Effect of Intraoperative Handovers of Anesthesia Care on Mortality, Readmission, or Postoperative Complications Among Adults: The HandiCAP Randomized Clinical Trial

Melanie Meersch; Raphael Weiss; Mira Küllmar; Lars Bergmann; Astrid Thompson; Leonore Griep; Desiree Kusmierz; Annika Buchholz; Alexander Wolf; Hartmuth Nowak; Tim Rahmel; Michael Adamzik; Jan Gerrit Haaker; Carina Goettker; Matthias Gruendel; Andre Hemping-Bovenkerk; Ulrich Goebel; Julius Braumann; Irawan Wisudanto; Manuel Wenk; Darius Flores-Bergmann; Andreas Böhmer; Sebastian Cleophas; Andreas Hohn; Anne Houben; Richard K Ellerkmann; Jan Larmann; Julia Sander; Markus A Weigand; Nicolas Eick; Sebastian Ziemann; Eike Bormann; Joachim Gerß; Daniel I Sessler; Carola Wempe; Christina Massoth; Alexander Zarbock

doi:10.1001/jama.2022.9451

. 2022 Jun 4;327(24):2403–2412. doi: 10.1001/jama.2022.9451

Effect of Intraoperative Handovers of Anesthesia Care on Mortality, Readmission, or Postoperative Complications Among Adults

The HandiCAP Randomized Clinical Trial

Melanie Meersch ^1,^✉, Raphael Weiss ¹, Mira Küllmar ¹, Lars Bergmann ², Astrid Thompson ², Leonore Griep ², Desiree Kusmierz ², Annika Buchholz ², Alexander Wolf ², Hartmuth Nowak ², Tim Rahmel ², Michael Adamzik ², Jan Gerrit Haaker ², Carina Goettker ³, Matthias Gruendel ³, Andre Hemping-Bovenkerk ³, Ulrich Goebel ³, Julius Braumann ⁴, Irawan Wisudanto ⁴, Manuel Wenk ⁴, Darius Flores-Bergmann ⁵, Andreas Böhmer ⁵, Sebastian Cleophas ^6,⁷, Andreas Hohn ^6,⁷, Anne Houben ⁸, Richard K Ellerkmann ^8,⁹, Jan Larmann ¹⁰, Julia Sander ¹⁰, Markus A Weigand ¹⁰, Nicolas Eick ¹¹, Sebastian Ziemann ¹², Eike Bormann ¹³, Joachim Gerß ¹³, Daniel I Sessler ¹⁴, Carola Wempe ¹, Christina Massoth ¹, Alexander Zarbock ¹

¹Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany

²Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Knappschaftskrankenhaus Bochum, Bochum, Germany

³Department of Anesthesiology, Department of Anesthesiology and Critical Care, Franziskus Hospital Münster, Münster, Germany

⁴Department of Anesthesiology, Intensive Care and Pain Medicine, Florence-Nightingale-Hospital, Düsseldorf, Germany

⁵Department of Anesthesiology and Operative Intensive Care Medicine, Kliniken Köln, Köln, Germany, Witten/Herdecke University, Faculty of Health, School of Medicine

⁶Department of Anesthesiology and Intensive Care Medicine, Kliniken Maria Hilf, Mönchengladbach, Germany

⁷Faculty of Medicine and University Hospital of Cologne, Department of Anesthesiology and Intensive Care Medicine, University of Cologne, Cologne, Germany

⁸Department of Anesthesiology, Intensive Care and Pain Medicine, Klinikum Dortmund, Dortmund, Germany

⁹Department of Anesthesiology and Intensive Care Medicine, University Hospital Bonn, Bonn, Germany

¹⁰Department of Anesthesiology, University Hospital Heidelberg, Heidelberg, Germany

¹¹Department of Anesthesiology, Intensive Care and Pain Medicine, Dortmund-Hörde, Germany

¹²Department of Anesthesiology, Medical Faculty, RWTH Aachen University, Aachen, Germany

¹³Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany

¹⁴Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio

^✉

Corresponding Author: Melanie Meersch, MD, Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Albert-Schweitzer-Campus 1, Bldg A1, 48149 Münster, Germany (meersch@uni-muenster.de).

Accepted for Publication: May 20, 2022.

Published Online: June 4, 2022. doi:10.1001/jama.2022.9451

Author Contributions: Drs Meersch and Zarbock had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Massoth and Zarbock contributed equally.

Concept and design: Meersch, Thompson, Rahmel, Gerß, Wempe, Zarbock.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Meersch, Weiss, Küllmar, Kusmierz, Buchholz, Wisudanto, Bormann, Gerß, Massoth, Zarbock.

Critical revision of the manuscript for important intellectual content: Meersch, Weiss, Bergmann, Thompson, Griep, Wolf, Nowak, Rahmel, Adamzik, Haaker, Goettker, Gruendel, Hemping-Bovenkerk, Goebel, Braumann, Wenk, Flores-Bergmann, Böhmer, Cleophas, Hohn, Houben, Ellerkmann, Larmann, Sander, Weigand, Eick, Ziemann, Gerß, Sessler, Wempe, Massoth.

Statistical analysis: Meersch, Bormann, Gerß, Zarbock.

Obtained funding: Meersch, Bergmann.

Administrative, technical, or material support: Weiss, Küllmar, Bergmann, Griep, Kusmierz, Buchholz, Nowak, Rahmel, Adamzik, Haaker, Gruendel, Goebel, Wisudanto, Böhmer, Ellerkmann, Ziemann, Wempe, Massoth.

Supervision: Thompson, Adamzik, Wisudanto, Wenk, Ellerkmann, Weigand, Gerß, Zarbock.

Conflict of Interest Disclosures: Dr Meersch reported receiving fees from bioMérieux, FMC, and Baxter outside the submitted work. Dr Zarbock reported receiving grants from Baxter, Fresenius, BioMérieux, the German Research Foundation, the German Israel Foundation, and Astellas outside the submitted work and personal fees from Novartis, Bayer, Guard Therapeutics, AM Pharma, bioMérieux, Fresenius, Baxter, and Paion outside the submitted work; and serving as a section editor for Anesthesia & Analgesia and for Anästhesist. No other disclosures were reported.

Funding/Support: The trial was funded by Else-Kröner-Fresenius Stiftung German Research Foundation (grants 2018_A96, KFO342-1, ZA428/18-1, ZA428/21-1, and ME5413/1-1).

Role of the Funder/Sponsor: The Else-Kröner-Fresenius Stiftung and the German Research Foundation had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data and Safety Monitoring Board: Department of Anesthesiology, University Hospital Düsseldorf, Germany: Peter Kienbaum, MD; Department of Anesthesiology, Intensive Care and Pain Medicine, Schwarzwald-Baar Klinikum, University of Witten Herdecke, Germany: Sebastian Russo, MD; and Institute for Mathematics and Techniques, University of Applied Sciences Koblenz, Germany, Markus Neuhäuser, MD.

Data Sharing Statement: See Supplement 4.

Additional Contributions: We would like to thank all the study nurses of all participating centers for data entry and the staff in the participating ICUs.

^✉

Corresponding author.

PMCID: PMC9167439 PMID: 35665794

Key Points

Question

Among adults undergoing extended surgical procedures, what is the effect of an intraoperative handover of anesthesia care on clinical outcomes?

Findings

In this randomized clinical trial that included 1772 patients, the composite primary outcome of mortality, readmission, or serious postoperative complications within 30 days did not differ significantly among participants randomized to receive handover of anesthesia care vs no handover of care (30% vs 33%, respectively).

Meaning

Among adults undergoing extended surgical procedures, there was no significant difference between handover of anesthesia care compared with no handover of care in the risk of postoperative morbidity and mortality.

Abstract

Importance

Intraoperative handovers of anesthesia care are common. Handovers might improve care by reducing physician fatigue, but there is also an inherent risk of losing critical information. Large observational analyses report associations between handover of anesthesia care and adverse events, including higher mortality.

Objective

To determine the effect of handovers of anesthesia care on postoperative morbidity and mortality.

Design, Setting, and Participants

This was a parallel-group, randomized clinical trial conducted in 12 German centers with patients enrolled between June 2019 and June 2021 (final follow-up, July 31, 2021). Eligible participants had an American Society of Anesthesiologists physical status 3 or 4 and were scheduled for major inpatient surgery expected to last at least 2 hours.

Interventions

A total of 1817 participants were randomized to receive either a complete handover to receive anesthesia care by another clinician (n = 908) or no handover of anesthesia care (n = 909). None of the participating institutions used a standardized handover protocol.

Main Outcomes and Measures

The primary outcome was a 30-day composite of all-cause mortality, hospital readmission, or serious postoperative complications. There were 19 secondary outcomes, including the components of the primary composite, along with intensive care unit and hospital lengths of stay.

Results

Among 1817 randomized patients, 1772 (98%; mean age, 66 [SD, 12] years; 997 men [56%]; and 1717 [97%] with an American Society of Anesthesiologists physical status of 3) completed the trial. The median total duration of anesthesia was 267 minutes (IQR, 206-351 minutes), and the median time from start of anesthesia to first handover was 144 minutes in the handover group (IQR, 105-213 minutes). The composite primary outcome occurred in 268 of 891 patients (30%) in the handover group and in 284 of 881 (33%) in the no handover group (absolute risk difference [RD], −2.5%; 95% CI, −6.8% to 1.9%; odds ratio [OR], 0.89; 95% CI, 0.72 to 1.10; P = .27). Nineteen of 889 patients (2.1%) in the handover group and 30 of 873 (3.4%) in the no handover group experienced all-cause 30-day mortality (absolute RD, −1.3%; 95% CI, −2.8% to 0.2%; OR, 0.61; 95% CI, 0.34 to 1.10; P = .11); 115 of 888 (13%) vs 136 of 872 (16%) were readmitted to the hospital (absolute RD, −2.7%; 95% CI, −5.9% to 0.6%; OR, 0.80; 95% CI, 0.61 to 1.05; P = .12); and 195 of 890 (22%) vs 189 of 874 (22%) experienced serious postoperative complications (absolute RD, 0.3%; 95% CI, −3.6% to 4.1%; odds ratio, 1.02; 95% CI, 0.81 to 1.28; P = .91). None of the 19 prespecified secondary end points differed significantly.

Conclusions and Relevance

Among adults undergoing extended surgical procedures, there was no significant difference between the patients randomized to receive handover of anesthesia care from one clinician to another, compared with the no handover group, in the composite primary outcome of mortality, readmission, or serious postoperative complications within 30 days.

Trial Registration

ClinicalTrials.gov Identifier: NCT04016454

This randomized trial tested whether intraoperative handovers of care from one clinician to another compared with no handover affected a postoperative composite of all-cause mortality, hospital readmission, and serious complications.

Introduction

In 2012, an estimated 310 million surgical procedures with anesthesia were performed, with greater frequency since then.^1,2 Nine million patients had surgery that included a complete anesthesia handover, usually secondary to professional or personal commitments and duty-hour restrictions but also due to physician illness or fatigue.^1,3,4 The potential consequences of care transitions include loss of critical information, which may result in suboptimal care and patient harm.^3,5,6 Information transfer in a noisy and distracting environment while continuing patient care entails considerable risk of communication failure.^7,8 Conversely, continued care by a fatigued clinician also imposes risk.⁹

Retrospective analyses in large cohorts of patients who had cardiac and major noncardiac procedures reported discrepant findings.^3,10 Although some failed to identify associations between intraoperative transition of anesthesia care and complications, others reported that handovers were associated with an increased risk of short-term mortality and serious postoperative complications including surgical revision, hemorrhage, organ dysfunction, and thromboembolic complications.^{3,5,11,12,13,14,15}

Observational analyses of handovers cannot fully control for confounding. Therefore, a multicenter randomized trial testing the primary hypothesis that intraoperative handovers of anesthesia have an effect on a composite of all-cause mortality, hospital readmission, and serious postoperative complications was conducted.

Methods

Study Design and Ethics

A detailed description of the HandiCAP trial procedures was published¹⁶ (see also the study protocol in Supplement 1 and the statistical analysis plan in Supplement 2). Approval was obtained from the Ethics Committee of the Chamber of Physicians Westfalen-Lippe and the Westphalian-Wilhelms University Muenster (2018-470-f-S) and from the corresponding boards at each site. Patient enrollment began after starting the trial registration process. Due to several requests, official registration was delayed until after 3 patients were enrolled. These patients were included in the full analysis set.

Written informed consent was obtained from participating patients before surgery. An independent data and safety monitoring board provided trial oversight and reviewed blinded safety data. Study design and manuscript preparation followed Consolidated Standards of Reporting Trials (CONSORT) recommendations.

Patient Recruitment

Adults aged 18 years or older who were designated American Society of Anesthesiologists (ASA)¹⁷ physical status 3 or 4 and were scheduled for major inpatient surgery with an anticipated duration of 2 or more hours were enrolled. Major surgeries were targeted within the broad range of general, neurological, vascular, orthopedic, gynecologic, thoracic, urological, trauma, plastic, and cardiac surgery and were identified by experienced anesthesiologists and/or surgeons. Patients were excluded if they had previous surgery by the same specialty within 6 months, were pregnant or breastfeeding, or participated in another interventional trial within the last 3 months.

Randomization

Patients were randomly assigned to 1 of the 2 treatment groups in a 1:1 ratio in permuted blocks of 4 and 6 and stratification by site and anesthesiologist training level (≤2 years, >2-5 years, or >5 years) through a central web-based system. Supervisors who allocated handovers were unblinded, whereas patients and outcome assessors were not informed of the treatment assignments. Because handovers of anesthesia care or lack thereof are routine, treating anesthesiologists were unaware whether a particular handover was per clinical routine or due to trial participation. Neither supervisors nor treating anesthesiologists were informed of the trial hypothesis.

Procedures

Anesthesia care was provided by anesthesia interns or residents (≥5 years’ training is required to become a specialist) or by specialists (without responsibility of supervising residents). Patients assigned to the no handover strategy were treated by the same anesthesiologist from the point of anesthesia induction to the end of the surgical procedure. Patients allocated to the handover group were to have at least 1 complete transition of care from one anesthesiologist to another during surgery (the exact time point of the handover was not prespecified).

The change of the treating anesthesiologist was organized such that the experience level of incoming clinicians was similar to that of outgoing clinicians. After the handover was completed, the outgoing anesthesiologist was no longer available for further consultation. Handovers were restricted to the in-room anesthesiologist. In cases in which an intern or resident was involved, the supervising attending physicians remained unchanged. Short breaks up to 45 minutes provided by the supervising attending were not considered handovers. None of the participating centers used a structured handover protocol. Handovers were therefore conducted according to institutional standards, which include conveying information about important organ systems and special patient-specific conditions.

Depending on their experience, treating interns or residents were supervised by an attending physician. Supervisors were generally present during anesthetic induction but then only intermittently because they were responsible for 3 to 4 operating rooms. Experienced residents provided care independently, but could always call an attending.

Outcomes

The primary end point was a composite of all-cause mortality, readmission to any hospital, or serious postoperative complication within 30 days after the index surgery. Serious complications included postoperative ventilation for 48 hours or more, major disruption of a surgical wound requiring surgical revision, major bleeding with transfusion, pneumonia, new-onset of atrial fibrillation, moderate and severe acute kidney injury (Kidney Disease: Improving Global Outcomes stage 2 or 3),¹⁸ new onset of kidney replacement therapy, cardiac arrest, myocardial infarction, sepsis per Third International Consensus¹⁹ definition, stroke, pulmonary embolism and deep venous thromboembolism, shock (cardiogenic, hypovolemic, distributive, or obstructive shock), and unplanned reoperation within 30 days. Secondary end points were the components of the primary composite and intensive care unit (ICU) and hospital lengths of stay.

Sample Size Calculation

The sample size estimate was performed with the PASS-software version 14 based on a meta-analysis of 4 published trials using a similar primary end point. Primary composite end point rates were assumed to be 20.8% in the handover and 15.6% in the no handover group (difference, 5.2%).^3,5,11,12 A total of 864 patients per group provided 80% power at a 2-sided α of 5%. Assuming a 5% dropout rate, the resulting total sample size was 1814 patients (eMethods in Supplement 3).

Statistical Analysis

Statistical analyses were planned prior to unblinding the study statistician and reviewing the data.²⁰ A full description is presented in Supplement 2. Standardized differences between study groups were calculated using SAS macro stddiff.²¹

The primary analysis included all randomized and evaluable patients (full analysis set). Patients were analyzed according to their randomized assignment, disregarding protocol violations. Missing data were not imputed. In sensitivity analyses, patients with major protocol deviations were excluded. The primary analysis was performed using the 2-sided Cochran-Mantel-Haenszel χ² test, stratified by trial site and anesthesiologist experience. Categorical secondary outcomes were analyzed with Fisher exact tests, and in additional sensitivity analyses with the Cochran-Mantel-Haenszel test. Censored lengths of hospital and ICU stays were analyzed with Cox regression (specified post hoc) after confirming the proportional hazards assumption using Grambsch-Therneau tests. Primary and secondary outcomes were considered significant at a 2-sided P ≤ .05. Secondary outcomes were not corrected for multiplicity, and the findings for secondary outcomes should be interpreted as exploratory.

Results are presented as odds ratios (ORs) and absolute risk differences (RDs) with 95% CIs for categorical variables and Hodges-Lehmann estimator of location shift for continuous variables.²² In stratified analyses, both ORs and absolute RDs were first calculated within each stratum and then pooled over all strata to determine a common OR and absolute RD.

Multivariable logistic regression for the primary end point was conducted using site as a random effect and adjusting for relevant baseline characteristics was conducted (type of surgery and revised cardiac risk index). Additionally, the number of handovers and experience level of the initial anesthesiologist were included.

Safety end points were the components of the primary composite within 30 days and were evaluated on an as-treated basis.

The following post hoc analyses were performed. The primary end point was compared between randomized groups using logistic regression, adjusting for stratification factors (site as a random effect and experience level as a fixed effect). Number of anesthesia procedures with supervision and anesthesia complications were compared between exposure groups using the Fisher exact test. In subgroups by duration of surgery, primary and secondary outcomes were compared between randomized groups using the Cochran-Mantel-Haenszel test. Occurrence of secondary end points within 7 days and in-hospital mortality were compared between randomized groups using the Cochran-Mantel-Haenszel test. For patients with 1 handover, the primary outcome was compared between different experience levels of the first and second anesthesiologist using the Fisher exact test. Association between the primary and secondary end points and the number of handovers was presented descriptively. Death within 24 hours and in-hospital mortality were analyzed as post hoc outcomes. The results of post hoc analyses were considered significant at a 2-sided P ≤ .05 without correction for multiplicity and should be interpreted as hypothesis generating.

Statistical analyses were performed using SAS version 9.4 (SAS Institute Inc).

Results

Patients

From June 2019 to June 2021, 6626 patients were screened for eligibility, of whom 1817 were randomized (final date of follow-up, July 31, 2021). Forty-five patients were excluded from the primary analysis because they were lost to follow-up for the primary end point. Ultimately, there were 1772 patients in the full analysis set, with 891 patients (50.3%) randomly assigned to the handover group, anesthesia car from another clinician, and 881 (49.7%) to the no handover group (Figure 1).

Figure 1. — ^aPatients lost to follow-up could not be reached, so no data were available.

^bPatients with protocol deviations (deviation from inclusion and exclusion criteria, deviation from the randomized study group, cancellation of the surgical procedure, and premature termination of study participation) were excluded from the per-protocol analysis.

Baseline characteristics and surgical details of patients in the primary analysis did not differ meaningfully between the 2 groups (Table 1 and eTables 1 and 2 in Supplement 3). The mean age of those in the primary analysis was 66 (SD, 12) years, 997 (56%) were men, 1440 (82%) had social health insurance, the median Charlson Comorbidity Index was 5 (IQR, 4-7), and 1717 (97%) were designated ASA grade 3.

Table 1. Baseline Characteristics of Patients in the Primary Analysis of the HandiCAP Randomized Clinical Trial.

	No. (%) of patients
	Handover (n = 891)	No handover (n = 881)
Patient demographics
Age, mean (SD), y	65.9 (11.9)	66.4 (12.0)
Weight, mean (SD), kg	82.7 (19.7)	81.6 (19.0)
Height, mean (SD), m	1.7 (0.1)	1.7 (0.1)
BMI, median (IQR)	27.1 (23.7-31.1)	26.8 (23.7-30.4)
Sex
Men	499 (56.1)	498 (56.8)
Women	391 (43.9)	379 (43.2)
Insurance^a
Private	151 (17.0)	175 (20.0)
Social	738 (83.0)	702 (80.1)
Comorbidities
ASA score^b
3 (severe general illness)	862 (97.2)	855 (97.5)
4 (life-threatening general illness)	25 (2.8)	22 (2.5)
Charlson Comorbidity Index, median (IQR)^c	5 (4-7)	5 (4-7)
Surgical morbidity risk assessment, median (IQR), %
Modified NSQIP^d	13.2 (8.7-20.0)	12.6 (8.3-19.4)
SURPAS^e	28.9 (21.5-36.7)	28.5 (21.4-35.7)
Hypertension	639 (71.8)	656 (75.0)
Cancer	464 (52.1)	430 (49.1)
Peripheral vascular disease	232 (26.1)	222 (25.4)
Chronic pulmonary disease	218 (24.5)	216 (24.7)
Coronary artery disease	207 (23.3)	217 (24.8)
Diabetes	186 (20.9)	180 (20.6)
Congestive heart failure	135 (15.2)	120 (13.7)
Cerebrovascular disease	131 (14.7)	126 (14.4)
Myocardial infarction	115 (12.9)	114 (13.1)
Moderate or severe CKD	106 (11.9)	88 (10.1)
Anesthesiologist characteristics
Level of training of initial anesthesiologist, resident-y
1	175 (19.7)	189 (21.6)
2-3	215 (24.2)	220 (25.2)
4-5	243 (27.3)	208 (23.8)
>5 y	59 (6.6)	87 (10.0)
Specialist	110 (12.4)	104 (11.9)
Attending physician	88 (9.9)	66 (7.6)
Surgery
Duration of surgery, min^f
Mean (SD)	219 (121)	196 (109)
Median (IQR)	189 (136-275)	168 (120-250)
Admission category
Elective	866 (97.3)	855 (97.6)
Emergency	24 (2.7)	21 (2.4)

Open in a new tab

Abbreviations: ASA, American Society of Anesthesiology; BMI, body mass index, calculated as weight in kilograms divided by height in meters squared; CKD, chronic kidney disease; NSQIP, National Surgical Quality Improvement Program; SURPAS, Surgical Risk Preoperative Assessment.

^{^a}

Patients with private insurance were cared for by department chairs or their representatives, at least for anesthetic induction. Other patients were cared for by any available anesthesiologists.

^{^b}

American Society of Anesthesiology classifications are defined as follows (grades 1, 2, and 5 patients were not eligible for inclusion): 3, a patient with severe systemic disease that limits physical activity; and 4, a patient with severe systemic disease that is a constant threat to life.

^{^c}

The Charlson Comorbidity Index is a list of 17 comorbidities identified by the International Classification of Diseases, each of which is assigned a weight from 1 to 6 (0 indicates healthy patients [no comorbidities identified]; higher scores indicate the presence of additional comorbidities).

^{^d}

NSQIP is a surgical prediction tool using 24 variables to predict multiple adverse events, here we show a modified NSQIP (missing variables were ascites within 30 days prior to surgery, steroid use for chronic condition, smoking status, dyspnea).

^{^e}

SURPAS is a surgical prediction tool of 8 adverse outcomes using 8 predictor variables.

^{^f}

Duration of surgery is the time from skin incision to skin suture.

Overall, 1721 patients (97%) had elective surgery (Table 1). The most common procedures were general surgery (26%), neurosurgery (25%), vascular surgery (19%), and orthopedic procedures (17%) (eTable 2 in Supplement 3). The median duration of surgery was 180 minutes (IQR, 128-258 minutes). Most patients had balanced anesthesia or combined general and regional anesthesia. The median duration of anesthesia induction was 28 minutes (IQR, 19-41 minutes), and the total anesthesia duration was 267 minutes (IQR, 206-351 minutes; Table 2).

Table 2. Anesthesia Details.

	No. (%) of patients		Absolute difference (handover vs no handover), %	Standardized difference^a
	Handover (n = 891)	No handover (n = 881)	Absolute difference (handover vs no handover), %	Standardized difference^a
No. of complete handovers, median (IQR)^b	1 (1 to 1)	0	1 (1 to 1)
0	116 (13.0)	795 (91.0)	−77.9 (−80.8 to −75.0)	2.50
1	635 (71.4)	69 (7.9)	63.5 (60.0 to 66.9)
2	127 (14.3)	8 (0.9)	13.4 (11.0 to 15.7)
3	9 (1.0)	1 (0.1)	0.9 (0.2 to 1.6)
4	3 (0.3)	1 (0.1)	0.2 (0.2 to 0.7)
Start of anesthesia to first handover, median (IQR), min^c	140 (102 to 196)	272 (163 to 484)	−125 (−171 to −89)	−0.82
Time on duty before index operation, mean (SD), min	126 (120)	108 (113)	7 (3 to 13)	0.15
Start time of anesthesia for index surgery^b
7-9 am	460 (51.7)	496 (56.8)	−5.1 (−9.7 to 0.4)	0.17
9-11 am	213 (23.9)	204 (23.3)	0.6 (−3.4 to 4.6)
11 am-1 pm	155 (17.4)	129 (14.8)	0.3 (−0.8 to 6.1)
1-3 pm	55 (6.2)	40 (4.6)	1.6 (−0.5 to 3.7)
3-5 pm	5 (0.6)	4 (0.5)	0.1 (−0.6 to 0.8)
5-9 pm	2 (0.2)	1 (0.1)	0.1 (−0.3 to 0.5)
Supervision by attending physician^d	592 (66.5)	646 (74.1)	−7.6 (−11.8 to 3.3)	−0.17
Type of anesthesia
Balanced	637 (54.9)	673 (58.5)	−3.7 (−7.7 to 0.4)	0.21
Total intravenous	246 (21.2)	186 (16.2)	5.0 (1.8 to 8.2)
Epidural	218 (18.8)	222 (19.3)	−0.6 (−3.8 to 2.6)
Peripheral regional	41 (3.5)	41 (3.6)	0.1 (−1.5 to 1.6)
Spinal	14 (1.2)	23 (2.0)	−0.8 (−1.8 to 0.2)
Change of anesthetic procedure	5 (0.4)	6 (0.5)	−0.0 (−0.5 to 0.5)
Duration of anesthesia induction, min^e
Mean (SD)	32 (26)	33 (23)	0 (−2 to 1)	−0.01
Median (IQR)	27 (19 to 41)	29 (19 to 41)		−0.01
Total duration of anesthesia, min^f
Mean (SD)	304 (127)	283 (121)	20 (10 to 30)	0.17
Median (IQR)	278 (216 to 369)	259 (195 to 342)		0.17
Complications during anesthesia induction	273 (30.7)	288 (33.0)	−2.6 (−7.6 to 2.4)	−0.05
Bradycardia	132 (37.8)	135 (36.2)	1.6 (−5.4 to 8.7)	0.27
Severe hypotension	91 (26.1)	93 (24.9)	1.1 (−5.2 to 7.5)
Hypertension	70 (20.1)	80 (21.5)	−1.4 (−7.3 to 4.5)
Multiple punctures	25 (7.2)	35 (9.4)	−2.2 (−6.2 to 1.8)
Tachycardia	9 (2.6)	10 (2.7)	−0.1 (−2.4 to 2.2)
Catheter malposition	4 (1.2)	3 (0.8)	0.3 (−1.1 to 1.8)
Broncholaryngospasm	3 (0.9)	0	0.9 (−0.1 to 1.8)
Aspiration	1 (0.3)	0	0.3 (−0.3 to 0.9)
Tooth demolition	1 (0.3)	0	0.3 (−0.3 to 0.9)
Unsuccessful intubation	1 (0.3)	6 (1.6)	−1.3 (−2.7 to 0.1)

Open in a new tab

^{^a}

Standardized differences were calculated according to Yang and Dalton.²¹ The standardized difference shows the clinical relevance of the difference between groups (0.2, small; 0.5, medium; ≥0.8 large).

^{^b}

One missing value in the handover and 7 in the no handover group because patients were randomized but surgical procedure was not performed.

^{^c}

Only patients with handovers included.

^{^d}

Depending on their experience, treating interns or residents were supervised by an attending physician. Supervisors were generally present during anesthetic induction, but then only intermittently.

^{^e}

Anesthesia induction is defined as start of any anesthesia induction process (eg, hypnotic administration or epidural catheter insertion) and patients being ready for surgery.

^{^f}

Total duration of anesthesia is defined as start of any anesthesia induction process up to the end of anesthesia (eg, extubation).

Details of Anesthesia Care

A total of 774 patients (87.0%) in the handover group had a transition of anesthesia care, with 635 (71.4%) having 1 transition, and 127 (14.3%) having 2 transitions (Table 2). Of the patients in no handover group, 795 (91.0%) were continuously cared for by a single anesthesiologist whereas 69 patients (7.9%) had 1 handover (Table 2). Consequently, 116 patients (13.0%) assigned to a handover and 79 (9.0%) assigned to the no handover group did not receive the designated management (Table 2; eTable 3 in Supplement 3).

Most handovers were performed in the morning (Table 2). The anesthesiologists’ time on duty before surgical procedures was similar between groups: the mean time was 126 (SD, 120) minutes in the handover group and was 108 (SD, 113) minutes in the no handover group. The median time from start of anesthesia to first handover was 140 minutes (IQR, 102-196 minutes) in the handover group and 272 minutes (IQR, 163-484 minutes) in the no handover group. Most anesthetic inductions were supervised by attendings in both groups but less often among patients assigned to the handover group (67% vs 74%; P < .001, Table 2). Educational level of the initial anesthesiologist was similar in both groups (Table 2 and eTable 4 in Supplement 3). The most common complications during anesthetic induction were bradycardia, severe hypotension, and hypertension (Table 2 and eTable 3 in Supplement 3).

Primary Outcome

The primary composite end point did not differ significantly between the 2 groups, with 268 events (30.1%) among patients in the handover group and 284 (32.5%) among patients in the no handover group (absolute RD, −2.5%; 95% CI, −6.8% to 1.9%; OR, 0.89; 95% CI, 0.72 to 1.10; P = .27; Table 3 and eTable 5 in Supplement 3).

Table 3. Clinical Outcomes.

	Handover (n = 891)^a	No handover (n = 881)^a	Absolute risk difference (95% CI), %^b		P value
Primary outcome
Composite end point consisting of all-cause mortality, readmission to a hospital, and serious postoperative complications within 30 d, No. (%)	268 (30.1)	284 (32.5)	−2.5 (−6.8 to 1.9)	0.89 (0.72 to 1.10)	.27^d
Secondary outcomes
Breakdown of the composite end point, No./total (%)
All-cause mortality within 30 d	19/889 (2.1)	30/873 (3.4)	−1.3 (−2.8 to 0.2)	0.61 (0.34 to 1.10)	.11^e
Readmission within 30 d	115/888 (13.0)	136/872 (15.6)	−2.7 (−5.9 to 0.6)	0.80 (0.61 to 1.05)	.12^e
Serious postoperative complications within 30 d	195/890 (21.9)	189/874 (21.6)	0.3 (−3.6 to 4.1)	1.02 (0.81 to 1.28)	.91^e
Serious postoperative complications in detail, No. (%)
Prolonged ventilation ≥48 h	27 (3.0)	20 (2.3)	0.8 (−0.8 to 2.3)	1.34 (0.74 to 2.40)	.38^e
Major disruption surgical wound	62 (7.0)	57 (6.5)	0.4 (−1.9 to 2.8)	1.07 (0.74 to 1.56)	.78^e
Bleeding	54 (6.1)	60 (6.9)	−0.8 (−3.1 to 1.5)	0.88 (0.60 to 1.28)	.50^e
Pneumonia	34 (3.8)	37 (4.2)	−0.4 (−2.3 to 1.4)	0.90 (0.56 to 1.44)	.72^e
New onset atrial fibrillation	10 (1.1)	9 (1.0)	0.1 (−0.9 to 1.1)	1.09 (0.44 to 2.70)	>.99^e
Moderate and severe AKI	30 (3.4)	22 (2.5)	0.9 (− 0.7 to 2.4)	1.35 (0.77 to 2.36)	.33^e
New onset KRT	11 (1.2)	8 (0.9)	0.3 (−0.6 to 1.3)	1.35 (0.54 to 3.38)	.65^e
Cardiac arrest	9 (1.0)	17 (2.0)	−0.9 (−2.1 to 0.2)	0.51 (0.23 to 1.16)	.12^e
Myocardial infarction	8 (0.9)	4 (0.5)	0.4 (−0.3 to 1.2)	1.97 (0.59 to 6.58)	.39^e
Sepsis	30 (3.4)	42 (4.8)	−1.4 (−3.3 to 0.4)	0.69 (0.43 to 1.11)	.15^e
Stroke	4 (0.5)	8 (0.9)	−0.5 (−1.2 to 0.3)	0.49 (0.15 to 1.63)	.26^e
Pulmonary embolism or deep venous thrombosis	10 (1.1)	15 (1.7)	−0.6 (−1.7 to 0.5)	0.65 (0.29 to 1.46)	.32^e
Shock	34 (3.8)	33 (3.8)	0.0 (−1.7 to 1.8)	1.01 (0.62 to 1.65)	>.99^e
Unplanned return to operating room	116 (13.0)	101 (11.6)	1.5 (−1.6 to 4.5)	1.15 (0.86 to 1.52)	.35^e
Length of stay, median (IQR), d
Hospital	8.0 (6.0-15.0)	8.0 (6.0- 14.0)	0 (0 to 1)	HR, 0.95 (0.86 to 1.04)^f^,^h	.25^g
ICU	1.0 (1.0-3.0)	1.0 (1.0-3.0)	0 (0 to 0)	HR, 0.96 (0.87 to 1.05)^f^,^h	.36^g

Open in a new tab

Abbreviations: AKI, acute kidney injury; ICU, intensive care unit; HR, hazard ratio; KRT, kidney replacement therapy; OR, odds ratio.

^{^a}

Total numbers are included when they differ from those in the overall study group.

^{^b}

Absolute risk difference <0 indicates an effect in favor of handover compared to no handover.

^{^c}

OR less than 1 indicates an effect in favor of handover compared with no handover.

^{^d}

Cochran-Mantel-Haenszel χ² test.

^{^e}

Fisher exact test.

^{^f}

HR less than 1 indicates an effect in favor of handover compared with no handover.

^{^g}

Wald χ² test.

^{^h}

Censored at the day of death during hospital stay.

Secondary Outcomes

Mortality, readmissions, and serious postoperative complications did not significantly differ by group (Table 3). The most frequent complications were unplanned return to the operating room (12.3%), major disruption of surgical wound (6.8%), and bleeding (6.5%). There were 463 patients (52.0%) in the handover group and 419 (48.0%) in the no handover group who required ICU admission (P = .10). The durations of ICU stays were not significantly different with a median of 1 day (IQR, 1-3 days) in the handover group vs 1 day (IQR, 1- 3 days) in the no handover group (P = .36). Hospital length of stay also did not differ significantly (median, 8 days; IQR, 6-15 days in the handover group and 8 days; IQR, 6-14 days in the no handover group; P = .25, Table 3).

Additional Analyses

Type of surgery, revised cardiac risk index, number of handovers, and training level were not significantly associated with serious postoperative complications (Figure 2 and eTable 6 in Supplement 3). Results of the safety analysis are reported in eTable 7 in Supplement 3.

Figure 2. — In the model, site was included as random effect and type of surgery, revised cardiac risk index, number of handovers, and training level as fixed effects. Type of surgery was not significant (P = .26) and was not included in the figure in detail (eTable 6 in Supplement 3).

Post Hoc Analysis and Outcomes

Results of the primary analysis were confirmed in a mixed model, adjusting for stratification factors with site as a random effect and training level as a fixed effect (OR, 0.89; 95% CI, 0.73 to 1.09; P = .27). There was no significant heterogeneity across trial sites (eFigure in Supplement 3). The overall incidence of the primary composite end point was 30.2% (275 of 911) among patients without handovers, 33.5% (236 of 704) among those with 1 handover, and 25.2% (34 of 135) among those with 2 handovers (eTable 8A and B in Supplement 3). The incidence of the composite end point did not differ significantly depending on the educational level of the relieving anesthesiologist (eTable 9A and B in Supplement 3).

A sensitivity analysis restricted to complications occurring within the first 7 days demonstrated that, with the exception of moderate to severe acute kidney injury being higher in the handover group (27 patients [3.0%] in the handover group vs 14 [1.6%] in the no handover group; absolute RD, 1.5%; 95% CI, 0.1%-to 2.9%; OR, 2.03; 95% CI, 1.00 to 4.29; P = .04), serious postoperative complications did not differ significantly by group (eTable 10 in Supplement 3). In analyses by duration of surgery, the primary outcome was significantly more common in patients in the fourth duration quartile (>180 min) than those in the first duration quartile (≤128 min). However, the odds for the composite outcomes for the handover vs no handover groups were not significantly different within each quartile (eTable 11 in Supplement 3). Neither the number of deaths within 24 hours (1 patient [0.1%] in the handover group vs 0 in the no handover group) nor the in-hospital mortality (22 patients [2.5%] in the handover group vs 31 [3.6%] in the no handover group) differed significantly (OR, 0.70; 95% CI, 0.38-1.27; P = .25).

Discussion

Among adults undergoing prolonged surgery, there was no significant difference between handovers of anesthesia care compared with no handovers of anesthesia care on the composite primary outcome of mortality, readmission, or serious postoperative complications within 30 days.

To our knowledge, there have not been prior randomized clinical trials of intraoperative care transitions but many cohort analyses have reported associations between care transitions and harms including mortality, prolonged ICU and hospital stays, bleeding and infectious complications, and longer ventilation times.^3,5,11,12,14 Others, though, have reported no significant association between handovers and harm.^10,15 Apart from being limited by their retrospective designs, most included relatively healthy patients although the risk of inadequate information transfer is presumably greatest in sicker patients.^3,5,10,12 Nearly all patients in this trial were designated ASA grade 3, indicating that patients were at risk for complications. Nevertheless, handovers of anesthesia care did not significantly increase the incidence of the primary composite outcome of mortality, readmission, or serious postoperative complications within 30 days.

Clear communication reduces error during personnel transitions.^23,24 For example, in a study of 134 pediatric intensive care patients, 94% of the handovers included more than 1 communication error.²⁵ Techniques to improve the quality of communication including tools to ensure that transmitted information is received and understood are common outside health care such as in air traffic control and in the military. Standardized communication tools have been developed for anesthesia, but are rarely used.^26,27,28 None of the trial sites used structured handover protocols. But given that unstructured handovers did not worsen complications, it seems unlikely that results would differ substantively had a formal transition process been used.

Observational analyses are susceptible to unmeasured confounding, and this may be a particular concern for analyses of care transitions because many potentially important factors are not recorded in electronic records, including the trajectory of a particular case and whether replacement clinicians were selected for special relevant skills or even personal circumstances such as a disagreement between the anesthesiologist and surgeon. Randomization minimizes the likelihood of confounding and selection bias. This trial thus enhances available understanding of the putative relationship between intraoperative care transitions and serious postoperative complications and readmission, and indicates that if there is such a relationship, its magnitude is small.

The sample-size estimate was based on a 21% incidence of serious postoperative complications.^3,5,11,12 The observed incidence was higher (31%) and similar to that reported in the largest retrospective report (32%).³ The relatively high incidence may reflect restricting the enrollment to patients classified as ASA grades 3 and 4. Most patients in the handover group had 1 or 2 anesthesia care transitions (86%) whereas only 1% had 3 or 4. This trial was not powered to analyze results by the number of handovers, but 1 or 2 handovers did not significantly increase the risk of complications.

Limitations

This study has several limitations. First, 11% of the patients in each group did not receive the designated management strategy for various reasons including lack of personnel and unplanned changes in surgical duration. However, per protocol analyses confirmed the primary findings. Second, patients who had nighttime or weekend surgery were not included because insufficient staffing precluded adherence with the randomization. Thus, this study could not address whether handovers are harmful during off-hours when patients often have greater illness severity and clinicians are stressed and fatigued.

Third, it was not possible to account for structure and conduct of handovers as well as for the experience of surgeons, anesthesiologists, and surgical nurses. Consequently, the effect of the experience of the surgeons and other involved personnel remains unknown. Fourth, some types of surgery, notably cardiac surgery, were underrepresented. Because cardiac surgery differs substantially from noncardiac surgery, the results may not generalize to that population.

Fifth, it was not possible to fully mask those who participated in this study because personnel assignments, including handovers, needed to be made by an unmasked coordinator. The potential for bias thus remains because the assigner could influence the timing of handovers, and which clinicians replaced the initial team. Nevertheless, patients, clinicians, and investigators were not informed of the treatment assignments. Treating anesthesiologists were thus masked to which patients were included in the trial.

Sixth, intraoperative complications were not recorded. Therefore, it cannot be assessed whether handovers provoked intraoperative events. However, there was no difference in short-term outcomes. Seventh, nearly all patients were categorized ASA grade 3. Lack of harm from anesthesia care transitions presumably applied to healthier patients but may not apply to patients with greater severity of illness who may be categorized as ASA grade 4. Future trials are warranted to evaluate whether the results are generalizable to different patients, various health care systems, and regional delivery models.

Conclusions

Supplement 1.

Trial Protocol

Click here for additional data file.^{(4.8MB, pdf)}

Supplement 2.

Statistical Analysis Plan

Click here for additional data file.^{(341.3KB, pdf)}

Supplement 3.

eMethods. Sample size calculation

eFigure. Primary endpoint by site

eTable 1. Further baseline characteristics

eTable 2. Operative details

eTable 3. Anesthesia details (per protocol)

eTable 4. Experience of anesthesiologists

eTable 5. Clinical outcomes (per protocol)

eTable 6. Multivariable regression analysis

eTable 7. Safety analysis

eTable 8a. Outcomes per number of handovers (full analysis set)

eTable 8b. Outcomes per number of handovers (per protocol)

eTable 9a. Primary outcome by educational level between first and second anesthesiologist

eTable 9b. Outcomes by level of training

eTable 10. Outcomes within 7 days

Table 11. Outcomes by surgical duration time

eReferences

Additional Participating Investigators

Data and Safety Monitoring Board

List of Surgeries

Click here for additional data file.^{(891KB, pdf)}

Supplement 4.

Data Sharing Statement

Click here for additional data file.^{(11KB, pdf)}

References

1.Weiser TG, Haynes AB, Molina G, et al. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015;385(suppl 2):S11. doi: 10.1016/S0140-6736(15)60806-6 [DOI] [PubMed] [Google Scholar]
2.Meara JG, Leather AJ, Hagander L, et al. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Lancet. 2015;386(9993):569-624. doi: 10.1016/S0140-6736(15)60160-X [DOI] [PubMed] [Google Scholar]
3.Jones PM, Cherry RA, Allen BN, et al. Association between handover of anesthesia care and adverse postoperative outcomes among patients undergoing major surgery. JAMA. 2018;319(2):143-153. doi: 10.1001/jama.2017.20040 [DOI] [PMC free article] [PubMed] [Google Scholar]
4.Inadequate hand-off communication. Sentinel Event Alert. 2017;(58):1-6. [PubMed] [Google Scholar]
5.Saager L, Hesler BD, You J, et al. Intraoperative transitions of anesthesia care and postoperative adverse outcomes. Anesthesiology. 2014;121(4):695-706. doi: 10.1097/ALN.0000000000000401 [DOI] [PubMed] [Google Scholar]
6.Sun LY, Jones PM, Wijeysundera DN, Mamas MA, Bader Eddeen A, O’Connor J. Association between handover of anesthesiology care and 1-year mortality among adults undergoing cardiac surgery. JAMA Netw Open. 2022;5(2):e2148161. doi: 10.1001/jamanetworkopen.2021.48161 [DOI] [PMC free article] [PubMed] [Google Scholar]
7.Keller S, Tschan F, Beldi G, Kurmann A, Candinas D, Semmer NK. Noise peaks influence communication in the operating room: an observational study. Ergonomics. 2016;59(12):1541-1552. doi: 10.1080/00140139.2016.1159736 [DOI] [PubMed] [Google Scholar]
8.Douglas RN, Stephens LS, Posner KL, et al. Communication failures contributing to patient injury in anaesthesia malpractice claims. Br J Anaesth. 2021;127(3):470-478. doi: 10.1016/j.bja.2021.05.030 [DOI] [PMC free article] [PubMed] [Google Scholar]
9.Boet S, Djokhdem H, Leir SA, Théberge I, Mansour F, Etherington N. Association of intraoperative anaesthesia handovers with patient morbidity and mortality: a systematic review and meta-analysis. Br J Anaesth. 2020;125(4):605-613. doi: 10.1016/j.bja.2020.05.062 [DOI] [PMC free article] [PubMed] [Google Scholar]
10.Terekhov MA, Ehrenfeld JM, Dutton RP, Guillamondegui OD, Martin BJ, Wanderer JP. Intraoperative care transitions are not associated with postoperative adverse outcomes. Anesthesiology. 2016;125(4):690-699. doi: 10.1097/ALN.0000000000001246 [DOI] [PubMed] [Google Scholar]
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 Vase Anesth. 2015;29(1):11-16. doi: 10.1053/j.jvca.2014.05.018 [DOI] [PubMed] [Google Scholar]
12.Heeder JA, Bohman JK, Kore DJ, et al. Anesthesia care transitions and risk of postoperative complications. Ansty Analg. 2016;122(1):134-144. doi: 10.1213/ANE.0000000000000692 [DOI] [PubMed] [Google Scholar]
13.Liu GY, Sun X, Meng ZT, et al. Handover of anesthesia care is associated with an increased risk of delirium in elderly after major noncardiac surgery: results of a secondary analysis. J Ansett. 2019;33(2):295-303. doi: 10.1007/s00540-019-02627-3 [DOI] [PMC free article] [PubMed] [Google Scholar]
14.Hannan EL, Samadashvili Z, Sundt TM III, et al. Association of anesthesiologist handovers with short-term outcomes for patients undergoing cardiac surgery. Anesth Analg. 2020;131(6):1883-1889. doi: 10.1213/ANE.0000000000005221 [DOI] [PubMed] [Google Scholar]
15.O’Reilly-Shah VN, Melanson VG, Sullivan CL, Jabaley CS, Lynde GC. Lack of association between intraoperative handoff of care and postoperative complications: a retrospective observational study. BMC Anesthesiol. 2019;19(1):182. doi: 10.1186/s12871-019-0858-8 [DOI] [PMC free article] [PubMed] [Google Scholar]
16.Massoth C, Saadat-Gilani K, Meersch M, Handi CAPI; HandiCAP Investigators . Impact of handover of anesthesia care on adverse postoperative outcomes—the HandiCAP trial. Article in German. Anaesthesist. 2021;70(4):320-323. doi: 10.1007/s00101-021-00940-9 [DOI] [PubMed] [Google Scholar]
17.Thackray NM, Gibbs NM. American Society of Anesthesiologists P5: “with or without” definition? Anesthesiology. 2011;114(2):467-468. doi: 10.1097/ALN.0b013e3182065c88 [DOI] [PubMed] [Google Scholar]
18.Acute Kidney Injury Work Group . KDIGO Clinical Practice Guideline for Acute Kidney Injury 2012. Kidney Int Suppl. 2012;2:1-138. doi: 10.1038/kisup.2012.6 [DOI] [Google Scholar]
19.Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315(8):801-810. doi: 10.1001/jama.2016.0287 [DOI] [PMC free article] [PubMed] [Google Scholar]
20.International conference on harmonisation; guidance on statistical principles for clinical trials; availability—FDA. Notice. Fed Regist. 1998;63(179):49583-49598. [PubMed] [Google Scholar]
21.Yang D, Dalton JE. A unified approach to measuring the effect size between two groups using SAS. Paper presented at: SAS Global Forum 2012; April 22-25, 2012; Orlando, Florida. Accessed December 2021. https://support.sas.com/resources/papers/proceedings12/335-2012.pdf
22.Hodges JL Jr, Lehmann EL. Hodges-Lehmann estimators. In: Johnson NL, Kotz S, Read C, eds. Encyclopedia of Statistical Sciences; vol 3. Wiley. 1983:642-645. [Google Scholar]
23.Olejniczak MJ, Apostolidou I, Prielipp RC. Two minutes to improve cardiac surgery outcomes. Anesth Analg. 2017;125(2):380-382. doi: 10.1213/ANE.0000000000002265 [DOI] [PubMed] [Google Scholar]
24.Bagian JP, Paull DE. Handovers during anesthesia care: patient safety risk or opportunity for improvement? JAMA. 2018;319(2):125-127. doi: 10.1001/jama.2017.20602 [DOI] [PubMed] [Google Scholar]
25.Mistry KP, Landrigtan CP, Goldman DA, Bates DW. Communication error during post-operative patient handoff in the pediatric intensive care unit. Crit Care Med. 2005;33(12):A12. doi: 10.1097/00003246-200512002-00047 [DOI] [Google Scholar]
26.Haig KM, Sutton S, Whittington J. SBAR: a shared mental model for improving communication between clinicians. Jt Comm J Qual Patient Saf. 2006;32(3):167-175. doi: 10.1016/S1553-7250(06)32022-3 [DOI] [PubMed] [Google Scholar]
27.Starmer AJ, O’Toole JK, Rosenbluth G, et al. ; I-PASS Study Education Executive Committee . Development, implementation, and dissemination of the I-PASS handoff curriculum: a multisite educational intervention to improve patient handoffs. Acad Med. 2014;89(6):876-884. doi: 10.1097/ACM.0000000000000264 [DOI] [PubMed] [Google Scholar]
28.Starmer AJ, Spector ND, Srivastava R, et al. ; I-PASS Study Group . Changes in medical errors after implementation of a handoff program. N Engl J Med. 2014;371(19):1803-1812. doi: 10.1056/NEJMsa1405556 [DOI] [PubMed] [Google Scholar]

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplement 1.

Trial Protocol

Click here for additional data file.^{(4.8MB, pdf)}

Supplement 2.

Statistical Analysis Plan

Click here for additional data file.^{(341.3KB, pdf)}

Supplement 3.

eMethods. Sample size calculation

eFigure. Primary endpoint by site

eTable 1. Further baseline characteristics

eTable 2. Operative details

eTable 3. Anesthesia details (per protocol)

eTable 4. Experience of anesthesiologists

eTable 5. Clinical outcomes (per protocol)

eTable 6. Multivariable regression analysis

eTable 7. Safety analysis

eTable 8a. Outcomes per number of handovers (full analysis set)

eTable 8b. Outcomes per number of handovers (per protocol)

eTable 9a. Primary outcome by educational level between first and second anesthesiologist

eTable 9b. Outcomes by level of training

eTable 10. Outcomes within 7 days

Table 11. Outcomes by surgical duration time

eReferences

Additional Participating Investigators

Data and Safety Monitoring Board

List of Surgeries

Click here for additional data file.^{(891KB, pdf)}

Supplement 4.

Data Sharing Statement

Click here for additional data file.^{(11KB, pdf)}

[joi220060r1] 1.Weiser TG, Haynes AB, Molina G, et al. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015;385(suppl 2):S11. doi: 10.1016/S0140-6736(15)60806-6 [DOI] [PubMed] [Google Scholar]

[joi220060r2] 2.Meara JG, Leather AJ, Hagander L, et al. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Lancet. 2015;386(9993):569-624. doi: 10.1016/S0140-6736(15)60160-X [DOI] [PubMed] [Google Scholar]

[joi220060r3] 3.Jones PM, Cherry RA, Allen BN, et al. Association between handover of anesthesia care and adverse postoperative outcomes among patients undergoing major surgery. JAMA. 2018;319(2):143-153. doi: 10.1001/jama.2017.20040 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi220060r4] 4.Inadequate hand-off communication. Sentinel Event Alert. 2017;(58):1-6. [PubMed] [Google Scholar]

[joi220060r5] 5.Saager L, Hesler BD, You J, et al. Intraoperative transitions of anesthesia care and postoperative adverse outcomes. Anesthesiology. 2014;121(4):695-706. doi: 10.1097/ALN.0000000000000401 [DOI] [PubMed] [Google Scholar]

[joi220060r6] 6.Sun LY, Jones PM, Wijeysundera DN, Mamas MA, Bader Eddeen A, O’Connor J. Association between handover of anesthesiology care and 1-year mortality among adults undergoing cardiac surgery. JAMA Netw Open. 2022;5(2):e2148161. doi: 10.1001/jamanetworkopen.2021.48161 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi220060r7] 7.Keller S, Tschan F, Beldi G, Kurmann A, Candinas D, Semmer NK. Noise peaks influence communication in the operating room: an observational study. Ergonomics. 2016;59(12):1541-1552. doi: 10.1080/00140139.2016.1159736 [DOI] [PubMed] [Google Scholar]

[joi220060r8] 8.Douglas RN, Stephens LS, Posner KL, et al. Communication failures contributing to patient injury in anaesthesia malpractice claims. Br J Anaesth. 2021;127(3):470-478. doi: 10.1016/j.bja.2021.05.030 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi220060r9] 9.Boet S, Djokhdem H, Leir SA, Théberge I, Mansour F, Etherington N. Association of intraoperative anaesthesia handovers with patient morbidity and mortality: a systematic review and meta-analysis. Br J Anaesth. 2020;125(4):605-613. doi: 10.1016/j.bja.2020.05.062 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi220060r10] 10.Terekhov MA, Ehrenfeld JM, Dutton RP, Guillamondegui OD, Martin BJ, Wanderer JP. Intraoperative care transitions are not associated with postoperative adverse outcomes. Anesthesiology. 2016;125(4):690-699. doi: 10.1097/ALN.0000000000001246 [DOI] [PubMed] [Google Scholar]

[joi220060r11] 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 Vase Anesth. 2015;29(1):11-16. doi: 10.1053/j.jvca.2014.05.018 [DOI] [PubMed] [Google Scholar]

[joi220060r12] 12.Heeder JA, Bohman JK, Kore DJ, et al. Anesthesia care transitions and risk of postoperative complications. Ansty Analg. 2016;122(1):134-144. doi: 10.1213/ANE.0000000000000692 [DOI] [PubMed] [Google Scholar]

[joi220060r13] 13.Liu GY, Sun X, Meng ZT, et al. Handover of anesthesia care is associated with an increased risk of delirium in elderly after major noncardiac surgery: results of a secondary analysis. J Ansett. 2019;33(2):295-303. doi: 10.1007/s00540-019-02627-3 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi220060r14] 14.Hannan EL, Samadashvili Z, Sundt TM III, et al. Association of anesthesiologist handovers with short-term outcomes for patients undergoing cardiac surgery. Anesth Analg. 2020;131(6):1883-1889. doi: 10.1213/ANE.0000000000005221 [DOI] [PubMed] [Google Scholar]

[joi220060r15] 15.O’Reilly-Shah VN, Melanson VG, Sullivan CL, Jabaley CS, Lynde GC. Lack of association between intraoperative handoff of care and postoperative complications: a retrospective observational study. BMC Anesthesiol. 2019;19(1):182. doi: 10.1186/s12871-019-0858-8 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi220060r16] 16.Massoth C, Saadat-Gilani K, Meersch M, Handi CAPI; HandiCAP Investigators . Impact of handover of anesthesia care on adverse postoperative outcomes—the HandiCAP trial. Article in German. Anaesthesist. 2021;70(4):320-323. doi: 10.1007/s00101-021-00940-9 [DOI] [PubMed] [Google Scholar]

[joi220060r17] 17.Thackray NM, Gibbs NM. American Society of Anesthesiologists P5: “with or without” definition? Anesthesiology. 2011;114(2):467-468. doi: 10.1097/ALN.0b013e3182065c88 [DOI] [PubMed] [Google Scholar]

[joi220060r18] 18.Acute Kidney Injury Work Group . KDIGO Clinical Practice Guideline for Acute Kidney Injury 2012. Kidney Int Suppl. 2012;2:1-138. doi: 10.1038/kisup.2012.6 [DOI] [Google Scholar]

[joi220060r19] 19.Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315(8):801-810. doi: 10.1001/jama.2016.0287 [DOI] [PMC free article] [PubMed] [Google Scholar]

[joi220060r20] 20.International conference on harmonisation; guidance on statistical principles for clinical trials; availability—FDA. Notice. Fed Regist. 1998;63(179):49583-49598. [PubMed] [Google Scholar]

[joi220060r21] 21.Yang D, Dalton JE. A unified approach to measuring the effect size between two groups using SAS. Paper presented at: SAS Global Forum 2012; April 22-25, 2012; Orlando, Florida. Accessed December 2021. https://support.sas.com/resources/papers/proceedings12/335-2012.pdf

[joi220060r22] 22.Hodges JL Jr, Lehmann EL. Hodges-Lehmann estimators. In: Johnson NL, Kotz S, Read C, eds. Encyclopedia of Statistical Sciences; vol 3. Wiley. 1983:642-645. [Google Scholar]

[joi220060r23] 23.Olejniczak MJ, Apostolidou I, Prielipp RC. Two minutes to improve cardiac surgery outcomes. Anesth Analg. 2017;125(2):380-382. doi: 10.1213/ANE.0000000000002265 [DOI] [PubMed] [Google Scholar]

[joi220060r24] 24.Bagian JP, Paull DE. Handovers during anesthesia care: patient safety risk or opportunity for improvement? JAMA. 2018;319(2):125-127. doi: 10.1001/jama.2017.20602 [DOI] [PubMed] [Google Scholar]

[joi220060r25] 25.Mistry KP, Landrigtan CP, Goldman DA, Bates DW. Communication error during post-operative patient handoff in the pediatric intensive care unit. Crit Care Med. 2005;33(12):A12. doi: 10.1097/00003246-200512002-00047 [DOI] [Google Scholar]

[joi220060r26] 26.Haig KM, Sutton S, Whittington J. SBAR: a shared mental model for improving communication between clinicians. Jt Comm J Qual Patient Saf. 2006;32(3):167-175. doi: 10.1016/S1553-7250(06)32022-3 [DOI] [PubMed] [Google Scholar]

[joi220060r27] 27.Starmer AJ, O’Toole JK, Rosenbluth G, et al. ; I-PASS Study Education Executive Committee . Development, implementation, and dissemination of the I-PASS handoff curriculum: a multisite educational intervention to improve patient handoffs. Acad Med. 2014;89(6):876-884. doi: 10.1097/ACM.0000000000000264 [DOI] [PubMed] [Google Scholar]

[joi220060r28] 28.Starmer AJ, Spector ND, Srivastava R, et al. ; I-PASS Study Group . Changes in medical errors after implementation of a handoff program. N Engl J Med. 2014;371(19):1803-1812. doi: 10.1056/NEJMsa1405556 [DOI] [PubMed] [Google Scholar]

PERMALINK

Effect of Intraoperative Handovers of Anesthesia Care on Mortality, Readmission, or Postoperative Complications Among Adults

Melanie Meersch, MD

Raphael Weiss, MD

Mira Küllmar, MD

Lars Bergmann, MD

Astrid Thompson, MD

Leonore Griep, MD

Desiree Kusmierz, MD

Annika Buchholz, MD

Alexander Wolf, MD

Hartmuth Nowak, MD

Tim Rahmel, MD

Michael Adamzik, MD

Jan Gerrit Haaker, MD

Carina Goettker, MD

Matthias Gruendel, MD

Andre Hemping-Bovenkerk, MD

Ulrich Goebel, MD

Julius Braumann, MD

Irawan Wisudanto, MD

Manuel Wenk, MD

Darius Flores-Bergmann, MD

Andreas Böhmer, MD

Sebastian Cleophas, MD

Andreas Hohn, MD

Anne Houben, MD

Richard K Ellerkmann, MD

Jan Larmann, MD

Julia Sander, MD

Markus A Weigand, MD

Nicolas Eick, MD

Sebastian Ziemann, MD

Eike Bormann, MSc

Joachim Gerß, PhD

Daniel I Sessler, MD

Carola Wempe, PhD

Christina Massoth, MD

Alexander Zarbock, MD

Key Points

Question

Findings

Meaning

Abstract

Importance

Objective

Design, Setting, and Participants

Interventions

Main Outcomes and Measures

Results

Conclusions and Relevance

Trial Registration

Introduction

Methods

Study Design and Ethics

Patient Recruitment

Randomization

Procedures

Outcomes

Sample Size Calculation

Statistical Analysis

Results

Patients

Figure 1. Recruitment, Randomization, and Outcome Ascertainment of Patients in the HandiCAP Randomized Clinical Trial.

Table 1. Baseline Characteristics of Patients in the Primary Analysis of the HandiCAP Randomized Clinical Trial.

Table 2. Anesthesia Details.

Details of Anesthesia Care

Primary Outcome

Table 3. Clinical Outcomes.

Secondary Outcomes

Additional Analyses

Figure 2. Multivariable Regression Analysis for the Primary End Point.

Post Hoc Analysis and Outcomes

Discussion

Limitations

Conclusions

References

Associated Data

Supplementary Materials

ACTIONS