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

• ClinicalTrials.gov Identifier: NCT04016454
• Recruitment Status: Completed
• First Posted: July 11, 2019
• Last Update Posted: January 5, 2022
• Sponsor: University Hospital Muenster
• Collaborator: Else Kröner Fresenius Foundation
• Information provided by (Responsible Party): University Hospital Muenster

Tracking Information

• First Submitted Date: June 27, 2019
• First Posted Date: July 11, 2019
• Last Update Posted Date: January 5, 2022
• Actual Study Start Date: June 21, 2019
• Actual Primary Completion Date: July 31, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 9, 2019): Combined endpoint consisting number of participants with all-cause mortality, readmission to any hospital or major postoperative complications [ Time Frame: within 30 days of index surgery ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 9, 2019)

• Number of participants with all-cause mortality [ Time Frame: within 30 days of index surgery ]
• Numer of participants with readmission to any hospital [ Time Frame: within 30 days of index surgery ]
• Number of participants with major postoperative complication [ Time Frame: within 30 days of index surgery ]
  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
• Hospital length of stay [ Time Frame: within 30 days of index surgery ]
• Number of patients with ICU admission [ Time Frame: within 30 days of index surgery ]
• ICU length of stay [ Time Frame: within 30 days of index surgery ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes
• Official Title: Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition

• Anesthesia
• Adverse Effect of Handovers of Anesthesia Care

Intervention

Procedure: Intervention

There will be one complete handover

Study Arms

• Experimental: Intervention group
  No handover of anesthesia care
  Intervention: Procedure: Intervention
• No Intervention: Control group
  Complete handover of anesthesia care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 4, 2022): 1817
• Original Estimated Enrollment (submitted: July 9, 2019): 1814
• Actual Study Completion Date: July 31, 2021
• Actual Primary Completion Date: July 31, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT04016454
• Other Study ID Numbers: 04-AnIt-18
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University Hospital Muenster
• Study 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

• PRS Account: University Hospital Muenster
• Verification Date: December 2021