Protocol for a pragmatic cluster randomised controlled trial assessing the clinical effectiveness and cost effectiveness of electronic risk-assessment tools for cancer for patients in general practice (ERICA)

Conference: 
SAPC ASM 2019 - Exeter
Talk Code: 
P1.66
Presenter: 
Raff Calitri
Co-authors: 
Dr Luke Mounce, Dr Gary Abel, Prof John Campbell, Prof Anne Spencer, Dr Antonieta Medina-Lara, Dr Martin Pitt, Dr Elizabeth Shephard, Dr Fiona Warren, Prof Sarah Dean, Prof Willie Hamilton
Author institutions: 
University of Exeter

Problem

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.

Approach

A pragmatic cluster RCT with 710 practices across England and Wales randomised 1:1 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 embedded process and health economics evaluations along with a parallel study modelling the impact of eRATs on NHS service delivery. Clinical outcomes will be observed in routinely collected data exported from English and Welsh cancer registries. The primary outcome will be the proportion of the combined six cancers diagnosed during a 2-year follow-up that were at Stage 1/2 (early – cure likely) versus Stage 3/4 (late – cure not likely) at the time of diagnosis. Secondary outcomes include 30-day and 1-year survival. Ethics approval and trial registration will be sought in the early spring 2019. Practice recruitment is planned to launch in spring/summer 2019 and close in winter 2019.

Findings

Results of the RCT will be available from winter 2023.

Consequences

The results of the RCT will provide a definitive assessment of the clinical effectiveness and cost effectiveness of the six eRATs being studied, and report the acceptability of eRATs and their impact on care from the perspective of both GPs and patients.

Submitted by: 
Raff Calitri
Funding acknowledgement: 
Funding and support from: The Dennis and Mireille Gillings Foundation University of Exeter Cancer Research UK Health Care Research Wales & NIHR Clinicial Research Network Macmillan Cancer Support