Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite
NCT ID: NCT04063969
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
92 participants
OBSERVATIONAL
2019-01-24
2019-08-20
Brief Summary
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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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Conditions
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Endovascular team members
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.
Assessment of radiation safety climate
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
Assessment of radiation safety behavior
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
Assessment of radiation safety knowledge and motivation
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
Vascular surgical patients
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.
Data collection
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
Interventions
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Assessment of radiation safety climate
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
Assessment of radiation safety behavior
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
Assessment of radiation safety knowledge and motivation
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
Data collection
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active at one of the participating hospitals
* Patient undergoing elective endovascular repair of infrarenal abdominal aortic aneurysm
Exclusion Criteria
* Additional interventional procedures (iliac aneurysm, treatment of peripheral vessel disease)
18 Years
ALL
No
Sponsors
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Algemeen Ziekenhuis Maria Middelares
OTHER
AZ Sint-Jan AV
OTHER
Jan Yperman Ziekenhuis
OTHER
GZA Ziekenhuizen Campus Sint-Augustinus
OTHER
University Hospital, Ghent
OTHER
University Ghent
OTHER
Responsible Party
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Principal Investigators
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Isabelle Van Herzeele, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Vascular surgeon
Locations
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Algemeen Ziekenhuis Maria Middelares
Ghent, Oost Vlaanderen, Belgium
Ghent University Hospital
Ghent, Oost Vlaanderen, Belgium
AZ Sint Jan Brugge
Bruges, West Vlaanderen, Belgium
Jan Yperman Ziekenhuis
Ieper, West Vlaanderen, Belgium
GZA Campus Sint Augustinus
Antwerp, , Belgium
Countries
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References
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Griffin MA, Neal A. Perceptions of safety at work: a framework for linking safety climate to safety performance, knowledge, and motivation. J Occup Health Psychol. 2000 Jul;5(3):347-58. doi: 10.1037//1076-8998.5.3.347.
Other Identifiers
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B670201837824
Identifier Type: -
Identifier Source: org_study_id