Clinical trial NCT03597932: Intraoperative Handover Checklist of Anesthesia Care Improves Outcomes Among Patients Undergoing Major Surgery
Official title: Intraoperative Handover Checklist of Anesthesia Care Improves Postoperative Outcomes Among Patients Undergoing Major Surgery: a Multicenter, Before-after Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Surgery--Complications
Burnout, Professional
Keywords: major surgery
ansethesia care
postoperative complication
handover checklist
anesthesiologist burnout
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial Tongde Hospital
First posted: 2018-07-24
Enrollment: 3342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 years and older undergoing major surgeries requiring a hospital stay of at least 1 night are enrolled in this study.

Exclusion Criteria:

* Adult patients aged less than 18 years undergoing major surgeries and were not requiring a hospital stay of at least 1 night are excluded.

Primary outcomes:
measure: Incidence of a composite of all-cause death, hospital readmission, or major postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of 7 day-, 30 day-, 90 day- and inhospital mortality
timeFrame: 7/30/90 day
measure: Incidence of major complications
timeFrame: 30 days
measure: Incidence of ICU admission post surgery
timeFrame: 30 days
measure: The time of hospital length of stay (LOS)
timeFrame: up to 30 days
measure: Incidence of emergency department (ED) visits
timeFrame: 90 days
measure: Any medical cost during hospital stay
timeFrame: up to 90 days
measure: Ventilation time within postoperative 30 days
timeFrame: Up to 30 days
measure: Anaesthetic resuscitation time
timeFrame: Up to 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: first affilated hospital of zhejiang university
name: Fang Xiangming
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.