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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03597932
Other study ID # xfang
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date February 28, 2019

Study information

Verified date July 2018
Source First Affiliated Hospital of Zhejiang University
Contact Ye Hui
Phone +8615267048716
Email yehui@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3342
Est. completion date February 28, 2019
Est. primary completion date August 11, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
standardized handover checklist
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University Zhejiang Provincial Tongde Hospital

References & Publications (11)

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. — View 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. — View 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. — View 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 — View Citation

Lee SC, Atkinson ME, Minard CG, O'Brien A. Electronic tool helps anaesthesia trainee handovers. Clin Teach. 2018 Mar 6. doi: 10.1111/tct.12768. [Epub ahead of print] — View 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. — View 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. — View Citation

Salzwedel C, Bartz HJ, Kühnelt 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/mzt0 — View 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 An — View 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 R — View 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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of a composite of all-cause death, hospital readmission, or major postoperative complications 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 30 days
Secondary Incidence of 7 day-, 30 day-, 90 day- and inhospital mortality 7/30/90-day mortality, inhospital mortality 7/30/90 day
Secondary Incidence of major complications Postoperative major complications, defined by International Classification of Diseases, Tenth Revision (ICD-10) diagnostic codes 30 days
Secondary Incidence of ICU admission post surgery Incidence of postoperative intensive care unit (ICU) admission, ,within 30 days post surgery 30 days
Secondary The time of hospital length of stay (LOS) Hospital length of stay (LOS) up to 30 days
Secondary Incidence of emergency department (ED) visits Emergency department (ED) visits within 90 days of the index surgery 90 days
Secondary Any medical cost during hospital stay Any medical cost during hospital stay up to 90 days
Secondary Ventilation time within postoperative 30 days Ventilation time within postoperative 30 days Up to 30 days
Secondary Anaesthetic resuscitation time Anaesthetic resuscitation time after the surgery is completed Up to 24 hours
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