Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Aortic Aneurysm, Abdominal
• Intervention / Treatment: Other: Assessment of radiation safety climate; Other: Assessment of radiation safety behavior; Other: Assessment of radiation safety knowledge and motivation; Other: Data collection

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.

• Study Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2610
    • GZA Campus Sint Augustinus
  • Oost Vlaanderen
    • Ghent, Oost Vlaanderen, Belgium, 9000
      • Algemeen Ziekenhuis Maria Middelares
    • Ghent, Oost Vlaanderen, Belgium, 9000
      • Ghent University Hospital
  • West Vlaanderen
    • Brugge, West Vlaanderen, Belgium, 8000
      • Az Sint Jan Brugge
    • Ieper, West Vlaanderen, Belgium, 8900
      • Jan Yperman Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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; Other Names: Radiation safety climate rating tool; Other: 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; Other Names: Radiation safety behavior rating tool; Other: 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; Other Names: Radiation safety knowledge and motivation rating tool
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.	Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: University Hospital, Ghent; AZ Sint-Jan AV; Algemeen Ziekenhuis Maria Middelares; GZA Ziekenhuizen Campus Sint-Augustinus; Jan Yperman Ziekenhuis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 24, 2019
• Primary Completion (ACTUAL): August 20, 2019
• Study Completion (ACTUAL): August 20, 2019

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (ACTUAL): August 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Patient safety; Quality improvement; Radiation safety; Radiation safety climate; Radiation safety behavior
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: B670201837824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Research data will not be shared standard

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No