Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes (HandiCAP)

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Adverse Effect of Handovers of Anesthesia Care
• Intervention / Treatment: Procedure: Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 1817
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany
    • University Hospital Aachen
  • Bochum, Germany
    • University Hospital Bochum
  • Dortmund, Germany
    • Klinikum Dortmund
  • Dortmund, Germany
    • St. Josefs-Hospital Dortmund-Hörde
  • Düsseldorf, Germany, 40489
    • Florence-Nightingale-Krankenhaus
  • Göttingen, Germany
    • Universitätsmedizin Göttingen, Klinik für Anästhesiologie
  • Heidelberg, Germany
    • University Hospital Heidelberg
  • Köln, Germany
    • Kliniken der Stadt Köln gGmbH, Klinik für Anästhesiologie und operative Intensivmedizin
  • Muenster, Germany, D-48149
    • University Hospital Muenster
  • Mönchengladbach, Germany
    • Kliniken Maria Hilf
  • Münster, Germany
    • St. Franziskus Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; No handover of anesthesia care	Procedure: Intervention; There will be one complete handover
No Intervention: Control group; Complete handover of anesthesia care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Combined endpoint consisting number of participants with all-cause mortality, readmission to any hospital or major postoperative complications	within 30 days of index surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with all-cause mortality		within 30 days of index surgery
Numer of participants with readmission to any hospital		within 30 days of index surgery
Number of participants with major postoperative complication	predefined postoperative complication including prolonged postoperative ventilation ≥ 48h, 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
Hospital length of stay		within 30 days of index surgery
Number of patients with ICU admission		within 30 days of index surgery
ICU length of stay		within 30 days of index surgery

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: Else Kröner Fresenius Foundation
• Investigators: Principal Investigator: Melanie Meersch, MD, PHD, University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2019
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: anesthesia; handover; intraoperative; adverse outcomes
• Other Study ID Numbers: 04-AnIt-18

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