ECASS - Evaluation of a Computer Aid for assessing Stomach Symptoms
Research type
Research Study
Full title
Phase II exploratory randomised controlled trial (RCT) comparing use of electronic clinical decision support (eCDS) for suspected oesophago-gastric cancer in primary care with usual care.
IRAS ID
155038
Contact name
Greg Rubin
Contact email
Sponsor organisation
Durham University
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Patients with oesophagogastric (OG) cancer often consult their GP a number of times before referral. Less than a third are referred to hospital using the urgent suspected cancer pathway and over a quarter are diagnosed following emergency admission. These cancers present with symptoms that, apart from dysphagia, are poorly predictive of cancer. Practices that investigate more patients have better outcomes. However, gastroscopy is an invasive procedure and has resource implications. Any increase in activity should target those patients most likely to benefit.
Aim
To test the effects of a computerised clinical decision support (eCDS) tool to assist GPs in selection of patients for gastroscopy for possible OG cancer, and to collect all the relevant data to inform a phase III trial of such a tool.
Methods
A multi-site Phase II cluster RCT of the electronic Risk Assessment Tool (eRAT) for OG cancer on the BMJ Informatica platform and embedded in practice clinical systems, compared to usual care. This mode of provision is currently being used in a feasibility pilot of eDCS led by Macmillan Cancer Support.
Participants will be patients aged 55 and over who present to their GP with upper gastrointestinal symptoms. Participants will be followed up for 6 months using primary and secondary care records. Outcome measures will include practitioner outcomes, service outcomes, length of the diagnostic interval, health economic outcomes and patient outcomes. These will inform our selection of outcome measures and power calculations for a subsequent Phase III trial.
We will undertake semi-structured interviews with GPs and patients to identify and gain an understanding of the acceptability and usefulness of the eCDS in clinical practice.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/1179
Date of REC Opinion
7 Nov 2014
REC opinion
Favourable Opinion