
- 1 day off in 7 (when averaged over 4 weeks)
- In-house call no more frequently than every 3rd night (when averaged over 4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Standard Duty Hour Schedule | No intervention | IM programs randomized to the currently mandated duty 16 hour standards (maximum work duration of 16 hours for interns and 28 hours for PGY2-3); this schedule may involve night float. |
| Flexible Duty Hour Schedule | Experimental | IM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules:
* No more than 80 hours of work per week (when averaged over 4 weeks)
* 1 day off in 7 (when averaged over 4 weeks)
* In-house call no more frequently than every 3rd night (when averaged over 4 weeks) Receives: Behavioral: Flexible Duty Hour Schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
The difference between 30-day mortality rate in the trial year minus the 30-day mortality rate in the pretrial year
Measured: 12 months
Secondary outcomes (8)
Rate of prolonged length of stay
Prolonged length of stay as measured by Medicare data
Measured: 12 months
Total costs of patient care
Total costs of patient care as measured by total Medicare payments
Measured: 12 months
Sleep duration (hours of sleep)
Sleep duration (hours of sleep) as measured with an actigraph
Measured: Measured daily for 14 days
Behavioral alertness
Behavioral alertness as measured with Psychomotor vigilance test
Measured: Measured daily for 14 days
Self perceived sleepiness
Self perceived sleepiness as measured by the Karolinska Sleepiness Score
Measured: Measured daily for 14 days
Time (hours per day) spent in direct patient care
Time spent in direct patient care over 2-4 wks as measured by a trained observer shadowing the intern
Measured: measured daily over 2-4 wks
Trainee satisfaction with education
Self-reported satisfaction with education as assessed thru survey questions
Measured: measured at baseline and at end of intervention year
Program director satisfaction with trainee education
Self-reported satisfaction with trainee education as assessed thru survey questions
Measured: measured at baseline and end of intervention year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI), Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- David Asch, MD, MBA, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274818
- Sponsor's protocol ID
- IRB00051227
- Other IDs
- 1U01HL125388, 1U01HL126088
- Acronym
- iCOMPARE
- Status last verified
- Sep 2020
- First submitted
- 20 Oct 2014
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chaiyachati KH, Shea JA, Asch DA, Liu M, Bellini LM, Dine CJ, Sternberg AL, Gitelman Y, Yeager AM, Asch JM, Desai SV. Assessment of Inpatient Time Allocation Among First-Year Internal Medicine Residents Using Time-Motion Observations. JAMA Intern Med. 2019 Jun 1;179(6):760-767. doi: 10.1001/jamainternmed.2019.0095.
PubMed 30985861Basner M, Asch DA, Shea JA, Bellini LM, Carlin M, Ecker AJ, Malone SK, Desai SV, Sternberg AL, Tonascia J, Shade DM, Katz JT, Bates DW, Even-Shoshan O, Silber JH, Small DS, Volpp KG, Mott CG, Coats S, Mollicone DJ, Dinges DF; iCOMPARE Research Group. Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med. 2019 Mar 7;380(10):915-923. doi: 10.1056/NEJMoa1810641.
PubMed 30855741Silber JH, Bellini LM, Shea JA, Desai SV, Dinges DF, Basner M, Even-Shoshan O, Hill AS, Hochman LL, Katz JT, Ross RN, Shade DM, Small DS, Sternberg AL, Tonascia J, Volpp KG, Asch DA; iCOMPARE Research Group. Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules. N Engl J Med. 2019 Mar 7;380(10):905-914. doi: 10.1056/NEJMoa1810642.
PubMed 30855740Shea JA, Silber JH, Desai SV, Dinges DF, Bellini LM, Tonascia J, Sternberg AL, Small DS, Shade DM, Katz JT, Basner M, Chaiyachati KH, Even-Shoshan O, Bates DW, Volpp KG, Asch DA; iCOMPARE Research Group. Development of the individualised Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial: a protocol summary of a national cluster-randomised trial of resident duty hour policies in internal medicine. BMJ Open. 2018 Sep 21;8(9):e021711. doi: 10.1136/bmjopen-2018-021711.
PubMed 30244209Desai SV, Asch DA, Bellini LM, Chaiyachati KH, Liu M, Sternberg AL, Tonascia J, Yeager AM, Asch JM, Katz JT, Basner M, Bates DW, Bilimoria KY, Dinges DF, Even-Shoshan O, Shade DM, Silber JH, Small DS, Volpp KG, Shea JA; iCOMPARE Research Group. Education Outcomes in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med. 2018 Apr 19;378(16):1494-1508. doi: 10.1056/NEJMoa1800965. Epub 2018 Mar 20.
PubMed 29557719
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE).
- ClinicalTrials.gov ID
- NCT02274818
- Acronym / sponsor ID
- iCOMPARE / IRB00051227
- Conditions
- Safety, Education, Medical, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI), Brigham and Women's Hospital
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 24 Oct 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.
The investigators are conducting a cluster randomized trial in a sample of 63 internal medicine (IM) training programs that are randomly assigned to either the current duty hour standards or less restricted flexible duty hour standards.
The trial includes a main protocol in which all randomized IM programs participate and two substudies. "Time and Motion" and "Sleep and Alertness", each conducted at a subset of IM programs and focusing on more detailed data collection at the intern level.
The main protocol will examine patient safety and costs as well as quality of education. The "Time and Motion" substudy examines additional educational outcomes. The "Sleep and Alertness" substudy examines intern sleep time and alertness.
Detailed description
Title: Sleep duration (hours of sleep) as measured with an actigraph Time frame: Measured daily for 14 days
Title: Behavioral alertness as measured with Psychomotor vigilance test Time frame: Measured daily for 14 days
Title: Self perceived sleepiness as measured by the Karolinska Sleepiness Score Time frame: Measured daily for 14 days
Title: Time (hours per day) spent in direct patient care Description: Time spent in direct patient care over 2-4 wks as measured by a trained observer shadowing the intern Time frame: measured daily over 2-4 wks
Title: Trainee satisfaction with education Description: Self-reported satisfaction with education as assessed thru survey questions Time frame: measured at baseline and at end of intervention year
Title: Program director satisfaction with trainee education Description: Self-reported satisfaction with trainee education as assessed thru survey questions Time frame: measured at baseline and end of intervention year
Patient safety and costs:
Title: Total costs of patient care as measured by total Medicare payments Time frame: Measured over year of trial
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Duty Hour Schedule | No intervention | –IM programs randomized to the currently mandated duty 16 hour standards (maximum work duration of 16 hours for interns and 28 hours for PGY2-3); this schedule may involve night float. |
| Flexible Duty Hour Schedule | Experimental | Behavioral: Flexible Duty Hour ScheduleIM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules: * No more than 80 hours of work per week (when averaged over 4 weeks) * 1 day off in 7 (when averaged over 4 weeks) * In-house call no more frequently than every 3rd night (when averaged over 4 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current internal medicine program in the United States Continued Accreditation status with the ACGME - Program director agrees to:
Key exclusion criteria (4 listed)
- The investigators excluded 119 programs that comprise the bottom 50% in resident-to-bed ratio and the bottom 25% in patient volume related to the diagnoses by which the patient population will be selected for evaluation of safety outcomes.
- Within the 260 programs that remain, the investigators excluded the 65 in the lowest quartile of program size to ensure we can feasibly obtain sufficient trainee measurements.
- The 195 remaining programs are eligible for inclusion.
- The investigators have also excluded children 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 Hour ScheduleIM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules: * No more than 80 hours of work per week (when averaged over 4 weeks) * 1 day off in 7 (when averaged over 4 weeks) * In-house call no more frequently than every 3rd night (when averaged over 4 weeks) | Behavioural | Flexible Duty Hour Schedule |
Primary outcome
30-day mortality
Time frame: 12 months
The difference between 30-day mortality rate in the trial year minus the 30-day mortality rate in the pretrial year
8 secondary outcomes
Rate of prolonged length of stay
Time frame: 12 months
Total costs of patient care
Time frame: 12 months
Sleep duration (hours of sleep)
Time frame: Measured daily for 14 days
Behavioral alertness
Time frame: Measured daily for 14 days
Self perceived sleepiness
Time frame: Measured daily for 14 days
Time (hours per day) spent in direct patient care
Time frame: measured daily over 2-4 wks
Trainee satisfaction with education
Time frame: measured at baseline and at end of intervention year
Program director satisfaction with trainee education
Time frame: measured at baseline and end of intervention year
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 4 Sep 2020.
- Derived from this study: PubMed 30985861Chaiyachati KH, Shea JA, Asch DA, Liu M, Bellini LM, Dine CJ, Sternberg AL, Gitelman Y, Yeager AM, Asch JM, Desai SV. Assessment of Inpatient Time Allocation Among First-Year Internal Medicine Residents Using Time-Motion Observations. JAMA Intern Med. 2019 Jun 1;179(6):760-767. doi: 10.1001/jamainternmed.2019.0095.
- Derived from this study: PubMed 30855741Basner M, Asch DA, Shea JA, Bellini LM, Carlin M, Ecker AJ, Malone SK, Desai SV, Sternberg AL, Tonascia J, Shade DM, Katz JT, Bates DW, Even-Shoshan O, Silber JH, Small DS, Volpp KG, Mott CG, Coats S, Mollicone DJ, Dinges DF; iCOMPARE Research Group. Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med. 2019 Mar 7;380(10):915-923. doi: 10.1056/NEJMoa1810641.
- Derived from this study: PubMed 30855740Silber JH, Bellini LM, Shea JA, Desai SV, Dinges DF, Basner M, Even-Shoshan O, Hill AS, Hochman LL, Katz JT, Ross RN, Shade DM, Small DS, Sternberg AL, Tonascia J, Volpp KG, Asch DA; iCOMPARE Research Group. Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules. N Engl J Med. 2019 Mar 7;380(10):905-914. doi: 10.1056/NEJMoa1810642.
- Derived from this study: PubMed 30244209Shea JA, Silber JH, Desai SV, Dinges DF, Bellini LM, Tonascia J, Sternberg AL, Small DS, Shade DM, Katz JT, Basner M, Chaiyachati KH, Even-Shoshan O, Bates DW, Volpp KG, Asch DA; iCOMPARE Research Group. Development of the individualised Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial: a protocol summary of a national cluster-randomised trial of resident duty hour policies in internal medicine. BMJ Open. 2018 Sep 21;8(9):e021711. doi: 10.1136/bmjopen-2018-021711.
- Derived from this study: PubMed 29557719Desai SV, Asch DA, Bellini LM, Chaiyachati KH, Liu M, Sternberg AL, Tonascia J, Yeager AM, Asch JM, Katz JT, Basner M, Bates DW, Bilimoria KY, Dinges DF, Even-Shoshan O, Shade DM, Silber JH, Small DS, Volpp KG, Shea JA; iCOMPARE Research Group. Education Outcomes in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med. 2018 Apr 19;378(16):1494-1508. doi: 10.1056/NEJMoa1800965. Epub 2018 Mar 20.
- Individual participant dataSharing planned: No
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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.
David Asch, MD, MBA principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A study testing Flexible Duty Hour Schedule in people with Safety and Education, Medical, run by University of Pennsylvania.
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 5 inclusion and 4 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 4 Sep 2020. 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?
30-day mortality (time frame: 12 months). 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 NCT02274818, which also lists 5 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 4 Sep 2020.