CLINTERVENTIONAL Trial: Impact of Clinical Consultations and Audiovisual Tools in Interventional Radiology

Patient Satisfaction Clinical Trial

Official title:

CLINTERVENTIONAL Trial: A Randomized Controlled Two-arm Trial to Evaluate the Impact of Clinical Consultations and Audiovisual Tools in Patients Who Are Going to Undergo Interventional Radiology Procedures.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461482
• Other study ID #: Analisis RVI
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: Pedro Blas Garcia Jurado, MD
• Phone: 0034957010872
• Email: pedroblasgj[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• Objectives: To assess whether the implementation of pre-procedural consultations and the use of explanatory audiovisual tools prior to performing Vascular and Interventional Radiology procedures improve the understanding of interventions by patients, improve satisfaction with the information provided and reduce anxiety experienced by the procedure.

• Methods: We will conduct a two-arm randomized clinical trial that will include patients undergoing Vascular and Interventional Radiology procedures. After consent to participation by signing the informed consent, participants will be randomly assigned to the control group (patients to whom the information about the procedure is provided by the requesting physician) and to the experimental group (patients who, in addition to being informed by the requesting physicians, are attended by interventional radiologists in consultation after previously viewing explanatory videos of the interventions). Multi-choice questionnaires will be used to assess understanding and knowledge of the interventions and validated scales to measure satisfaction with the information provided and anxiety experienced. Knowledge and understanding of the intervention, satisfaction with the information transmitted and the method of transmission, as well as anxiety related to the intervention will be compared between the control group and the experimental group. The Student's t-test and the Mann-Whitney test will be used for the comparison of quantitative variables and the chi-square test and Fisher's exact test for the comparison of qualitative variables. Regression analysis will be used to evaluate associations between variables.

• Expected results: To demonstrate that the implementation of pre-procedural consultations attended by interventional radiologists and the use of educational audiovisual tools prior to performing Vascular and Interventional Radiology procedures improve the understanding of interventions by patients, their satisfaction with the information provided and reduces the anxiety experienced for the procedure.

• Potential impact: It is the first clinical trial that analyzes the usefulness of pre-procedural consultations and audiovisual tools in Vascular and Interventional Radiology, so its results will be very interesting to help standardize clinical practice in Vascular and Interventional Radiology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 428
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

To be eligible, each patient must meet one of the inclusion criteria and none of the exclusion criteria.

Inclusion Criteria:

• Patients who are going to undergo one of the following elective vascular interventional procedures: tunneled cuffed catheter placement, fistulography and endovascular treatment of hemodialysis arteriovenous fistulas, vascular recanalization procedures and vascular embolization procedures.

• Patients undergoing one of the following elective nonvascular interventional procedures: image-guided percutaneous biopsies, percutaneous fluid and abscess drainage, percutaneous transhepatic biliary drainage and percutaneous nephrostomy.

Exclusion Criteria:

• Patients under 18 years of age.

• Patients who require the participation of a third party for informed consent.

• Pregnant patients.

• Patients undergoing urgent interventional procedures.

• Patients with allergy or intolerance to mepivacaine, tramadol, midazolam or fentanyl.

• Patients who do not understand and speak Spanish properly.

• Patients with deafness or blindness.

Related Conditions & MeSH terms

• Communication
• Interventional Radiology
• Patient Satisfaction
• Physician's Practice Patterns
• Physician-Patient Relations

Intervention

Other:
• Pre-procedural consultation and audiovisual tools
In addition to the information provided by the referring physician, an interventional radiologist will assist the patient in a consultation before the intervention to inform him, explaining the objective of the intervention, its risks and benefits, and possible alternatives and doubts related to the intervention. In this group, educational videos will be used, one for each type of intervention, which will complement the explanations of the physician. The videos will aim to present in an understandable way the preparation for the intervention, its objective, the benefits and risks that derive from it and what you can expect once it has been carried out. Patients will have access to the videos before attending the consultation and will view them before being seen by the interventional radiologist.

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofia	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knowledge from baseline to immediately preoperatively using a multi-choice questionnaire. Where the patient's knowledge was assessed related to the intervention.	It will be assessed if the preparation for the intervention, the indication, the intervention itself, the subsequent care and the benefits, risks and alternatives are known and understood. It will be analyzed using a multi-choice questionnaire.	From baseline at preoperative assessment to immediately preoperatively: 24 hours.
Primary	Change in Anxiety from baseline to immediately preoperatively using a Visual analogue scale (0-10) and State-Trait Anxiety Inventory (20-80).	It will be assessed if the preparation for the intervention, the indication, the intervention itself, the subsequent care and the benefits, risks and alternatives are known and understood. It will be analyzed using a multi-choice questionnaire.	From baseline at preoperative assessment to immediately preoperatively: 24 hours.
Primary	Change in satisfaction from baseline to immediately preoperatively using a Visual analogue scale (0-10).	It will be assessed if the preparation for the intervention, the indication, the intervention itself, the subsequent care and the benefits, risks and alternatives are known and understood. It will be analyzed using a multi-choice questionnaire.	From baseline at preoperative assessment to immediately preoperatively: 24 hours.
Secondary	Assessment the association between all of variables through a descriptive analysis using SPSS.	It will be assessed the association between demographic variables, type of intervention, personal history, intervention group, anxiety related to the intervention, level of knowledge and understanding of the intervention, type of anesthesia, and degree of sedation with the pain intensity during the intervention, with the level of tolerance of the intervention and with the level of satisfaction with the intervention performed	Through study completion: 18 months
Secondary	To contrast differences in the variables of both arms through a descriptive analysis using SPSS.	Comparative analysis of the duration of the intervention, the intensity of the pain perceived by the patient during the procedure, the level of tolerance of the intervention and the level of satisfaction with the intervention carried out in the two groups of patients.	Through study completion: 18 months