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.
Study Type
OBSERVATIONAL
Enrollment
1,800
No intervention, observational only
Radboud UMC
Nijmegen, Netherlands
WITHDRAWNUniversity Hospital Basel
Basel, Switzerland
COMPLETEDLindenhofspital
Bern, Switzerland
RECRUITINGUniversity Hospital Berne
Bern, Switzerland
RECRUITINGCantonal Hospital Graubünden
Chur, Switzerland
RECRUITINGUniversity Hospital Geneva
Geneva, Switzerland
RECRUITINGUniversity Hospital Lausanne
Lausanne, Switzerland
RECRUITINGCantonal Hospital Lucerne
Lucerne, Switzerland
RECRUITINGRegional Hospital Lugano
Lugano, Switzerland
RECRUITINGUniversity Hospital Zurich
Zurich, Switzerland
RECRUITINGIntervention fidelity - component checklist completion
Checklist completion is defined as completeness of all ticks on the sign-out checklist taking into consideration the minimum standard.
Time frame: 2 months after the end of the implementation
Intervention fidelity - component quality of checklist performance
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.
Time frame: Up to four months after the implementation
Implementation fidelity - Quantitative and qualitative evaluation of critical implementation steps
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)
Time frame: Up to four months after the implementation
Intervention acceptability - extent of perception among stakeholders that the intervention is agreeable or satisfactory
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).
Time frame: Measured after the implementation
Adaptation - extent to which sign-out and documentation of iAEs have been locally adapted
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.
Time frame: Checklist and process modifications classified according to FRAME.
Appropriateness - extent to which staff perceive the intervention as being a good fit, relevant and compatible with their setting
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).
Time frame: Measured after the implementation
Feasibility - extent to which sign-out and documentation of iAEs can be successfully used or carried out within a given setting
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.
Time frame: Measured after the implementation
Sustainment
Sustainment is measured by comparing (full) adherence (defined as completeness of all ticks on the sign-out checklist) 12 months after implementation
Time frame: 12 months after the last patient out
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