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

NCT05461482 | Unknown

• 1 other identifier: Analisis RVI
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (2)

• Assessment the association between all of variables through a descriptive analysis using SPSS.

  Through study completion: 18 months

• To contrast differences in the variables of both arms through a descriptive analysis using SPSS.

  Through study completion: 18 months

Study Arms (2)

Control group

NO INTERVENTION

The physician requesting the intervention will be responsible for informing the patient, explaining the purpose of the intervention, its risks and benefits, and possible alternatives and doubts related to the intervention.

Experimental group

EXPERIMENTAL

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.

Other: Pre-procedural consultation and audiovisual tools

Interventions

Pre-procedural consultation and audiovisual tools OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Related Publications (2)

• Garcia Jurado PB, Espejo Herrero JJ, Lombardo Galera MS, Perez Montilla ME, Barranco Acosta S, Garcia-Revillo Garcia J, Font Ugalde P, Alvarez Benito M. Impact of the clinical role of interventional radiologists: results of the CLINTERVENTIONAL randomized controlled trial. Eur Radiol. 2025 Dec;35(12):7658-7668. doi: 10.1007/s00330-025-11757-0. Epub 2025 Jun 17.

  PMID: 40526354 DERIVED

• Garcia Jurado PB, Espejo Herrero JJ, Lombardo Galera MS, Perez Montilla ME, Barranco Acosta S, Garcia-Revillo J, Font Ugalde P, Alvarez Benito M. CLINTERVENTIONAL protocol: a randomized controlled trial to evaluate clinical consultations and audiovisual tools for interventional radiology. Eur Radiol Exp. 2025 Jan 15;9(1):6. doi: 10.1186/s41747-024-00545-y.

  PMID: 39812733 DERIVED

MeSH Terms

Conditions

Communication; Patient Satisfaction

Condition Hierarchy (Ancestors)

Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Pedro Blas García Jurado, MD

  Reina Sofia University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Blas Garcia Jurado, MD

CONTACT

0034957010872; pedroblasgj@gmail.com

Ana Isabel Cerro

CONTACT

0034957010872; ana.cerro@imibic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: July 18, 2022
• Study Start: August 31, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 5, 2024

Record last verified: 2023-10

Locations

ES (1)