ClassIntra® for Better Outcomes in Surgery - CIBOSurg

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Perioperative Patient Safety

Intervention / Treatment
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* Other: Observational study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| before and after implementation cohort<br>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<br>* No intervention, observational only<br>|

What is the study measuring?
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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 |