Effectiveness of Smartconsent in Improving Understanding of Informed Consent

Study Overview
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Brief Summary
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The general objective of the study is to assess whether the new smartconsent tool improves patients' understanding of the intervention to be performed, compared to standard practice. A randomized clinical trial will be conducted in 50 patients who will undergo LASER PROSTATIC ENUCLEATION.

Detailed Description
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Male patients aged between 50 and 70 years, belonging to the Hospital Universitario Araba who are going to undergo PROSTATIC LASER ENUCLEATION, and who attend urology consultation between December 2019 and December 2020, and who meet the inclusion criteria and none of the exclusion criteria. Inclusion criteria: Patients willing to receive information via tablet. Patients who know how to and can read. Exclusion criteria: -Not applicable. Main variable: score on the Multiple choice test questionnaire (designed specifically for each type of procedure, following the recommendations proposed by Kehoe, Jerard and Fathelrahman et al. and developed on the basis of the information that an informed consent should provide (1, 2), with 4 response options and only one correct answer. An average score will be calculated for each patient. This test evaluates the comprehension of the information provided through the informed consent.

Official Title
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Evaluation of the Effectiveness of Smartconsent to Improve Understanding of Informed Consent in Prostate Laser Enucleation Procedures

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: Smartconsent application
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients willing to receive information via tablet. Patients who know and can read. Exclusion Criteria: Not applicable

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: smartconsent group<br>Intervention group: : the principal investigator upon receiving the tablet enters with his/her user and password, registers his/her signature, selects the patient (anonymized), selects the intervention and then the tablet will be given to the patient and he/she will be instructed to follow the indications in order to be able to project the video and digitally sign the informed consent. | Procedure: Smartconsent application<br>* Patients asigned to smartconsent group will sign informed consent through a Tablet.<br>|
| Placebo Comparator: control group<br>Control group: The informed consent paper document (official format) will be printed with the patient's name, signed by the physician (principal investigator) and given to the patient to read and sign. | Other: Control group<br>* Patient asigned to control group will sing the informed consent in papel, as it is performed in clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score in the Multiple choice test questionnaire | Specifically designed for each type of procedure, following the recommendations proposed by Kehoe, Jerard and Fathelrahman et al. and developed on the basis of the information to be provided in an informed consent form, with 4 response options and only one correct answer | At the recruitment moment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with the informed consent proccess | based on three ad hoc designed items: Each item will be scored on a lipo Likert scale with 5 response options. | At the recruitment moment | 
| Ability to complete the informed consent form | Without the need for additional information from the healthcare professional. | At the recruitment moment | 
| Time required to complete the informed consent process (MIN). | The Smartphone stopwatch of the researchers participating in the study will be used for this purpose | At the recruitment moment | 
| Overall satisfaction with the informed consent process, | Through a three-item test, developed ad hoc by a group of researchers to assess satisfaction in a study with similar characteristics to ours. | At the recruitment moment | 
| Score in the System Usability Scale | In the SMARTCONSENT group only. he average System Usability Scale score is 68. If your score is under 68, then there are probably serious problems with your website usability which you should address. If your score is above 68, then you can relax a little bit. | At the recruitment moment |