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

NCT ID: NCT04582513

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-29

Study Completion Date

2021-11-30

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Major Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

AnCHor-Checklist implementation

Intervention Type OTHER

a standardized checklist using the SBAR concept according to the recommendations of the DGAI

Interventions

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AnCHor-Checklist implementation

a standardized checklist using the SBAR concept according to the recommendations of the DGAI

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Jan Larmann

Attending Anaesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Larmann, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Departement of Anaesthesiology, Heidelberg University Hospital

Locations

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Department of Anaesthesiology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jan Larmann, MD PhD

Role: CONTACT

06221/5636351

Julia Sander, MD

Role: CONTACT

06221/5636351

Facility Contacts

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Jan Larmann, MD/PhD

Role: primary

+49 (0)6221 56 ext. 39447

References

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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.

Reference Type BACKGROUND
PMID: 29318277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25440620 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25102312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27466034 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22653454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24448849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25625256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19342529 (View on PubMed)

Other Identifiers

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AnCHor

Identifier Type: -

Identifier Source: org_study_id