Clinical trial NCT04063969: Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite
Official title: Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite and Its Effects on Radiation Safety Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Aortic Aneurysm, Abdominal
Keywords: Radiation safety
Radiation safety climate
Radiation safety behavior
Quality improvement
Patient safety
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Algemeen Ziekenhuis Maria Middelares
name: AZ Sint-Jan AV
name: Jan Yperman Ziekenhuis
name: GZA Ziekenhuizen Campus Sint-Augustinus
name: University Hospital, Ghent
First posted: 2019-08-21
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Endovascular team members: vascular surgeons, surgical trainees, operating nurses
* Patients undergoing elective endovascular repair of infrarenal abdominal aortic aneurysm

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Self-assessed radiation safety climate
timeFrame: Baseline measurement on study inclusion (Day 1)
measure: Self-assessed radiation safety behavior
timeFrame: Baseline measurement on study inclusion (Day 1)
measure: Self-assessed radiation safety knowledge and motivation
timeFrame: Baseline measurement on study inclusion (Day 1)
Secondary outcomes:
measure: Procedural radiation doses - Dose area product
timeFrame: Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion
measure: Procedural radiation doses - cumulative air kerma
timeFrame: Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion
measure: Procedural radiation doses - fluoroscopy time
timeFrame: Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Algemeen Ziekenhuis Maria Middelares
state: Oost Vlaanderen
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: Oost Vlaanderen
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge
state: West Vlaanderen
city: Ieper
country: Belgium
facility: Jan Yperman Ziekenhuis
state: West Vlaanderen
city: Antwerpen
country: Belgium
facility: GZA Campus Sint Augustinus
Study officials:
affiliation: Vascular surgeon
name: Isabelle Van Herzeele, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.