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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
52
Patients asigned to smartconsent group will sign informed consent through a Tablet.
Patient asigned to control group will sing the informed consent in papel, as it is performed in clinical practice
Imanol Merino
Vitoria-Gasteiz, Alava, Spain
Bioaraba Health Research Institute
Vitoria-Gasteiz, Alava, Spain
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
Time frame: At the recruitment moment
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.
Time frame: At the recruitment moment
Ability to complete the informed consent form
Without the need for additional information from the healthcare professional.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: At the recruitment moment
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