Desktop Versus Mobile Data Collection in Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Paper-based data collection for prospective clinical trials is associated with a poor quality of data collection. This typically involves missing or wrong data entry or a low recruitment rate, mainly due to the cumbersome and uncontrolled data collection. Electronic data collection is associated with improved quality of data entry in the cases of Electronic Patient Records (EPR) and patient handover among doctors during night and day shifts. However, a comprehensive direct comparison between web-based desktop personal computer (PC) and mobile (e.g. iPad) data collection has not yet been reported. The purpose of this prospective trial is to compare the users' experience with the web-based desktop PC and mobile data collection (iPad) tools.

Detailed Description
-----------------
The investigators designed a prospective randomized controlled trial where doctors from several randomly selected hospitals will use either a desktop PC or mobile (iPad) data collection tool. A validated user experience evaluation instrument will be used at the beginning, during interim analysis and at the end of the trial. The desktop-based data collection is built on Drupal, a renowned open source content management system (CMS). The same CMS will be used with a special interface designed for iOS/iPad. Both data collection platforms will be used in parallel to a prospective clinical trial.

Official Title
-----------------
Desktop vs. Mobile Data Collection in a Prospective Multicenter Clinical Trial

Conditions
-----------------
User Experience

Intervention / Treatment
-----------------
* Other: Evaluation form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency Room doctors Surgeons Agree to participate in the trial Provide informed consent Have basic information technology literacy Agree to receive brief training of the platform Exclusion Criteria: Clinicians and health care professionals not part of this trial Lacking of basic information technology literacy

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Desktop PC<br>Conventional institutional Desktop Personal Computers will be used to collect data of patients via a password protected encrypted interface. | Other: Evaluation form<br>* A validated user experience evaluation questionnaire will be completed by each participant in the beginning, at the interim period, and at the end of the trial<br>* Other names: User experience form;|
| Experimental: Mobile<br>Novel Mobile Clinical Trial Management System on iPads will be used to collect data of patients via a password protected encrypted interface. | Other: Evaluation form<br>* A validated user experience evaluation questionnaire will be completed by each participant in the beginning, at the interim period, and at the end of the trial<br>* Other names: User experience form;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation score | A validated user experience and evaluation instrument will be used. The overall score will be compared between the Desktop PC and Mobile (iPad) data collection tools. PC: indicates Personal Computer | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | The recruitment rate is defined as the proportion of patients recruited divided by the total number of patients recruited + patients missed: (rate=recruited/(recruited+missed). The recruitment rates will be compared between the Desktop PC and Mobile (iPad) data collection tools. PC: indicates Personal Computer | 2 years | 
| Cost-effectiveness analysis | Cost-effectiveness analysis (CEA) is a form of economic analysis that compares the relative costs and outcomes (effects) of two or more courses of action. CEA assigns a monetary value to the measure of effect. Typically the CEA is expressed in terms of a ratio where the denominator is a gain from a measure and the numerator is the cost associated with this gain. In this study, CEA will be calculated as: (ratio=costs/evaluation score) and (ratio=costs/recruitment rate). | 2 years | 
| Cost-benefit analysis | Cost-benefit analysis (CBA) is a systematic process for calculating and comparing benefits and costs of a project for two purposes; in order to determine if it is a sound investment (justification/feasibility), and to see how it compares with alternate projects (ranking/priority assignment). It involves comparing the total expected cost of each option against the total expected benefits, to see whether the benefits outweigh the costs, and by how much. In CBA, benefits and costs are expressed in money terms, and are adjusted for the time value of money. | 2 years | 
| Cost-utility analysis | Cost-utility analysis (CUA) is a form of financial analysis used to guide procurement decisions. The most common and well-known application of this analysis is in health technology assessment. Cost is measured in monetary units. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Desktop computer, Mobile, iPad, Evaluation, User experience, Benefits, Cost analysis