Clinical trial NCT02846467: Information Improvement for Surgical Patients Through Portable Video Media
Official title: Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Hyperplasia
Bladder Cancer
Keywords: Informed consent
Patient Education
Mobile applications
Lead sponsor: Hospital Universitario Puerto Real
Sponsor class: OTHER
Collaborators: name: University of Cadiz
First posted: 2016-07-27
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the comprehension of the Informed consent with the Standard Verbal Communication (SVC) versus Portable Video Media (PVM).

Detailed description: The informed consent (IC) is a fully ethical and legal consolidated requirement. IC is the voluntary authorization by a patient for surgical treatment (MeSH). The IC has to include: 1. What is and for what is it, 2. How is it made, 3. What effect will produce, 4. which patients will benefit, 5. Alternatives, 6. Risks and special situations.

The standard IC is based in written and verbal information, but the information provided is insufficient, leading to misunderstanding and even litigation.

Technology plays an important role in the improvement of IC: the portable video media, tablet, with the application (app) iURO assists the procedure through videos and illustrations.

To evaluate and measure the comprehension of the information that patients received, we elaborated and validated a "Questionnaire to evaluate the comprehension of IC" (the process was mounted as "Questionnaire for urology IC validation" in the poster session at the 17th International European Association of Urology Nurses (EAUN) Meeting, Munich-Germany).

The patients undergoing to bladder or prostate transurethral resection were selected. Afterwards they were randomized previous the interview, into two groups: patients informed by PVM with the app iUro (experimental group) versus patients with an SVC (control group). The questionnaire was used to compare the comprehension of the surgery immediately and 15 days after the surgery. The items regarding questionnaire were: information, utility of the intervention, side effects, complications, comorbidity, usefulness of information, anxiety and risks.

Eligibility criteria: Inclusion Criteria:

* Patients who are going to receive transurethral resection of bladder or prostate
* Patients, women and men, older than 18 years without any mental disability

Exclusion Criteria:

* Patients who refuse to participate in the study
* Patients who have inability to communicate in spanish.
* Several visual problems that limit the ability to read written material

Primary outcomes:
measure: Comprehension of informed consent
timeFrame: Prior to surgery
Secondary outcomes:
measure: Comprehension of informed consent
timeFrame: 15 days after surgery
Other outcomes:
Locations:
city: Puerto Real
country: Spain
facility: Urology Department of the University Hospital of Puerto Real
state: Cadiz
Study officials:
affiliation: Hospital Universitario Puerto Real
name: Sebastian Armijos Leon, Urologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Univesity of Cadiz
name: Federico Rodriguez Rubio, Urologist
role: STUDY_DIRECTOR
affiliation: Universidad de Zaragoza
name: Jorge Rioja Zuazu, Urologist
role: STUDY_CHAIR
References: