Desktop Versus Mobile Data Collection in Clinical Trial
Desktop vs. Mobile Data Collection in a Prospective Multicenter Clinical Trial
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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St. Gallen, Schweiz, CH-9000
- University of St. Gallen, Institute of Information Managemen
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Zurich, Schweiz, CH-8091
- University Hospital Zurich, Department of Surgery
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Desktop PC
Conventional institutional Desktop Personal Computers will be used to collect data of patients via a password protected encrypted interface.
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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
Andre navne:
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Eksperimentel: Mobile
Novel Mobile Clinical Trial Management System on iPads will be used to collect data of patients via a password protected encrypted interface.
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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
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Evaluation score
Tidsramme: 2 years
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Recruitment rate
Tidsramme: 2 years
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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
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Cost-effectiveness analysis
Tidsramme: 2 years
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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
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Cost-benefit analysis
Tidsramme: 2 years
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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".
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2 years
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Cost-utility analysis
Tidsramme: 2 years
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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.
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2 years
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Dimitri A Raptis, MD, MSc, University Hospital Zurich, Department of Surgery
- Ledende efterforsker: Rolf Graf, PhD, University Hospital Zurich, Department of Surgical Research
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- Mirani R, Lederer A. An Instrument for Assessing the Organizational Benefits of IS projects. Decision Sciences, Vol. 29, No. 4, 1998, 803-838.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PSP_Appendix_2
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