ClassIntra® for Better Outcomes in Surgery - CIBOSurg (CIBOSurg)

Implementation of the Sign-out Phase of the WHO Checklist 'Safe Surgery' With Routine Recording of Intraoperative Adverse Events According to ClassIntra® and a Multifaceted, Tailored Implementation Strategy: a Collaborative Before-and-after Project Using a Hybrid Implementation - Effectiveness Approach

Intra- and postoperative adverse events (iAEs/pAEs) occur in up to one third of all patients, may be devastating to patients and costly to health care systems. Up to 50% of these events are potentially preventable. As iAEs are highly associated with pAEs, systematic and routine recording of iAEs and discussing them during the sign-out of the WHO Surgical Safety checklist (WHO SSC) is a prerequisite for diminishing or avoiding pAEs. However, in contrary to the first two parts of the WHO SSC, adherence with the last part, the sign-out, is only about 50%. Hence, the aim of this project is to increase adherence and quality of the performance of the WHO SSC and to implement routine recording of iAEs during the sign-out to improve patient safety and quality of care and, ultimately, reduce healthcare costs. Implementation science principles will be applied with a hybrid implementation-effectiveness approach and a multifaceted, tailored implementation strategy, which will be co-developed involving all relevant stakeholders.

Study Overview

• Status: Recruiting
• Conditions: Perioperative Patient Safety
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Salome Dell-Kuster, PD Dr. med.; Phone Number: 0041 61 328 64 74; Email: salome.dell-kuster@usb.ch

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Withdrawn
    • Radboud UMC
• Switzerland
  • Basel, Switzerland
    • Completed
    • University Hospital Basel
  • Bern, Switzerland
    • Recruiting
    • University Hospital Berne
    • Contact: Andreas Vogt, Prof. Dr. med.; Phone Number: 031 632 42 17; Email: andreas.vogt@insel.ch
  • Berne, Switzerland
    • Recruiting
    • Lindenhofspital
    • Contact: Jan Wiegand, Dr. med.
  • Chur, Switzerland
    • Recruiting
    • Cantonal Hospital Graubünden
    • Contact: Christoph Burkhart, Dr. med.; Phone Number: 081 255 20 06; Email: christoph.burkhart@ksgr.ch
  • Lausanne, Switzerland
    • Recruiting
    • University Hospital Lausanne
    • Contact: Dieter Hahnloser, Prof. Dr. med.; Phone Number: 021 314 66 31; Email: dieter.hahnloser@chuv.ch
  • Lucerne, Switzerland
    • Recruiting
    • Cantonal Hospital Lucerne
    • Contact: Markus Gass, Dr. med.; Phone Number: 041 205 45 39; Email: markus.gass@luks.ch
  • Lugano, Switzerland
    • Recruiting
    • Regional Hospital Lugano
    • Contact: Nicola Ledingham, Dr. med.
  • Zürich, Switzerland
    • Recruiting
    • University Hospital Zurich
    • Contact: Valentin Neuhaus, Prof. Dr. med.; Phone Number: 044 255 23 99; Email: valentin.neuhaus@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All in-hospital patients (consecutive) undergoing surgery in the operating room with anaesthesia involvement

Description

Inclusion Criteria:

- All in-hospital patients (consecutive or random sample) undergoing surgery from general surgery, vascular, surgery, orthopaedics/traumatology and urology in the operating room with anaesthesia involvement

Exclusion Criteria:

• Patients undergoing one-day-surgery (with or without anaesthesia-involvement)
• Procedures without anaesthesia-involvement (in- or out-patient)
• ASA risk classification (ASA) VI patients (brain-death, organ-donor)
• Follow-up procedure of a patient already included in the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
before and after implementation cohort; consecutive cohort of 1000 surgical patients (baseline) consecutive cohort of 1000 surgical patients (after implementation with a multifaceted, tailored implementation strategy to improve adherence to the WHO SSC and routine recording of iAEs)	Other: Observational study; No intervention, observational only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full adherence	number of surgeries with full adherence with the sign-out	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation fidelity	number of surgeries performing the WHO checklist including ClassIntra® with fidelity	through study completion, an average of 6 months
postoperative adverse events	Comparison between 'after' and 'before' period	through in-hospital stay, an average of 2 days
postoperative adverse events	Comparison between 'after' and 'before' period	90 days

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Req-2023-00330

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No