Integrating technology into complex intervention trial processes: a case study

Drew, Cheney ORCID: https://orcid.org/0000-0002-4397-6252, Poile, Vincent, Trubey, Robert, Watson, Gareth, Kelson, Mark ORCID: https://orcid.org/0000-0001-7744-3780, Townson, Julia ORCID: https://orcid.org/0000-0001-8679-3619, Rosser, Anne Elizabeth ORCID: https://orcid.org/0000-0002-4716-4753, Hood, Kerenza ORCID: https://orcid.org/0000-0002-5268-8631, Quinn, Lori ORCID: https://orcid.org/0000-0002-2982-923X and Busse, Monica ORCID: https://orcid.org/0000-0002-5331-5909 2016. Integrating technology into complex intervention trial processes: a case study. Trials 17 (1) , 551. 10.1186/s13063-016-1674-9

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Abstract

Background Trials of complex interventions are associated with high costs and burdens in terms of paperwork, management, data collection, validation, and intervention fidelity assessment occurring across multiple sites. Traditional data collection methods rely on paper-based forms, where processing can be time-consuming and error rates high. Electronic source data collection can potentially address many of these inefficiencies, but has not routinely been used in complex intervention trials. Here we present the use of an on-line system for managing all aspects of data handling and for the monitoring of trial processes in a multicentre trial of a complex intervention. We custom built a web-accessible software application for the delivery of ENGAGE-HD, a multicentre trial of a complex physical therapy intervention. The software incorporated functionality for participant randomisation, data collection and assessment of intervention fidelity. It was accessible to multiple users with differing levels of access depending on required usage or to maintain blinding. Each site was supplied with a 4G-enabled iPad for accessing the system. The impact of this system was quantified through review of data quality and collation of feedback from site coordinators and assessors through structured process interviews. Results The custom-built system was an efficient tool for collecting data and managing trial processes. Although the set-up time required was significant, using the system resulted in an overall data completion rate of 98.5% with a data query rate of 0.1%, the majority of which were resolved in under a week. Feedback from research staff indicated that the system was highly acceptable for use in a research environment. This was a reflection of the portability and accessibility of the system when using the iPad and its usefulness in aiding accurate data collection, intervention fidelity and general administration. Conclusions A combination of commercially available hardware and a bespoke online database designed to support data collection, intervention fidelity and trial progress provides a viable option for streamlining trial processes in a multicentre complex intervention trial. There is scope to further extend the system to cater for larger trials and add further functionality such as automatic reporting facilities and participant management support.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Centre for Law and Religion (CLR) Medicine
Subjects:	K Law > K Law (General) T Technology > T Technology (General)
Uncontrolled Keywords:	Technology, Data collection, Complex intervention trials, Database design, Fidelity, Process evaluation
Publisher:	BioMed Central
ISSN:	1745-6215
Funders:	Health and Care Research Wales
Date of First Compliant Deposit:	11 November 2016
Date of Acceptance:	31 October 2016
Last Modified:	27 Jun 2024 01:12
URI:	https://orca.cardiff.ac.uk/id/eprint/96047

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