Electronic Risk Assessment for Cancer (ERICA)_Version 1
Research type
Research Study
Full title
A pragmatic cluster randomised controlled trial assessing the clinical effectiveness and cost effectiveness of electronic risk-assessment for cancer for patients in general practice (ERICA)
IRAS ID
255955
Contact name
Pam Baxter
Contact email
Sponsor organisation
University of Exeter
ISRCTN Number
ISRCTN22560297
Duration of Study in the UK
4 years, 2 months, 31 days
Research summary
Compared with other developed countries, the UK has poorer cancer outcomes. Early cancer diagnosis within general practice has the potential to facilitate improvements. Paper and mouse mat Risk Assessment Tools (RATs) for 18 cancers have been developed to support GPs in identifying cancer. The RATs give precise estimates of the risk of an underlying cancer based on a single symptom or combination of symptoms. RATs have increased cancer diagnostic activity. Some of the RATs have been converted into electronic versions (eRATs) and embedded into GPs’ clinical systems, delivering an automated prompt to consider the possibility of cancer when a patient has at least a 2% risk of cancer. Early pilot work suggests that the eRATs are acceptable to GPs. There is no evidence to date of their clinical effectiveness or cost effectiveness.
We have designed a trial to assess the clinical effectiveness and cost effectiveness of eRATs. This is a pragmatic cluster Randomised Controlled Trial (RCT) with 530 practices across England. Practices will be randomly allocated to receive either the intervention (access to a suite of eRATs including: lung, oesophago-gastric, kidney, bladder, ovarian, colorectal) or usual practice. There will also be an embedded process evaluation (to look at the impact of the eRATs on GP and patient consultation) and health economics evaluation along with a another nested study modelling the impact of eRATs on NHS service delivery.
Clinical outcomes will be observed in routinely collected data exported from the National Cancer Registry. The primary outcome is whether a patient diagnosed with one of the six cancers during the follow-up period is diagnosed at stage 1/2 (early – cure likely) or stage 3/4 (late – cure not likely). Secondary outcomes include route to diagnosis, 30-day, 1-year survival, and negative events arising from clinical imaging investigations (e.g., scopes to look into people's colon).
REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0615
Date of REC Opinion
13 May 2019
REC opinion
Favourable Opinion