Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite

NCT04063969 | Completed

• 1 other identifier: B670201837824
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 5

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.

Conditions

Healthy Volunteers; Aortic Aneurysm, Abdominal

Keywords

Radiation safety; Radiation safety climate; Radiation safety behavior; Quality improvement; Patient safety

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Procedural radiation doses - Dose area product

  Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion

• Procedural radiation doses - cumulative air kerma

  Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion

• Procedural radiation doses - fluoroscopy time

  Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion

Study Arms (2)

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; Other: Assessment of radiation safety behavior; Other: Assessment of radiation safety knowledge and motivation

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

Interventions

Assessment of radiation safety climate OTHER

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

Also known as: Radiation safety climate rating tool

Endovascular team members

Assessment of radiation safety behavior OTHER

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

Also known as: Radiation safety behavior rating tool

Endovascular team members

Assessment of radiation safety knowledge and motivation OTHER

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

Also known as: Radiation safety knowledge and motivation rating tool

Endovascular team members

Data collection OTHER

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

Vascular surgical patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Vascular surgeon OR surgical trainee OR operating nurse
• Active at one of the participating hospitals

You may not qualify if:

• Patient undergoing elective endovascular repair of infrarenal abdominal aortic aneurysm
• Emergency repair (ruptured aneurysm)
• Additional interventional procedures (iliac aneurysm, treatment of peripheral vessel disease)

Sponsors & Collaborators

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

Study Sites (5)

Algemeen Ziekenhuis Maria Middelares

Ghent, Oost Vlaanderen, 9000, Belgium

Location

Ghent University Hospital

Ghent, Oost Vlaanderen, 9000, Belgium

Location

AZ Sint Jan Brugge

Bruges, West Vlaanderen, 8000, Belgium

Location

Jan Yperman Ziekenhuis

Ieper, West Vlaanderen, 8900, Belgium

Location

GZA Campus Sint Augustinus

Antwerp, 2610, Belgium

Location

Related Publications (1)

• 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.

  PMID: 10912498 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Isabelle Van Herzeele, MD, PhD

  Vascular surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 21, 2019
• Study Start: January 24, 2019
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5)