Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT02274818
Status:
COMPLETED
Last Update Posted:
2020-09-04
First Post:
2014-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-22', 'size': 2046897, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-03T13:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2014-10-20', 'studyFirstSubmitQcDate': '2014-10-23', 'lastUpdatePostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': '12 months', 'description': 'The difference between 30-day mortality rate in the trial year minus the 30-day mortality rate in the pretrial year'}], 'secondaryOutcomes': [{'measure': 'Rate of prolonged length of stay', 'timeFrame': '12 months', 'description': 'Prolonged length of stay as measured by Medicare data'}, {'measure': 'Total costs of patient care', 'timeFrame': '12 months', 'description': 'Total costs of patient care as measured by total Medicare payments'}, {'measure': 'Sleep duration (hours of sleep)', 'timeFrame': 'Measured daily for 14 days', 'description': 'Sleep duration (hours of sleep) as measured with an actigraph'}, {'measure': 'Behavioral alertness', 'timeFrame': 'Measured daily for 14 days', 'description': 'Behavioral alertness as measured with Psychomotor vigilance test'}, {'measure': 'Self perceived sleepiness', 'timeFrame': 'Measured daily for 14 days', 'description': 'Self perceived sleepiness as measured by the Karolinska Sleepiness Score'}, {'measure': 'Time (hours per day) spent in direct patient care', 'timeFrame': 'measured daily over 2-4 wks', 'description': 'Time spent in direct patient care over 2-4 wks as measured by a trained observer shadowing the intern'}, {'measure': 'Trainee satisfaction with education', 'timeFrame': 'measured at baseline and at end of intervention year', 'description': 'Self-reported satisfaction with education as assessed thru survey questions'}, {'measure': 'Program director satisfaction with trainee education', 'timeFrame': 'measured at baseline and end of intervention year', 'description': 'Self-reported satisfaction with trainee education as assessed thru survey questions'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Safety', 'Education, Medical', 'Sleep']}, 'referencesModule': {'references': [{'pmid': '30985861', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30855741', 'type': 'DERIVED', 'citation': 'Basner 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.'}, {'pmid': '30855740', 'type': 'DERIVED', 'citation': 'Silber 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.'}, {'pmid': '30244209', 'type': 'DERIVED', 'citation': 'Shea 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.'}, {'pmid': '29557719', 'type': 'DERIVED', 'citation': 'Desai 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.', 'detailedDescription': 'Title: Sleep duration (hours of sleep) as measured with an actigraph Time frame: Measured daily for 14 days\n\nTitle: Behavioral alertness as measured with Psychomotor vigilance test Time frame: Measured daily for 14 days\n\nTitle: Self perceived sleepiness as measured by the Karolinska Sleepiness Score Time frame: Measured daily for 14 days\n\nTitle: 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\n\nTitle: 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\n\nTitle: 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\n\nPatient safety and costs:\n\nTitle: Total costs of patient care as measured by total Medicare payments Time frame: Measured over year of trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current internal medicine program in the United States Continued Accreditation status with the ACGME - Program director agrees to:\n\n 1. Randomization to one of the two study arms.\n 2. 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\n 3. Allow access and analysis of de-identified resident duty hour adherence data/logs, call schedules, and rotation schedules to the Study Team.\n 4. Participate, and encourage trainee participation at your institution, in beginning and end of year iCOMPARE surveys.\n\nExclusion Criteria:\n\n* 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.\n* 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.\n* The 195 remaining programs are eligible for inclusion.\n* The investigators have also excluded children and VA hospitals.'}, 'identificationModule': {'nctId': 'NCT02274818', 'acronym': 'iCOMPARE', 'briefTitle': 'Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education.', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE).', 'orgStudyIdInfo': {'id': 'IRB00051227'}, 'secondaryIdInfos': [{'id': '1U01HL125388', 'link': 'https://reporter.nih.gov/quickSearch/1U01HL125388', 'type': 'NIH'}, {'id': '1U01HL126088', 'link': 'https://reporter.nih.gov/quickSearch/1U01HL126088', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Duty Hour Schedule', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Flexible Duty Hour Schedule', 'description': 'IM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules:\n\n* No more than 80 hours of work per week (when averaged over 4 weeks)\n* 1 day off in 7 (when averaged over 4 weeks)\n* In-house call no more frequently than every 3rd night (when averaged over 4 weeks)', 'interventionNames': ['Behavioral: Flexible Duty Hour Schedule']}], 'interventions': [{'name': 'Flexible Duty Hour Schedule', 'type': 'BEHAVIORAL', 'description': 'IM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules:\n\n* No more than 80 hours of work per week (when averaged over 4 weeks)\n* 1 day off in 7 (when averaged over 4 weeks)\n* In-house call no more frequently than every 3rd night (when averaged over 4 weeks)', 'armGroupLabels': ['Flexible Duty Hour Schedule']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Asch, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}