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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

428 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2024-04-30

Brief Summary

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* 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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental group

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.

Group Type EXPERIMENTAL

Pre-procedural consultation and audiovisual tools

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No