Intraoperative Handover Checklist of Anesthesia Care Improves Outcomes Among Patients Undergoing Major Surgery

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03597932
Collaborator
Zhejiang Provincial Tongde Hospital (Other)
3,342
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: standardized handover checklist

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3342 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Intraoperative Handover Checklist of Anesthesia Care Improves Postoperative Outcomes Among Patients Undergoing Major Surgery: a Multicenter, Before-after Cohort Study
Anticipated Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Aug 11, 2018
Anticipated Study Completion Date :
Feb 28, 2019

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of a composite of all-cause death, hospital readmission, or major postoperative complications [30 days]

    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

Secondary Outcome Measures

  1. Incidence of 7 day-, 30 day-, 90 day- and inhospital mortality [7/30/90 day]

    7/30/90-day mortality, inhospital mortality

  2. Incidence of major complications [30 days]

    Postoperative major complications, defined by International Classification of Diseases, Tenth Revision (ICD-10) diagnostic codes

  3. Incidence of ICU admission post surgery [30 days]

    Incidence of postoperative intensive care unit (ICU) admission, ,within 30 days post surgery

  4. The time of hospital length of stay (LOS) [up to 30 days]

    Hospital length of stay (LOS)

  5. Incidence of emergency department (ED) visits [90 days]

    Emergency department (ED) visits within 90 days of the index surgery

  6. Any medical cost during hospital stay [up to 90 days]

    Any medical cost during hospital stay

  7. Ventilation time within postoperative 30 days [Up to 30 days]

    Ventilation time within postoperative 30 days

  8. Anaesthetic resuscitation time [Up to 24 hours]

    Anaesthetic resuscitation time after the surgery is completed

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • First Affiliated Hospital of Zhejiang University
  • Zhejiang Provincial Tongde Hospital

Investigators

  • Principal Investigator: Fang Xiangming, first affilated hospital of zhejiang university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
xiangming fang, Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor, First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier:
NCT03597932
Other Study ID Numbers:
  • xfang
First Posted:
Jul 24, 2018
Last Update Posted:
Jul 24, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by xiangming fang, Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor, First Affiliated Hospital of Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 24, 2018