Desktop Versus Mobile Data Collection in Clinical Trial

User Experience Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01473238
• Other study ID #: PSP_Appendix_2
• Status: Not yet recruiting
• Phase: N/A
• First received: November 14, 2011
• Last updated: August 22, 2013
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: August 2013
• Source: University of Zurich
• Contact: Dimitri A Raptis, MD, MSc
• Phone: +41798820542
• Email: dimitri.raptis[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• User Experience

Intervention

Other:
• Evaluation form
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

Locations

Country	Name	City	State
Switzerland	University of St. Gallen, Institute of Information Managemen	St. Gallen
Switzerland	University Hospital Zurich, Department of Surgery	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Mirani R, Lederer A. An Instrument for Assessing the Organizational Benefits of IS projects. Decision Sciences, Vol. 29, No. 4, 1998, 803-838.

Raptis DA, Fernandes C, Chua W, Boulos PB. Electronic software significantly improves quality of handover in a London teaching hospital. Health Informatics J. 2009 Sep;15(3):191-8. doi: 10.1177/1460458209337431. — View Citation

Raptis DA, Mettler T, Tzanas K, Graf R. A novel open-source web-based platform promoting collaboration of healthcare professionals and biostatisticians: a design science approach. Inform Health Soc Care. 2012 Jan;37(1):22-36. doi: 10.3109/17538157.2011.590257. Epub 2011 Oct 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   An Instrument for Assessing the Organizational Benefits of IS Projects
•   The official online, web-based, password-protected, and encrypted clinical trial management system to support this multicenter clinical trial data collection and trial management