NCT03597932

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,342

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

10 days

First QC Date

June 22, 2018

Last Update Submit

July 22, 2018

Conditions

Keywords

major surgeryansethesia carepostoperative complicationhandover checklistanesthesiologist burnout

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Incidence of 7 day-, 30 day-, 90 day- and inhospital mortality

    7/30/90 day

  • Incidence of major complications

    30 days

  • Incidence of ICU admission post surgery

    30 days

  • The time of hospital length of stay (LOS)

    up to 30 days

  • Incidence of emergency department (ED) visits

    90 days

  • +3 more secondary outcomes

Study Arms (2)

baseline or control group

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.

Checklist group

All participant anesthesiologists do intraoperative handover of anesthesia care by using a standardized handover checklist for another 2-week to 1-month data collection.

Device: standardized handover checklist

Interventions

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.

Checklist group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Burnout, ProfessionalPostoperative Complications

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fang Xiangming

    first affilated hospital of zhejiang university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 24, 2018

Study Start

August 1, 2018

Primary Completion

August 11, 2018

Study Completion

February 28, 2019

Last Updated

July 24, 2018

Record last verified: 2018-07