Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT03597932
Status:
UNKNOWN
Last Update Posted:
2018-07-24
First Post:
2018-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Handover Checklist of Anesthesia Care Improves Outcomes Among Patients Undergoing Major Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3342}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-22', 'studyFirstSubmitDate': '2018-06-22', 'studyFirstSubmitQcDate': '2018-07-22', 'lastUpdatePostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of a composite of all-cause death, hospital readmission, or major postoperative complications', 'timeFrame': '30 days', 'description': 'The primary outcome that will be measured is a composite of all-cause death, hospital readmission, or major postoperative complications, all within 30 days post surgery'}], 'secondaryOutcomes': [{'measure': 'Incidence of 7 day-, 30 day-, 90 day- and inhospital mortality', 'timeFrame': '7/30/90 day', 'description': '7/30/90-day mortality, inhospital mortality'}, {'measure': 'Incidence of major complications', 'timeFrame': '30 days', 'description': 'Postoperative major complications, defined by International Classification of Diseases, Tenth Revision (ICD-10) diagnostic codes'}, {'measure': 'Incidence of ICU admission post surgery', 'timeFrame': '30 days', 'description': 'Incidence of postoperative intensive care unit (ICU) admission, ,within 30 days post surgery'}, {'measure': 'The time of hospital length of stay (LOS)', 'timeFrame': 'up to 30 days', 'description': 'Hospital length of stay (LOS)'}, {'measure': 'Incidence of emergency department (ED) visits', 'timeFrame': '90 days', 'description': 'Emergency department (ED) visits within 90 days of the index surgery'}, {'measure': 'Any medical cost during hospital stay', 'timeFrame': 'up to 90 days', 'description': 'Any medical cost during hospital stay'}, {'measure': 'Ventilation time within postoperative 30 days', 'timeFrame': 'Up to 30 days', 'description': 'Ventilation time within postoperative 30 days'}, {'measure': 'Anaesthetic resuscitation time', 'timeFrame': 'Up to 24 hours', 'description': 'Anaesthetic resuscitation time after the surgery is completed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['major surgery', 'ansethesia care', 'postoperative complication', 'handover checklist', 'anesthesiologist burnout'], 'conditions': ['Anesthesia', 'Surgery--Complications', 'Burnout, Professional']}, 'referencesModule': {'references': [{'pmid': '29318277', 'type': 'RESULT', 'citation': 'Jones PM, Cherry RA, Allen BN, Jenkyn KMB, Shariff SZ, Flier S, Vogt KN, Wijeysundera DN. Association Between Handover of Anesthesia Care and Adverse Postoperative Outcomes Among Patients Undergoing Major Surgery. JAMA. 2018 Jan 9;319(2):143-153. doi: 10.1001/jama.2017.20040.'}, {'pmid': '29309320', 'type': 'RESULT', 'citation': 'Li H, Zuo M, Gelb AW, Zhang B, Zhao X, Yao D, Xia D, Huang Y. Chinese Anesthesiologists Have High Burnout and Low Job Satisfaction: A Cross-Sectional Survey. Anesth Analg. 2018 Mar;126(3):1004-1012. doi: 10.1213/ANE.0000000000002776.'}, {'pmid': '26575009', 'type': 'RESULT', 'citation': 'van der Wal RA, Bucx MJ, Hendriks JC, Scheffer GJ, Prins JB. Psychological distress, burnout and personality traits in Dutch anaesthesiologists: A survey. Eur J Anaesthesiol. 2016 Mar;33(3):179-86. doi: 10.1097/EJA.0000000000000375.'}, {'pmid': '22543067', 'type': 'RESULT', 'citation': 'Segall N, Bonifacio AS, Schroeder RA, Barbeito A, Rogers D, Thornlow DK, Emery J, Kellum S, Wright MC, Mark JB; Durham VA Patient Safety Center of Inquiry. Can we make postoperative patient handovers safer? A systematic review of the literature. Anesth Analg. 2012 Jul;115(1):102-15. doi: 10.1213/ANE.0b013e318253af4b. Epub 2012 Apr 27.'}, {'pmid': '25440620', 'type': 'RESULT', 'citation': 'Hudson CC, McDonald B, Hudson JK, Tran D, Boodhwani M. Impact of anesthetic handover on mortality and morbidity in cardiac surgery: a cohort study. J Cardiothorac Vasc Anesth. 2015 Feb;29(1):11-6. doi: 10.1053/j.jvca.2014.05.018. Epub 2014 Nov 24.'}, {'pmid': '25372088', 'type': 'RESULT', 'citation': "Starmer AJ, Spector ND, Srivastava R, West DC, Rosenbluth G, Allen AD, Noble EL, Tse LL, Dalal AK, Keohane CA, Lipsitz SR, Rothschild JM, Wien MF, Yoon CS, Zigmont KR, Wilson KM, O'Toole JK, Solan LG, Aylor M, Bismilla Z, Coffey M, Mahant S, Blankenburg RL, Destino LA, Everhart JL, Patel SJ, Bale JF Jr, Spackman JB, Stevenson AT, Calaman S, Cole FS, Balmer DF, Hepps JH, Lopreiato JO, Yu CE, Sectish TC, Landrigan CP; I-PASS Study Group. Changes in medical errors after implementation of a handoff program. N Engl J Med. 2014 Nov 6;371(19):1803-12. doi: 10.1056/NEJMsa1405556."}, {'pmid': '25102312', 'type': 'RESULT', 'citation': 'Saager L, Hesler BD, You J, Turan A, Mascha EJ, Sessler DI, Kurz A. Intraoperative transitions of anesthesia care and postoperative adverse outcomes. Anesthesiology. 2014 Oct;121(4):695-706. doi: 10.1097/ALN.0000000000000401.'}, {'pmid': '25794111', 'type': 'RESULT', 'citation': 'Hyder JA, Bohman JK, Kor DJ, Subramanian A, Bittner EA, Narr BJ, Cima RR, Montori VM. Anesthesia Care Transitions and Risk of Postoperative Complications. Anesth Analg. 2016 Jan;122(1):134-44. doi: 10.1213/ANE.0000000000000692.'}, {'pmid': '23360810', 'type': 'RESULT', 'citation': 'Salzwedel C, Bartz HJ, Kuhnelt I, Appel D, Haupt O, Maisch S, Schmidt GN. The effect of a checklist on the quality of post-anaesthesia patient handover: a randomized controlled trial. Int J Qual Health Care. 2013 Apr;25(2):176-81. doi: 10.1093/intqhc/mzt009. Epub 2013 Jan 29.'}, {'pmid': '29508531', 'type': 'RESULT', 'citation': "Lee SC, Atkinson ME, Minard CG, O'Brien A. Electronic tool helps anaesthesia trainee handovers. Clin Teach. 2019 Feb;16(1):58-63. doi: 10.1111/tct.12768. Epub 2018 Mar 6."}, {'pmid': '28437261', 'type': 'RESULT', 'citation': 'Jullia M, Tronet A, Fraumar F, Minville V, Fourcade O, Alacoque X, LeManach Y, Kurrek MM. Training in intraoperative handover and display of a checklist improve communication during transfer of care: An interventional cohort study of anaesthesia residents and nurse anaesthetists. Eur J Anaesthesiol. 2017 Jul;34(7):471-476. doi: 10.1097/EJA.0000000000000636.'}]}, 'descriptionModule': {'briefSummary': 'Implementation of a standardized handover checklist for intraoperative anesthesia care transition attenuates burnout among anesthesiologists and improves postoperative outcomes of patients undergoing major surgery , both of which benefit the quality of patient care and the development of anesthesiology.', 'detailedDescription': 'Many retrospective studies have demonstrated that among adults undergoing major surgery, complete handover of intraoperative anesthesia care compared with no handover was associated with a higher risk of adverse postoperative outcomes. Anesthesiologists keeping on working without handovers may experience symptoms of burnout which do not only pose a threat to the mental and physical health of the anesthesiologist, but also result in sub-optimal safety care of patients. Poor-quality handover without standardized processes can lead to diagnostic and therapeutic delays and precipitate adverse events. An improved system of anesthesia standardized handovers using a checklist would improve transfer of information and professional responsibility and therefore lead to the improvement of patient safety as well as burnout among anesthesiologists. Thus it is urgent to develop a standardized handover checklist for intraoperative anesthesia care to improve postoperative outcome of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients aged 18 years and older undergoing major surgeries requiring a hospital stay of at least 1 night are enrolled to use a checklist if they need handover of anesthesia care during surgery process.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 18 years and older undergoing major surgeries requiring a hospital stay of at least 1 night are enrolled in this study.\n\nExclusion Criteria:\n\n* Adult patients aged less than 18 years undergoing major surgeries and were not requiring a hospital stay of at least 1 night are excluded.'}, 'identificationModule': {'nctId': 'NCT03597932', 'briefTitle': 'Intraoperative Handover Checklist of Anesthesia Care Improves Outcomes Among Patients Undergoing Major Surgery', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'Intraoperative Handover Checklist of Anesthesia Care Improves Postoperative Outcomes Among Patients Undergoing Major Surgery: a Multicenter, Before-after Cohort Study', 'orgStudyIdInfo': {'id': 'xfang'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'baseline or control group', 'description': 'All participant anesthesiologists do intraoperative handover of anesthesia care according to a usual process or without checklist for 2-week to 1-month baseline data collection.'}, {'label': 'Checklist group', 'description': 'All participant anesthesiologists do intraoperative handover of anesthesia care by using a standardized handover checklist for another 2-week to 1-month data collection.', 'interventionNames': ['Device: standardized handover checklist']}], 'interventions': [{'name': 'standardized handover checklist', 'type': 'DEVICE', 'description': 'Following a review of relevant literatures and guidelines, a checklist consisting of the various key items necessary for giving continuing and safe intraoperative patient care was designed and validated by anesthesia residents and staff. Following 2-week to 1-month baseline data collection, each anesthesiologists and anesthesia residents in participating hospitals were asked to implement the safe-anesthesia checklist to improve practice over another 2-week to 1-month period. The checklist consists of an oral confirmation and closed-loop communication between the primary anesthesiologist and the replacement anesthesiologist. Evaluation of the effect of implementation of a standardized checklist during anesthesia care handover on patient safety during follow-up.', 'armGroupLabels': ['Checklist group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ye Hui', 'role': 'CONTACT', 'email': 'yehui@zju.edu.cn', 'phone': '+8615267048716'}, {'name': 'Cheng Baoli', 'role': 'CONTACT', 'email': 'chengbaoli1979@zju.edu.cn', 'phone': '+8613777479235'}], 'overallOfficials': [{'name': 'Fang Xiangming', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'first affilated hospital of zhejiang university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Share all the data after the first article was published on issue'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang Provincial Tongde Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor', 'investigatorFullName': 'xiangming fang', 'investigatorAffiliation': 'First Affiliated Hospital of Zhejiang University'}}}}