Cargando…

A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol

BACKGROUND: Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety...

Descripción completa

Detalles Bibliográficos
Autores principales: Mastellos, Nikolaos, Andreasson, Anna, Huckvale, Kit, Larsen, Mark, Curcin, Vasa, Car, Josip, Agreus, Lars, Delaney, Brendan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4318251/
https://www.ncbi.nlm.nih.gov/pubmed/25648301
http://dx.doi.org/10.1186/s13012-015-0207-3
_version_ 1782355828667318272
author Mastellos, Nikolaos
Andreasson, Anna
Huckvale, Kit
Larsen, Mark
Curcin, Vasa
Car, Josip
Agreus, Lars
Delaney, Brendan
author_facet Mastellos, Nikolaos
Andreasson, Anna
Huckvale, Kit
Larsen, Mark
Curcin, Vasa
Car, Josip
Agreus, Lars
Delaney, Brendan
author_sort Mastellos, Nikolaos
collection PubMed
description BACKGROUND: Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials. METHODS/DESIGN: This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience. DISCUSSION: The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015. TRIAL REGISTRATION: EudraCT: 2014-001314-25
format Online
Article
Text
id pubmed-4318251
institution National Center for Biotechnology Information
language English
publishDate 2015
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-43182512015-02-06 A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol Mastellos, Nikolaos Andreasson, Anna Huckvale, Kit Larsen, Mark Curcin, Vasa Car, Josip Agreus, Lars Delaney, Brendan Implement Sci Study Protocol BACKGROUND: Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials. METHODS/DESIGN: This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience. DISCUSSION: The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015. TRIAL REGISTRATION: EudraCT: 2014-001314-25 BioMed Central 2015-02-03 /pmc/articles/PMC4318251/ /pubmed/25648301 http://dx.doi.org/10.1186/s13012-015-0207-3 Text en © Mastellos et al.; licensee BioMed Central. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Mastellos, Nikolaos
Andreasson, Anna
Huckvale, Kit
Larsen, Mark
Curcin, Vasa
Car, Josip
Agreus, Lars
Delaney, Brendan
A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol
title A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol
title_full A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol
title_fullStr A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol
title_full_unstemmed A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol
title_short A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol
title_sort cluster randomised controlled trial evaluating the effectiveness of ehealth-supported patient recruitment in primary care research: the transform study protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4318251/
https://www.ncbi.nlm.nih.gov/pubmed/25648301
http://dx.doi.org/10.1186/s13012-015-0207-3
work_keys_str_mv AT mastellosnikolaos aclusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT andreassonanna aclusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT huckvalekit aclusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT larsenmark aclusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT curcinvasa aclusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT carjosip aclusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT agreuslars aclusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT delaneybrendan aclusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT mastellosnikolaos clusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT andreassonanna clusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT huckvalekit clusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT larsenmark clusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT curcinvasa clusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT carjosip clusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT agreuslars clusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol
AT delaneybrendan clusterrandomisedcontrolledtrialevaluatingtheeffectivenessofehealthsupportedpatientrecruitmentinprimarycareresearchthetransformstudyprotocol