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Evaluating a computer aid for assessing stomach symptoms (ECASS): study protocol for a randomised controlled trial

Overview of attention for article published in Trials, April 2016
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Title
Evaluating a computer aid for assessing stomach symptoms (ECASS): study protocol for a randomised controlled trial
Published in
Trials, April 2016
DOI 10.1186/s13063-016-1307-3
Pubmed ID
Authors

Helen J. Moore, Catherine Nixon, Anisah Tariq, Jon Emery, Willie Hamilton, Zoë Hoare, Anne Kershenbaum, Richard D. Neal, Obioha C. Ukoumunne, Juliet Usher-Smith, Fiona M. Walter, Sophie Whyte, Greg Rubin

Abstract

For most cancers, only a minority of patients have symptoms meeting the National Institute for Health and Clinical Excellence guidance for urgent referral. For gastro-oesophageal cancers, the 'alarm' symptoms of dysphagia and weight loss are reported by only 32 and 8 % of patients, respectively, and their presence correlates with advanced-stage disease. Electronic clinical decision-support tools that integrate with clinical computer systems have been developed for general practice, although uncertainty remains concerning their effectiveness. The objectives of this trial are to optimise the intervention and establish the acceptability of both the intervention and randomisation, confirm the suitability and selection of outcome measures, finalise the design for the phase III definitive trial, and obtain preliminary estimates of the intervention effect. This is a two-arm, multi-centre, cluster-randomised, controlled phase II trial design, which will extend over a 16-month period, across 60 general practices within the North East and North Cumbria and the Eastern Local Clinical Research Network areas. Practices will be randomised to receive either the intervention (the electronic clinical decision-support tool) or to act as a control (usual care). From these practices, we will recruit 3000 adults who meet the trial eligibility criteria and present to their GP with symptoms suggestive of gastro-oesophageal cancer. The main measures are the process data, which include the practitioner outcomes, service outcomes, diagnostic intervals, health economic outcomes, and patient outcomes. One-on-one interviews in a sub-sample of 30 patient-GP dyads will be undertaken to understand the impact of the use or non-use of the electronic clinical decision-support tool in the consultation. A further 10-15 GPs will be interviewed to identify and gain an understanding of the facilitators and constraints influencing implementation of the electronic clinical decision-support tool in practice. We aim to generate new knowledge on the process measures regarding the use of electronic clinical decision-support tools in primary care in general and to inform a subsequent definitive phase III trial. Preliminary data on the impact of the support tool on resource utilisation and health care costs will also be collected. ISRCTN Registry, ISRCTN12595588 .

Mendeley readers

The data shown below were compiled from readership statistics for 70 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United Kingdom 1 1%
Unknown 69 99%

Demographic breakdown

Readers by professional status Count As %
Researcher 14 20%
Student > Ph. D. Student 14 20%
Student > Master 12 17%
Other 8 11%
Unspecified 7 10%
Other 15 21%
Readers by discipline Count As %
Medicine and Dentistry 27 39%
Unspecified 13 19%
Nursing and Health Professions 8 11%
Psychology 6 9%
Agricultural and Biological Sciences 3 4%
Other 13 19%