Clinical trial NCT01473238: Desktop Versus Mobile Data Collection in Clinical Trial
Official title: Desktop vs. Mobile Data Collection in a Prospective Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: User Experience
Keywords: Desktop computer
Mobile
iPad
Evaluation
User experience
Benefits
Cost analysis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Evaluation score
timeFrame: 2 years
Secondary outcomes:
measure: Recruitment rate
timeFrame: 2 years
measure: Cost-effectiveness analysis
timeFrame: 2 years
measure: Cost-benefit analysis
timeFrame: 2 years
measure: Cost-utility analysis
timeFrame: 2 years
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: University of St. Gallen, Institute of Information Managemen
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Surgery
Study officials:
affiliation: University Hospital Zurich, Department of Surgery
name: Dimitri A Raptis, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Zurich, Department of Surgical Research
name: Rolf Graf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Mirani R, Lederer A. An Instrument for Assessing the Organizational Benefits of IS projects. Decision Sciences, Vol. 29, No. 4, 1998, 803-838.