Protocol for 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)

Willie Hamilton; Luke Mounce; Gary A Abel; Sarah Gerard Dean; John L Campbell; Fiona C Warren; Anne Spencer; Antonieta Medina-Lara; Martin Pitt; Elizabeth Shephard; Marijke Shakespeare; Emily Fletcher; Adrian Mercer; Raff Calitri

doi:10.1136/bmjopen-2022-065232

Protocol for 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)

BMJ Open. 2023 Mar 20;13(3):e065232. doi: 10.1136/bmjopen-2022-065232.

Authors

Affiliations

¹ Primary Care Diagnostics, University of Exeter, EXETER, GB, UK W.Hamilton@exeter.ac.uk.
² Institute of Health Research, University of Exeter, Exeter, UK.
³ University of Exeter Medical School (Primary Care), University of Exeter, Exeter, Essex, UK.
⁴ PenCLAHRC University of Exeter Medical School, Exeter, UK.
⁵ Primary Care, University of Exeter, Exeter, UK.
⁶ Institute of Health Research, University of Exeter Medical School, Exeter, UK.
⁷ Health Economics, University of Exeter Medical School, Exeter, UK.
⁸ Health Economics Group, University of Exeter Medical School, Exeter, UK.
⁹ University of Exeter: Medical School, University of Exeter, Exeter, Essex, UK.
¹⁰ University of Exeter, Exeter, UK.
¹¹ Primary Care, University of Exeter Medical School, Exeter, UK.
¹² Primary Care Research Group, University of Exeter Medical School, Exeter, Devon, UK.

Abstract

Introduction: The UK has worse cancer outcomes than most comparable countries, with a large contribution attributed to diagnostic delay. Electronic risk assessment tools (eRATs) have been developed to identify primary care patients with a ≥2% risk of cancer using features recorded in the electronic record.

Methods and analysis: This is a pragmatic cluster randomised controlled trial in English primary care. Individual general practices will be randomised in a 1:1 ratio to intervention (provision of eRATs for six common cancer sites) or to usual care. The primary outcome is cancer stage at diagnosis, dichotomised to stage 1 or 2 (early) or stage 3 or 4 (advanced) for these six cancers, assessed from National Cancer Registry data. Secondary outcomes include stage at diagnosis for a further six cancers without eRATs, use of urgent referral cancer pathways, total practice cancer diagnoses, routes to cancer diagnosis and 30-day and 1-year cancer survival. Economic and process evaluations will be performed along with service delivery modelling. The primary analysis explores the proportion of patients with early-stage cancer at diagnosis. The sample size calculation used an OR of 0.8 for a cancer being diagnosed at an advanced stage in the intervention arm compared with the control arm, equating to an absolute reduction of 4.8% as an incidence-weighted figure across the six cancers. This requires 530 practices overall, with the intervention active from April 2022 for 2 years.

Ethics and dissemination: The trial has approval from London City and East Research Ethics Committee, reference number 19/LO/0615; protocol version 5.0, 9 May 2022. It is sponsored by the University of Exeter. Dissemination will be by journal publication, conferences, use of appropriate social media and direct sharing with cancer policymakers.

Trial registration number: ISRCTN22560297.

Keywords: Clinical trials; HEALTH SERVICES ADMINISTRATION & MANAGEMENT; PRIMARY CARE; Risk management.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Cost-Benefit Analysis
Delayed Diagnosis
General Practice*
Humans
Neoplasms* / diagnosis
Neoplasms* / therapy
Randomized Controlled Trials as Topic
Risk Assessment
Treatment Outcome

Associated data

ISRCTN/ISRCTN22560297

Grants and funding

C8640/A23385/CRUK_/Cancer Research UK/United Kingdom