Impact of an Anesthesia Care Handover-Checklist on Adverse Perioperative Outcome (AnCHor)

Impact of an Anesthesia Care Handover-Checklist on Adverse Perioperative Outcome (AnCHor - Checklist) Pilot Trial

The aim of the study is to collect information on feasibility and effect size of a confirmatory, prospective study with the question: Does a standardized checklist during intraoperative handover of anaesthesia care reduce the rate of postoperative complications?

Study Overview

• Status: Unknown
• Conditions: Major Surgery
• Intervention / Treatment: Other: AnCHor-Checklist implementation

Detailed Description

During clinical routine, intraoperative handover of anaesthesia care occurs frequently. This handover between two anaesthesiologists requires the transmission of all relevant information concerning the patient and the ongoing procedure. Studies regarding the influence of such handovers on patient outcome are inconclusive and mostly of retrospective nature. Some studies report a negative effect of handovers on patients mortality and outcome, however studies exist reporting no effect. A positive effect of intraoperative handovers as a result of a "second man" effect ist also possible. To increase handover quality, the German Society of Anaesthesiology and Intensive Care Medicine (DGAI) recommends the application of the situation, background, assessment and recommendation (SBAR) concept. Information are arranged in those four groups with the goal of structuring the handover and incorporating all relevant information. Studies show increased accuracy of transferred information and improved comprehensibility when using the SBAR concept. Whether an intraoperative handover according to the SBAR concept reduces the rate of postoperative complications is not yet investigated. Due to lack of information regarding feasibility and effect size, the investigators plan a prospective pilot study to answer these questions. Initially, patients undergoing major surgery are recruited where handover is performed without a standardized handover. After the implementation of a checklist using the SBAR concept, this checklist will be used during intraoperative handover in recruited patients where a handover occurs. The primary endpoint is a combined endpoint consisting of all-cause mortality, readmission to any hospital, or major postoperative complications. Additionally, implementation rate and efficacy of the checklist will be evaluated.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Recruiting
      • Department of Anaesthesiology, University Hospital Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective major non cardiac surgery, admitted to University Hospital Heidelberg

Description

Inclusion Criteria:

• Age ≥ 18 years
• Major surgeries with a duration of at least 2 h (requirement of postoperative admission to hospital for at least 1 night)
• American Society of Anesthesiologists (ASA) Classification 3-4
• Informed consent

Exclusion Criteria:

• Patients incapable of consent
• Previous surgery within the same surgical subgroup within the last 6 months
• Pregnancy, breastfeeding
• Patients participating in another interventional trial within the last 3 months with possible interference to the outcome of this study
• Persons with any kind of dependency on the investigator or employed by the investigator

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-checklist implementation group; Patients undergoing major elective surgery where intraoperative handover occurs. This handover is performed according to current hospital standard without a standardized checklist.
Post-checklist implementation group; Patients undergoing major elective surgery where intraoperative handover occurs. This handover is performed after implementation of the AnCHor-CHecklist, a standardized checklist based on the SBAR concept.	Other: AnCHor-Checklist implementation; a standardized checklist using the SBAR concept according to the recommendations of the DGAI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of mortality, hospital readmission and major postoperative complications	Number of patients that die and/or are readmitted to any hospital and/or experience any of the following: prolonged postoperative ventilation >48 hours, major disruption of surgical wound, bleeding, pneumonia, atrial fibrillation, moderate or severe acute kidney injury, new onset of hemodialysis, cardiac arrest, myocardial infarction, sepsis, stroke, pulmonary embolism, deep venous thrombosis, shock, unplanned return to operating room	within 30 days of index surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation of checklist	Rate of correctly filed checklists	on day of index surgery
Determination of recruitment rate	Rate of recruited patients in all recruitable patients	within 30 days of index surgery
Prolonged postoperative Ventilation >48 hours	Number of patients with prolonged postoperative ventilation defined as ≥ 48h need of invasive mechanical ventilation via endotracheal tube or need for tracheostomy due to prolonged weaning	within 48 hours after index surgery
Major disruption of surgical wound	Number of patients with major disruption of surgical wound defined as the need for re-operation (wound dehiscence, burst abdomen)	within 30 days of index surgery
Bleeding	Number of patients with bleeding complications defined as major bleeding with transfusion requirement and/ or the need for re-operation (hematothorax, relaparotomy, and removal of hematoma)	within the initial surgical procedure and within 30 days after index surgery
Insufficiency of anastomoses	Number of patients with insufficiency of anastomoses defined by International Study Group of Rectal Cancer (ISREC)-definition	within 30 days of index surgery
Intra-abdominal abcess	Number of patients with intra-abdominal abscess defined by imaging	within 30 days of index surgery
Pneumonia	Number of patients with pneumonia defined as occurence of pneumonia verified by X-ray	within 30 days of index surgery
Atrial fibrillation	Number of patients with atrial fibrillation defined as new onset of atrial fibrillation without any known episode prior to index surgery	within 30 days of index surgery
Occurrence of moderate or severe acute kidney injury	Number of patients with moderate acute kidney injury (AKI) defined as Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 (≥ 2-fold increase in serum-creatinine from baseline and/or urine output < 0.5 ml/kg/h for ≥ 12 h) or severe AKI is defined as KDIGO stage 3 (≥ 3-fold serum creatinine increase from baseline and/or urine output ≤ 0.3 ml/kg/h for ≥ 24 h)	within 30 days after index surgery
New onset of hemodialysis	Number of patients with new onset of need for renal replacement therapy	within 30 days after index surgery
Cardiac arrest	Number of patients with cardiac arrest defined as the need for cardiopulmonary resuscitation	within 30 days of index surgery
Myocardial infarction	Number of patients with myocardial infarction defined by by ST elevation in the ECG and/or troponin elevation in patients with acute chest pain	during index surgery and within 30 days after index surgery
Sepsis	Number of patients with sepsis defined according to Sepsis3 guidelines	within 30 days of index surgery
Stroke	Number of patients with stroke defined by verification in a CT scan	within 30 days of index surgery
Pulmonary embolism and deep venous thromboembolism	Number of patients with pulmonary embolism and deep venous thromboembolism defined by verification in a CT scan	within 30 days of index surgery
Shock	Number of patients with shock defined based on the corresponding International Statistical Classification of Diseases and Related Health Problems (ICD-10) codes (R57.1, R57.8, R57.9)	during the initial surgical procedure and within 30 days after index surgery
unplanned return to operating room	Number of patients with unplanned return to operating room within time frame	within 30 days of index surgery
Need for intervention	Number of patients with interventions defined as endoscopy, Insertion of drains or stents	within 30 days of index surgery
Hospital length of stay	Documented in patient charts	within 30 days of index surgery
ICU admission	Number of patients with ICU admission	within 30 days of index surgery
ICU length of stay	Documented in patient charts	within 30 days of index surgery
total morbidity	defined by Comprehensive Complication Index (CCI)	within 30 days of index surgery
All-cause mortality	Number of patients died within 30 days of index surgery	within 30 days of index surgery
Readmission to any hospital	Number of patients with any readmission to an acute care hospital	within 30 days of index surgery

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Terekhov MA, Ehrenfeld JM, Dutton RP, Guillamondegui OD, Martin BJ, Wanderer JP. Intraoperative Care Transitions Are Not Associated with Postoperative Adverse Outcomes. Anesthesiology. 2016 Oct;125(4):690-9. doi: 10.1097/ALN.0000000000001246.
• McCrory MC, Aboumatar H, Custer JW, Yang CP, Hunt EA. "ABC-SBAR" training improves simulated critical patient hand-off by pediatric interns. Pediatr Emerg Care. 2012 Jun;28(6):538-43. doi: 10.1097/PEC.0b013e3182587f6e.
• Randmaa M, Martensson G, Leo Swenne C, Engstrom M. SBAR improves communication and safety climate and decreases incident reports due to communication errors in an anaesthetic clinic: a prospective intervention study. BMJ Open. 2014 Jan 21;4(1):e004268. doi: 10.1136/bmjopen-2013-004268.
• Agarwala AV, Firth PG, Albrecht MA, Warren L, Musch G. An electronic checklist improves transfer and retention of critical information at intraoperative handoff of care. Anesth Analg. 2015 Jan;120(1):96-104. doi: 10.1213/ANE.0000000000000506.
• Marshall S, Harrison J, Flanagan B. The teaching of a structured tool improves the clarity and content of interprofessional clinical communication. Qual Saf Health Care. 2009 Apr;18(2):137-40. doi: 10.1136/qshc.2007.025247.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 29, 2020
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): November 1, 2021

Study Registration Dates

• First Submitted: September 26, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (ACTUAL): October 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 1, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: anaesthesia; handover; checklist; perioperative complications
• Other Study ID Numbers: ANCHOR (Other Identifier: AIDS Malignancy Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No