ClassIntra® for Better Outcomes in Surgery - CIBOSurg
- Conditions
- Perioperative Patient Safety
- Interventions
- Other: Observational study
- Registration Number
- NCT05818332
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
Intra- and postoperative adverse events (iAEs and pAEs) occur in up to one third of all patients undergoing surgery. They are devastating to patients and costly to health care systems. Their number tends to increase due to the rising complexity of both the patient's risk profile and the surgical procedure. Postoperative deaths have been identified to be the third most frequent cause of death worldwide. Teamwork in surgery has been attributed to have a potentially great impact on avoiding postoperative morbidity. Up to 50% of all adverse in-hospital events were rated to be potentially preventable. However, their prevention typically requires a change in systems and individual behaviour. Standardised assessments of iAEs and pAEs are a prerequisite to develop and define strategies for prevention of AEs. While awareness of pAEs has highly risen through the introduction of the Clavien-Dindo classification, the most widely used classification for grading severity of pAEs, the relevance of transparent monitoring of iAEs is still highly undervalued.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1800
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description before and after implementation cohort Observational study 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)
- Primary Outcome Measures
Name Time Method Intervention fidelity - component checklist completion 2 months after the end of the implementation Checklist completion is defined as completeness of all ticks on the sign-out checklist taking into consideration the minimum standard.
- Secondary Outcome Measures
Name Time Method Intervention fidelity - component quality of checklist performance Up to four months after the implementation Quality of the sign-out will be measured with the WHO behaviourally anchored rating scale (WHOBARS):
Quality will be measured in a random sample of 20-25%, assessed in those centres with well-established sign-out in the baseline period and in all centres in the after-implementation phase.Implementation fidelity - Quantitative and qualitative evaluation of critical implementation steps Up to four months after the implementation Quantitative and qualitative evaluation of critical implementation steps followed or not (and why not) by each site, according to the proposed/designed implementation plan (template)
Intervention acceptability - extent of perception among stakeholders that the intervention is agreeable or satisfactory Measured after the implementation Acceptability is the extent of perception among stakeholders that the intervention is agreeable or satisfactory. It will be measured according to the Acceptability of Intervention Measure (AIM).
Adaptation - extent to which sign-out and documentation of iAEs have been locally adapted Checklist and process modifications classified according to FRAME. Adaptation is the extent to which sign-out and documentation of iAEs have been locally adapted. It will be measured by comparing the local checklists with the minimum standard sign-out.
Appropriateness - extent to which staff perceive the intervention as being a good fit, relevant and compatible with their setting Measured after the implementation Appropriateness is the extent to which staff perceive the intervention as being a good fit, relevant and compatible with their setting. It will be measured by the Intervention Appropriateness Measure (IAM).
Feasibility - extent to which sign-out and documentation of iAEs can be successfully used or carried out within a given setting Measured after the implementation Feasibility is the extent to which sign-out and documentation of iAEs can be successfully used or carried out within a given setting. It will be measured by the Feasibility of Intervention Measure FIM.
Sustainment 12 months after the last patient out Sustainment is measured by comparing (full) adherence (defined as completeness of all ticks on the sign-out checklist) 12 months after implementation
Trial Locations
- Locations (10)
Cantonal Hospital Lucerne
🇨🇭Lucerne, Switzerland
Regional Hospital Lugano
🇨🇭Lugano, Switzerland
University Hospital Zurich
🇨🇭Zürich, Switzerland
University Hospital Geneva
🇨🇭Geneva, Switzerland
Radboud UMC
🇳🇱Nijmegen, Netherlands
University Hospital Basel
🇨🇭Basel, Switzerland
Lindenhofspital
🇨🇭Berne, Switzerland
University Hospital Berne
🇨🇭Bern, Switzerland
Cantonal Hospital Graubünden
🇨🇭Chur, Switzerland
University Hospital Lausanne
🇨🇭Lausanne, Switzerland