Clinical trial NCT04016454: Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes
Official title: Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Adverse Effect of Handovers of Anesthesia Care
Keywords: handover
intraoperative
anesthesia
adverse outcomes
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Else Kröner Fresenius Foundation
First posted: 2019-07-11
Enrollment: 1817
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In order to investigate the impact of handover of anesthesia care on adverse postoperative outcomes, patients will be assigned to the two randomization groups:

1. Intervention group: handover of anesthesia
2. Control group: no handover of anesthesia
Primary purpose: TREATMENT

Brief summary: Our goal is to conduct a prospective, national, randomized-controlled, multicenter trial to investigate the effect of handover of anesthesia care on the occurrence of adverse outcomes in the perioperative period.

Detailed description: Intraoperative handover of anesthesia care frequently occurs in clinical routine. Communication between the two anesthesiologists plays a pivotal role for the continuation of anesthesia care. The outgoing clinician must inform the incoming clinician in a short period of time about the important pre- and intraoperative facts and about the surgery while continuing to provide patient care. Contributing factors to inadequate communication during handoffs include insufficient or misleading information, busy and distractive environment, ineffective communication methods, lack of time, lack of standardized procedures, and insufficient staffing. It is estimated that the majority of adverse events in health care involve miscommunication during the handoff between physicians and perhaps other health care practitioners (https://www.jointcommission.org/hot_topics_toc/).

The goal is to conduct a prospective, national, randomized-controlled, multicenter trial to investigate the effect of handover of anesthesia care on the occurrence of adverse outcomes in the perioperative period. The investigators hypothesizes that handover of anesthesia care does increase the risk for adverse outcomes. The primary outcome parameter is a combined endpoint consisting of all-cause mortality, readmission to any hospital, or major postoperative complications (including prolonged postoperative ventilation ≥ 48 h, 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 endpoints are the individual criteria of the primary endpoint, hospital length of stay, ICU admission, and ICU length of stay. As the currently available data on handover of anesthesia care have not been obtained from prospective, randomized controlled trials, the results of the Handicap trial will bring new insights to anesthesia care to improve patients' outcome.

Eligibility criteria: 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)
* ASA 3-4
* Informed consent

Exclusion Criteria:

* 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
* Persons with any kind of dependency on the investigator or employed by the investigator

Primary outcomes:
measure: Combined endpoint consisting number of participants with all-cause mortality, readmission to any hospital or major postoperative complications
timeFrame: within 30 days of index surgery
Secondary outcomes:
measure: Number of participants with all-cause mortality
timeFrame: within 30 days of index surgery
measure: Numer of participants with readmission to any hospital
timeFrame: within 30 days of index surgery
measure: Number of participants with major postoperative complication
timeFrame: within 30 days of index surgery
measure: Hospital length of stay
timeFrame: within 30 days of index surgery
measure: Number of patients with ICU admission
timeFrame: within 30 days of index surgery
measure: ICU length of stay
timeFrame: within 30 days of index surgery
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
city: Bochum
country: Germany
facility: University Hospital Bochum
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Dortmund
country: Germany
facility: St. Josefs-Hospital Dortmund-Hörde
city: Düsseldorf
country: Germany
facility: Florence-Nightingale-Krankenhaus
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen, Klinik für Anästhesiologie
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Köln
country: Germany
facility: Kliniken der Stadt Köln gGmbH, Klinik für Anästhesiologie und operative Intensivmedizin
city: Muenster
country: Germany
facility: University Hospital Muenster
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf
city: Münster
country: Germany
facility: St. Franziskus Hospital
Study officials:
affiliation: University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine
name: Melanie Meersch, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meersch M, Weiss R, Kullmar M, Bergmann L, Thompson A, Griep L, Kusmierz D, Buchholz A, Wolf A, Nowak H, Rahmel T, Adamzik M, Haaker JG, Goettker C, Gruendel M, Hemping-Bovenkerk A, Goebel U, Braumann J, Wisudanto I, Wenk M, Flores-Bergmann D, Bohmer A, Cleophas S, Hohn A, Houben A, Ellerkmann RK, Larmann J, Sander J, Weigand MA, Eick N, Ziemann S, Bormann E, Gerss J, Sessler DI, Wempe C, Massoth C, Zarbock A. Effect of Intraoperative Handovers of Anesthesia Care on Mortality, Readmission, or Postoperative Complications Among Adults: The HandiCAP Randomized Clinical Trial. JAMA. 2022 Jun 28;327(24):2403-2412. doi: 10.1001/jama.2022.9451.