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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| before and after implementation cohort | consecutive cohort of 900 surgical patients (baseline) consecutive cohort of 900 surgical patients (after implementation with a multifaceted, tailored implementation strategy to improve adherence to the WHO SSC and routine recording of iAEs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study | Other | No intervention, observational only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intervention fidelity - component checklist completion | Checklist completion is defined as completeness of all ticks on the sign-out checklist taking into consideration the minimum standard. | 2 months after the end of the implementation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to four months after the implementation |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative conclusions | Qualitative conclusions about the effectiveness of the employed implementation strategy. | Longitudinal data collection before, during and after the implementation |
| Characterising themes |
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:
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All in-hospital patients (consecutive) undergoing surgery in the operating room with anaesthesia involvement
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salome Dell-Kuster, Prof. Dr. med. | Contact | +41 61 328 64 74 | salome.dell-kuster@usb.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud UMC | Withdrawn | Nijmegen | Netherlands | |||
| University Hospital Basel |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| 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) | 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). | 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. | 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). | 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. | 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 | 12 months after the last patient out |
Themes characterising the factors that influenced the observed implementation processes, based on the results from the contextual analysis.
| Longitudinal data collection before, during and after the implementation |
| Comprehensive Complication Index (CCI®) | CCI® (Comprehensive Complication Index) is the weighted sum of all pAEs according to Clavien-Dindo. It will be assessed at hospital discharge and at 90 days after surgery. | Difference in CCI® before and after the implementation at hospital discharge and at 90 days after surgery |
| Severe iAEs according to ClassIntra® | Severe iAEs according to ClassIntra® are defined as greater than or equal to grade III. | Difference in number of severe iAEs before and after the implementation |
| Total number of iAEs according to ClassIntra® | Total number of iAEs according to ClassIntra® occurring in the baseline and the after implementation period. | Difference in total number of iAEs before and after the implementation |
| Severe pAEs according to Clavien-Dindo | Severe pAEs according to Clavien-Dindo are defined as greater than or equal to grade IIIa. They will be assessed at hospital discharge and at 90 days after surgery. | Difference in number of severe iAEs before and after the implementation |
| Total number of pAEs according to Clavien-Dindo | Total number of pAEs according to Clavien-Dindo occurred in the baseline and the after implementation period. They will be assessed at hospital discharge and at 90 days after surgery. | Difference in total number of pAEs before and after the implementation |
| Number of resulting actions due to the routine recording and discussion of iAEs during the sign-out | Resulting actions are e.g. preventive measures for anticipated pAEs. | Difference in number of resulting actions before and after the implementation |
| Length of hospital stay | Length of hospital stay will be measured in days. | Difference in length of hospital stay before and after the implementation |
| Completed |
| Basel |
| Switzerland |
| Lindenhofspital | Recruiting | Bern | Switzerland |
|
| University Hospital Berne | Recruiting | Bern | Switzerland |
|
| Cantonal Hospital Graubünden | Recruiting | Chur | Switzerland |
|
| University Hospital Geneva | Recruiting | Geneva | Switzerland |
|
| University Hospital Lausanne | Recruiting | Lausanne | Switzerland |
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| Cantonal Hospital Lucerne | Recruiting | Lucerne | Switzerland |
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| Regional Hospital Lugano | Recruiting | Lugano | Switzerland |
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| University Hospital Zurich | Recruiting | Zurich | Switzerland |
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