Information Improvement for Surgical Patients Through Portable Video Media

Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.

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).

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia; Bladder Cancer
• Intervention / Treatment: Other: Informed consent trough a portable video media; Other: Written informed consent

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.

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cadiz
    • Puerto Real, Cadiz, Spain, 11510
      • Urology Department of the University Hospital of Puerto Real

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Portable video media; Patients who receive informed consent trough portable video media around 10 minutes	Other: Informed consent trough a portable video media; Information provided to patients using the mobile application (iURO app); Other Names: iURO Application (App)
Active Comparator: Traditional IC; Patients who receive traditional IC (written consent) during 10 to 15 minutes	Other: Written informed consent; Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.; Other Names: Traditional informed consent; Standard verbal communication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comprehension of informed consent	Prior to surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Comprehension of informed consent	15 days after surgery

Collaborators and Investigators

• Sponsor: Hospital Universitario Puerto Real
• Collaborators: University of Cadiz
• Investigators: Principal Investigator: Sebastian Armijos Leon, Urologist, Hospital Universitario Puerto Real; Study Director: Federico Rodriguez Rubio, Urologist, Univesity of Cadiz; Study Chair: Jorge Rioja Zuazu, Urologist, Universidad de Zaragoza

Publications and helpful links

Helpful Links

• Abstract entitled: "MHealth (Mobile Health):The use of portable video media versus standard verbal communication in the informed consent", presented at 5th Meeting of Uro-Technology (ESUT) held in Athens, Greece

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Patient Education; Informed consent; Mobile applications
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: HospitalUPR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The database with the demographic and results of the participant is going to be available during the next six months. The information will be send with an email request.