Clinical trial NCT05461482: CLINTERVENTIONAL Trial: Impact of Clinical Consultations and Audiovisual Tools in Interventional Radiology
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Interventional Radiology
Physician-Patient Relations
Communication
Physician's Practice Patterns
Patient Satisfaction
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Knowledge from baseline to immediately preoperatively using a multi-choice questionnaire. Where the patient's knowledge was assessed related to the intervention.
timeFrame: From baseline at preoperative assessment to immediately preoperatively: 24 hours.
measure: Change in Anxiety from baseline to immediately preoperatively using a Visual analogue scale (0-10) and State-Trait Anxiety Inventory (20-80).
timeFrame: From baseline at preoperative assessment to immediately preoperatively: 24 hours.
measure: Change in satisfaction from baseline to immediately preoperatively using a Visual analogue scale (0-10).
timeFrame: From baseline at preoperative assessment to immediately preoperatively: 24 hours.
Secondary outcomes:
measure: Assessment the association between all of variables through a descriptive analysis using SPSS.
timeFrame: Through study completion: 18 months
measure: To contrast differences in the variables of both arms through a descriptive analysis using SPSS.
timeFrame: Through study completion: 18 months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
Study officials:
affiliation: Reina Sofia University Hospital
name: Pedro Blas García Jurado, MD
role: PRINCIPAL_INVESTIGATOR
References: