Elderly PatientsNCT04377633
Anesthesia-handover Checklist and Perioperative Outcomes in Elderly
A study testing Oral handover and Checklist handover in people with Elderly Patients and Major Surgery, run by Peking University First Hospital at 1 site in China.
Trial summary
With the increasing number of surgical cases, intraoperative handover of anesthesia care is common and inevitable. Verbal handover from one anesthesiologist to another during surgery are being used in many hospitals. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly Patients, Major Surgery, Anesthesia; Adverse Effect
- What is being tested?
- Oral handover and Checklist handover
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,421 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2020to 23 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly patients (aged 65 years and over);
- Scheduled to undergo major non-cardiac surgery with an expected duration of at least 2 hours;
- Requirement of complete handover between anesthesiologists during surgery (initial anesthesiologist no longer returns).
Who cannot join
- Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;
- Inability to communicate before surgery (coma, profound dementia or language barrier);
- Craniocerebral injury or neurosurgery;
- Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (requiring dialysis), or expected survival of <24 hours.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Impact of an Anesthesia-handover Checklist on Perioperative Outcomes of Elderly Patients Undergoing Major Noncardiac Surgery: A Prospective Before-and-after Study
With the increasing number of surgical cases, intraoperative handover of anesthesia care is common and inevitable. Verbal handover from one anesthesiologist to another during surgery are being used in many hospitals. However, verbal handover is often an informal, unstructured process during which omissions and errors can occur. It is possible that an improved anesthesia handover may reduce the related adverse events. This study aims to test the hypothesis that use of a well-designed, structured handover-checklist to improve handover quality may decrease the occurrence of postoperative complications in elderly patients undergoing major noncardiac surgery.
Read the detailed description
It was estimated that more than 9 million patients undergo surgery with a complete anesthesia handover each year worldwide. Verbal handover from one anesthesiologist to another during surgery are being used in many hospitals; and there is no unified patient handover guideline at present.
It is well recognized that the transfer-of-care is a point of vulnerability where valuable patient information can be distorted and omitted. A previous study of the investigators showed that handover of anesthesia care was associated with a higher risk of delirium in elderly patients after major noncardiac surgery. The World Health Organization has included communication during patient care handovers among its top 5 patient safety initiatives.
It is possible that an improved anesthesia-handover protocol may reduce the related adverse events. Many efforts have performed to optimize handover processes. However, handover quality between anesthesiologists has rarely been investigated. The investigators hypothesize that a well-designed, structured handover-checklist will improve handover quality and reduce the occurrence of postoperative complications.
- Conditions
- Elderly Patients, Major Surgery, Anesthesia; Adverse Effect, Prevention, Postoperative Complications
- Being tested
- Oral handover, Checklist handover
- Keywords
- Elderly patients, Major surgery, Anesthesia handover, Handover checklist, Postoperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral handoverProcedure or surgery
Anesthesia handover during surgery will be performed as usual, i.e., oral exchange of pertinent clinical information.
Checklist handoverProcedure or surgery
Anesthesia handover during surgery will be performed according to a structured handover checklist.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | Sham comparator | Anesthesia handover during surgery will be performed as usual, i.e., a verbal exchange of pertinent clinical information. Receives: Procedure: Oral handover |
| Post-intervention | Experimental | Anesthesia handover during surgery will be performed according to a structured checklist. Receives: Procedure: Checklist handover |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite incidence of all complications within 30 days after surgery.
Include organ injury (delirium, acute kidney injury, and myocardial injury) within 3 days and other major complications (class II or higher on Clavien-Dindo classification) within 30 days after surgery.
Measured: Up to 30 days after surgery.
Secondary outcomes (6)
Intensive care unit admission after surgery.
Intensive care unit admission after surgery.
Measured: Up to 30 days after surgery.
Length of stay in the intensive care unit after surgery.
Length of stay in the intensive care unit after surgery.
Measured: Up to 30 days after surgery.
Incidence of organ injury (delirium, acute kidney injury, and acute myocardial injury) within 3 days after surgery.
Delirium is diagnosed with the Confusion Assessment Method. Acute kidney injury is diagnosed according to the KDIGO (Kidney Disease: Improving Global Outcomes) Criteria. Acute myocardial injury is diagnosed according to the serum cardiac tropinin I level.
Measured: Up to 3 days after surgery.
Incidence of major complications within 30 days after surgery.
Major complications are defined as newly occurred conditions that are harmful to patients' recovery and required medical therapy, i.e., class II or higher on the Clavien-Dindo classification.
Measured: Up to 30 days after surgery.
Length of hospital stay after surgery.
Length of hospital stay after surgery.
Measured: Up to 30 days after surgery.
All-cause mortality within 30 days after surgery.
All-cause mortality within 30 days after surgery.
Measured: Up to 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start16 Jul 2020
- Primary completion23 Nov 2023
- Study completion23 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Elderly PatientsStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377633
- Sponsor's protocol ID
- 2020-042
- Status last verified
- Nov 2024
- First submitted
- 4 May 2020
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choromanski D, Frederick J, McKelvey GM, Wang H. Intraoperative patient information handover between anesthesia providers. J Biomed Res. 2014 Sep;28(5):383-7. doi: 10.7555/JBR.28.20140001. Epub 2014 Jun 10.
PubMed 25332710Siddiqui N, Arzola C, Iqbal M, Sritharan K, Guerina L, Chung F, Friedman Z. Deficits in information transfer between anaesthesiologist and postanaesthesia care unit staff: an analysis of patient handover. Eur J Anaesthesiol. 2012 Sep;29(9):438-45. doi: 10.1097/EJA.0b013e3283543e43.
PubMed 22569028Singh H, Thomas EJ, Petersen LA, Studdert DM. Medical errors involving trainees: a study of closed malpractice claims from 5 insurers. Arch Intern Med. 2007 Oct 22;167(19):2030-6. doi: 10.1001/archinte.167.19.2030.
PubMed 17954795Arora V, Johnson J, Lovinger D, Humphrey HJ, Meltzer DO. Communication failures in patient sign-out and suggestions for improvement: a critical incident analysis. Qual Saf Health Care. 2005 Dec;14(6):401-7. doi: 10.1136/qshc.2005.015107.
PubMed 16326783Horwitz LI, Moin T, Krumholz HM, Wang L, Bradley EH. Consequences of inadequate sign-out for patient care. Arch Intern Med. 2008 Sep 8;168(16):1755-60. doi: 10.1001/archinte.168.16.1755.
PubMed 18779462Hudson 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.
PubMed 25440620Jones 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.
PubMed 29318277Liu GY, Su X, Meng ZT, Cui F, Li HL, Zhu SN, Wang DX. Handover of anesthesia care is associated with an increased risk of delirium in elderly after major noncardiac surgery: results of a secondary analysis. J Anesth. 2019 Apr;33(2):295-303. doi: 10.1007/s00540-019-02627-3. Epub 2019 Feb 28.
PubMed 30820749Hyder 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.
PubMed 25794111Kraman SS, Hamm G. Risk management: extreme honesty may be the best policy. Ann Intern Med. 1999 Dec 21;131(12):963-7. doi: 10.7326/0003-4819-131-12-199912210-00010.
PubMed 10610649Berkenstadt H, Haviv Y, Tuval A, Shemesh Y, Megrill A, Perry A, Rubin O, Ziv A. Improving handoff communications in critical care: utilizing simulation-based training toward process improvement in managing patient risk. Chest. 2008 Jul;134(1):158-62. doi: 10.1378/chest.08-0914.
PubMed 18628218Wayne JD, Tyagi R, Reinhardt G, Rooney D, Makoul G, Chopra S, Darosa DA. Simple standardized patient handoff system that increases accuracy and completeness. J Surg Educ. 2008 Nov-Dec;65(6):476-85. doi: 10.1016/j.jsurg.2008.06.011.
PubMed 19059181The Joint Commission releases Improving America's Hospitals: The Joint Commission's Annual Report on Quality and Safety, 2008. Jt Comm Perspect. 2009 Jan;29(1):3, 5. No abstract available.
PubMed 19368073Ferran NA, Metcalfe AJ, O'Doherty D. Standardised proformas improve patient handover: Audit of trauma handover practice. Patient Saf Surg. 2008 Sep 25;2:24. doi: 10.1186/1754-9493-2-24.
PubMed 18817559Riesenberg LA, Leitzsch J, Little BW. Systematic review of handoff mnemonics literature. Am J Med Qual. 2009 May-Jun;24(3):196-204. doi: 10.1177/1062860609332512. Epub 2009 Mar 5.
PubMed 19269930
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Anesthesia-handover Checklist on Perioperative Outcomes of Elderly Patients Undergoing Major Noncardiac Surgery: A Prospective Before-and-after Study
- ClinicalTrials.gov ID
- NCT04377633
- Acronym / sponsor ID
- 2020-042
- Conditions
- Elderly Patients, Major Surgery, Anesthesia; Adverse Effect, Prevention, Postoperative Complications
- Keywords
- Elderly patients, Major surgery, Anesthesia handover, Handover checklist, Postoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,421 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 Dec 2023 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the increasing number of surgical cases, intraoperative handover of anesthesia care is common and inevitable. Verbal handover from one anesthesiologist to another during surgery are being used in many hospitals. However, verbal handover is often an informal, unstructured process during which omissions and errors can occur. It is possible that an improved anesthesia handover may reduce the related adverse events. This study aims to test the hypothesis that use of a well-designed, structured handover-checklist to improve handover quality may decrease the occurrence of postoperative complications in elderly patients undergoing major noncardiac surgery.
Detailed description
It was estimated that more than 9 million patients undergo surgery with a complete anesthesia handover each year worldwide. Verbal handover from one anesthesiologist to another during surgery are being used in many hospitals; and there is no unified patient handover guideline at present.
It is well recognized that the transfer-of-care is a point of vulnerability where valuable patient information can be distorted and omitted. A previous study of the investigators showed that handover of anesthesia care was associated with a higher risk of delirium in elderly patients after major noncardiac surgery. The World Health Organization has included communication during patient care handovers among its top 5 patient safety initiatives.
It is possible that an improved anesthesia-handover protocol may reduce the related adverse events. Many efforts have performed to optimize handover processes. However, handover quality between anesthesiologists has rarely been investigated. The investigators hypothesize that a well-designed, structured handover-checklist will improve handover quality and reduce the occurrence of postoperative complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | Sham comparator | Procedure: Oral handoverAnesthesia handover during surgery will be performed as usual, i.e., a verbal exchange of pertinent clinical information. |
| Post-intervention | Experimental | Procedure: Checklist handoverAnesthesia handover during surgery will be performed according to a structured checklist. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Elderly patients (aged 65 years and over);
- Scheduled to undergo major non-cardiac surgery with an expected duration of at least 2 hours;
- Requirement of complete handover between anesthesiologists during surgery (initial anesthesiologist no longer returns).
Key exclusion criteria (4 listed)
- Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;
- Inability to communicate before surgery (coma, profound dementia or language barrier);
- Craniocerebral injury or neurosurgery;
- Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (requiring dialysis), or expected survival of <24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral handoverAnesthesia handover during surgery will be performed as usual, i.e., oral exchange of pertinent clinical information. | Procedure or surgery | Pre-intervention |
| Checklist handoverAnesthesia handover during surgery will be performed according to a structured handover checklist. | Procedure or surgery | Post-intervention |
Primary outcome
A composite incidence of all complications within 30 days after surgery.
Time frame: Up to 30 days after surgery.
Include organ injury (delirium, acute kidney injury, and myocardial injury) within 3 days and other major complications (class II or higher on Clavien-Dindo classification) within 30 days after surgery.
6 secondary outcomes
Intensive care unit admission after surgery.
Time frame: Up to 30 days after surgery.
Length of stay in the intensive care unit after surgery.
Time frame: Up to 30 days after surgery.
Incidence of organ injury (delirium, acute kidney injury, and acute myocardial injury) within 3 days after surgery.
Time frame: Up to 3 days after surgery.
Incidence of major complications within 30 days after surgery.
Time frame: Up to 30 days after surgery.
Length of hospital stay after surgery.
Time frame: Up to 30 days after surgery.
All-cause mortality within 30 days after surgery.
Time frame: Up to 30 days after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Background: PubMed 25332710Choromanski D, Frederick J, McKelvey GM, Wang H. Intraoperative patient information handover between anesthesia providers. J Biomed Res. 2014 Sep;28(5):383-7. doi: 10.7555/JBR.28.20140001. Epub 2014 Jun 10.
- Background: PubMed 22569028Siddiqui N, Arzola C, Iqbal M, Sritharan K, Guerina L, Chung F, Friedman Z. Deficits in information transfer between anaesthesiologist and postanaesthesia care unit staff: an analysis of patient handover. Eur J Anaesthesiol. 2012 Sep;29(9):438-45. doi: 10.1097/EJA.0b013e3283543e43.
- Background: PubMed 17954795Singh H, Thomas EJ, Petersen LA, Studdert DM. Medical errors involving trainees: a study of closed malpractice claims from 5 insurers. Arch Intern Med. 2007 Oct 22;167(19):2030-6. doi: 10.1001/archinte.167.19.2030.
- Background: PubMed 16326783Arora V, Johnson J, Lovinger D, Humphrey HJ, Meltzer DO. Communication failures in patient sign-out and suggestions for improvement: a critical incident analysis. Qual Saf Health Care. 2005 Dec;14(6):401-7. doi: 10.1136/qshc.2005.015107.
- Background: PubMed 18779462Horwitz LI, Moin T, Krumholz HM, Wang L, Bradley EH. Consequences of inadequate sign-out for patient care. Arch Intern Med. 2008 Sep 8;168(16):1755-60. doi: 10.1001/archinte.168.16.1755.
- Background: PubMed 25440620Hudson 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.
- Background: PubMed 29318277Jones 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.
- Background: PubMed 30820749Liu GY, Su X, Meng ZT, Cui F, Li HL, Zhu SN, Wang DX. Handover of anesthesia care is associated with an increased risk of delirium in elderly after major noncardiac surgery: results of a secondary analysis. J Anesth. 2019 Apr;33(2):295-303. doi: 10.1007/s00540-019-02627-3. Epub 2019 Feb 28.
- Background: PubMed 25794111Hyder 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.
- Background: PubMed 10610649Kraman SS, Hamm G. Risk management: extreme honesty may be the best policy. Ann Intern Med. 1999 Dec 21;131(12):963-7. doi: 10.7326/0003-4819-131-12-199912210-00010.
- Background: PubMed 18628218Berkenstadt H, Haviv Y, Tuval A, Shemesh Y, Megrill A, Perry A, Rubin O, Ziv A. Improving handoff communications in critical care: utilizing simulation-based training toward process improvement in managing patient risk. Chest. 2008 Jul;134(1):158-62. doi: 10.1378/chest.08-0914.
- Background: PubMed 19059181Wayne JD, Tyagi R, Reinhardt G, Rooney D, Makoul G, Chopra S, Darosa DA. Simple standardized patient handoff system that increases accuracy and completeness. J Surg Educ. 2008 Nov-Dec;65(6):476-85. doi: 10.1016/j.jsurg.2008.06.011.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Xin Wang, MD, PhD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral handover and Checklist handover in people with Elderly Patients and Major Surgery, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite incidence of all complications within 30 days after surgery. (time frame: Up to 30 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04377633, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.