Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite

Study Overview
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Brief Summary
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This study aims to measure the radiation safety climate in the hybrid angiography suite using self-assessment and to investigate the relationship of radiation safety climate with their self-reported safety behaviors. The hypothesis is that a radiation safety climate does exist and can be measured using self-assessment. Additionally, it is expected that the radiation safety climate positively influences radiation safety behaviors.

Detailed Description
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Radiation safety in the hybrid angiography suite is a primordial safety component which is relevant for endovascular team members and patients. To date, many interventions which aim to improve radiation safety habits of an endovascular team focus on improving technology and team radiation safety knowledge. Safety literature has indicated that a safety climate can be identified as the shared perceptions of team members or workers about the safety in their workspace and that this safety climate is closely related to safety behaviors and outcomes. In endovascular specialties, the concept of a radiation safety climate remains unexplored. Therefore, this study aims to measure the radiation safety climate in a diverse pool of endovascular team members from different hospitals, using self-assessment questionnaires and to investigate the relationship of radiation safety climate with their self-reported safety behaviors.

Official Title
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Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite and Its Effects on Radiation Safety Performance

Conditions
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Healthy Volunteers, Aortic Aneurysm, Abdominal

Intervention / Treatment
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* Other: Assessment of radiation safety climate
* Other: Assessment of radiation safety behavior
* Other: Assessment of radiation safety knowledge and motivation
* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Endovascular team member group Inclusion Criteria: Vascular surgeon OR surgical trainee OR operating nurse Active at one of the participating hospitals Exclusion Criteria: No exclusion criteria apply to this study. Patient group Inclusion Criteria Patient undergoing elective endovascular repair of infrarenal abdominal aortic aneurysm Exclusion criteria Emergency repair (ruptured aneurysm) Additional interventional procedures (iliac aneurysm, treatment of peripheral vessel disease)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endovascular team members<br>All vascular surgeons, surgical trainees, nurses active in the hybrid angiography suite at one of the participating centers will be invited to participate in the study. All participating team members complete an online questionnaire containing an assessment of their perceived radiation safety climate (28 items, 5 dimensions), radiation safety behaviors(2 items, 2 dimensions), radiation safety knowledge (single item) and radiation safety motivation (single item). All data will be stored pseudonymized. | Other: Assessment of radiation safety climate<br>* The rating tool contains 28 statements which cover 5 dimensions (Leadership, communication, commitment, resources, risk awareness) of the radiation safety climate. Participants are asked to indicate on a scale of 1 (completely disagree) - 3 (neutral) - 5 (completely agree) whether they agree with each statement. A composite radiation safety climate score is calculated by adding ratings on all items. Minimum scale score 28 - Maximum scale score 140<br>* Other names: Radiation safety climate rating tool;Other: Assessment of radiation safety behavior<br>* The rating tool contains 2 statements which cover 2 dimensions of the radiation safety behavior. Participants are asked to indicate on a scale of 1 (completely disagree) - 3 (neutral) - 5 (completely agree) whether they agree with each statement. A composite radiation safety behavior score is calculated by adding ratings on both items Minimum scale score 2 - Maximum scale score 10<br>* Other names: Radiation safety behavior rating tool;Other: Assessment of radiation safety knowledge and motivation<br>* The rating tool contains 2 statements which cover the radiation safety knowledge and behavior. Participants are asked to indicate on a scale of 1 (completely disagree) - 3 (neutral) - 5 (completely agree) whether they agree with each statement. Minimum item score 1 - maximum item score 5<br>* Other names: Radiation safety knowledge and motivation rating tool;|
| Vascular surgical patients<br>In each center, five patients undergoing primary elective endovascular repair for an infrarenal abdominal aortic aneurysm (EVAR) will be enrolled in the study. For each participating patient, a set of demographical (BMI, case difficulty, ASA-grade,etc.), procedure-related (procedure duration, contrast use, etc.) and radiation dose parameters (DAP, cumulative air kerma) will be collected and stored in a pseudonymized way. Participation in this study has no effect on the interventional procedure, or the chosen approach. | Other: Data collection<br>* Collection of patient-related data points Demographic information: ASA-classification, BMI Procedure related information: Procedural time, approach, contrast usage case difficulty Radiation safety parameters: Air Kerma, DAP, fluoroscopy time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-assessed radiation safety climate | Radiation safety climate using radiation safety climate tool | Baseline measurement on study inclusion (Day 1) | 
| Self-assessed radiation safety behavior | Radiation safety behavior using radiation safety behavior tool | Baseline measurement on study inclusion (Day 1) | 
| Self-assessed radiation safety knowledge and motivation | Radiation safety knowledge and motivation using rating tool | Baseline measurement on study inclusion (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural radiation doses - Dose area product | Procedural dose area product (DAP) | Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion | 
| Procedural radiation doses - cumulative air kerma | Procedural cumulative air kerma (CAK) | Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion | 
| Procedural radiation doses - fluoroscopy time | Procedural fluoroscopy time | Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation safety, Radiation safety climate, Radiation safety behavior, Quality improvement, Patient safety