Condition category
Cancer
Date applied
08/03/2019
Date assigned
19/03/2019
Last edited
05/04/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Scientific

Primary contact

Prof Willie Hamilton

ORCID ID

http://orcid.org/0000-0003-1611-1373

Contact details

College House
University of Exeter Medical School
Heavitree Road
Exeter
EX1 2LU
United Kingdom
01392 726097
W.Hamilton@exeter.ac.uk

Type

Public

Additional contact

Dr Raff Calitri

ORCID ID

http://orcid.org/0000-0003-0889-4670

Contact details

Exeter Clinical Trials Unit
College House
University of Exeter Medical School
Heavitree Road
Exeter
EX1 2LU
United Kingdom
01392 726047
r.calitri@exeter.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1819/19

Study information

Scientific title

A pragmatic cluster randomised controlled trial of electronic risk-assessment for cancer to help identify early stage cancer in patients in general practice (The ERICA trial)

Acronym

ERICA

Study hypothesis

The overarching aim of the trial is to assess the clinical effectiveness and cost effectiveness of electronic Risk Assessment Tools (eRATs) for cancer compared to usual care for patients in general practice. The specific objectives of this study are to compare the effects of eRATs (vs usual care) on: cancer staging at time of diagnosis, cost to the NHS, patient experience of care, and service delivery.

Ethics approval

not provided at time of application

Submitted to: London – City and East REC (Henry VIII Committee Room, St Bartholomew's Hospital, North Wing, EC1A 7BE; 0207 1048033; nrescommittee.london-cityandeast@nhs.net), ref:

Study design

Pragmatic cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

Not available.

Condition

Cancer

Intervention

The eRATs are electronic clinical decision support tools embedded into the general practices’ principal clinical system. They work by collating relevant Read-coded symptoms, supplemented by existing routine blood tests already in the GP’s clinical system, which are then assessed for the possibility of cancer using published algorithms developed by Hamilton and colleagues. There are six eRATs of interest to the study (lung, colorectal, oesophago-gastric, bladder, kidney, and ovary) and they are housed within a Macmillan-sponsored Clinical Decision Support Tool. The eRATs have two main ways of working. Firstly, a prompt appears on screen when a patient has a risk of any one of the studied cancers of 2% or higher. Secondly, the clinician may specifically open a ‘symptom checker’ which lists the relevant symptoms of each studied cancer, allowing the patient’s symptoms to be added and the risk of cancer to be (re)calculated.

530 general practices will be randomised 1:1 to receive either the intervention (access to the suite of electronic Risk Assessment Tools; eRATs) or usual practice. The clusters will be practices. There will also be embedded process and health economics evaluations along with a parallel study modelling the impact of eRATs on NHS service delivery.

Randomisation
This is a pragmatic, cluster RCT. The 530 practices will be randomised using a 1:1 ratio into one of two trial arms: usual diagnostic practice (control) and usual diagnostic practice plus access to the suite of Macmillan electronic risk assessment tools (eRATs) (as the intervention), for a total of 265 practices per arm. Randomisation will be remote and web-based, conducted by an independent member of the data team at the Exeter Clinical Trials Unit, overseen by the CTU statistician (not the trial statistician). The sequence of randomisation will be computer generated. To ensure there is balance between the trial arms regarding practices’ propensity to refer patients for cancer investigation, we will minimise the randomisation by two week wait referral rate (the best available proxy) in national tertiles. We will use simple randomisation to allocate the first 50 practices (~10% of the total target), and then apply minimisation by two week wait referral rate, taking into account the previous allocations to inform the minimisation algorithm. To promote allocation concealment, all allocations using the minimisation algorithm will retain a stochastic element.
Once the member of the CTU data team has performed the randomisation, they will alert the trial manager (via email or phone call) who will in turn inform the practice of their allocation outcome. Although this randomisation with minimisation approach should make it almost impossible for the study team to predict the trial arm allocation for practices being processed (i.e., interested and undergoing screening), to ensure allocation concealment the last ten practices to be recruited will be randomised simultaneously – i.e., we will delay randomisation until we have ten final practices signed up to the study.

Data collection procedures
All primary and secondary outcome measures will be available from the cancer registry: applications for data release will be made to NCRAS. Public Health England (NCRAS) have, in principle, assigned us an in-house statistician to support the data collection process. We will be guided by NCRAS but anticipate requesting two data exports. Currently, there is approximately a 12 month time lag in availability of some of the outcome data we require. As a result, our first export will occur at the end of the trial data collection period. Our second export will occur 12 months after that. Data will not contain any personally identifiable information; we will be requesting and collecting depersonalised (pseudo-anonymised) data. The Public Health England Office for Data Release (ODR) guidelines indicate that no legal gateway (e.g., section 251 approval) will be necessary to obtain these data. For each export, data will be securely transferred in accordance with the registry’s policies and placed into a database developed by Exeter CTU situated on secure computer servers. The CTU will ensure the appropriate security measures are in place to comply with ODR and other required regulatory policies.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

Proportion of the combined six cancers diagnosed during 2-year follow-up that were at Stage 1/2 (early – cure likely) at diagnosis versus Stage 3/4 (late – cure not likely).

Secondary outcome measures

1. The stage at diagnosis of a further six cancers without eRATs will be explored and compared in intervention vs. control practices. This is to investigate the possibility of a ‘spill-over’ effect whereby eRATs are associated with increased diagnostic activity beyond the eRAT cancers.
2. Operational measures:
2.1 The practice’s number of patients diagnosed with the six eRAT cancers combined, and the total number of cases (excluding non-melanoma skin cancer).
2.2 Number of patients investigated or referred under the two-week wait system or equivalent for the six eRAT cancers combined, and in total (using waiting times data).
3. Proportion of patients diagnosed with cancer who were diagnosed via each route to diagnosis (this can be identified by Routes to Diagnosis Dataset, which uses HES data. Specifically, we will investigate the proportion diagnosed via the following routes: emergency attendance, two-week wait referral, GP referral, and “other”. We will collect this information for each of the six eRAT cancers, and for the six comparator non-eRAT cancers.
4. Two-week wait performance measures (using waiting times data), for the six eRAT cancer combined (restricting the sample to patients from relevant pathways) and for all cancer referrals:
4.1 “Conversion rate” – the proportion of patients from each practice referred under a two-week wait pathway who received a cancer diagnosis.
4.2 Target success – the proportion of patients from each practice referred under a relevant two week wait pathway for whom the target of being seen within two weeks was met. Additionally, we will explore the actual waiting time for these patients.
5. Survival measures: 30-day; 1-year (these two can be identified from patient records of the cancer registry dataset). 5-year survival will also be measured, but the main trial will report on 30 day and 1-year, with 5-year data being a subsidiary report.
6. Imaging investigations: the number of patients from each practice receiving colonoscopies, sigmoidoscopies, upper gastro-intestinal endoscopies, chest x-rays, abdominal ultrasounds, and abdominal CT scans. These measures will enable us to estimate any change in the expected number of adverse events from investigations that may arise from eRAT usage.
7. Adverse events: These are expected to be few, and largely related to complications from hospital investigation such as colonoscopy. There is no mechanism for these to be collected using routine data.

Overall trial start date

17/09/2018

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

We will not recruit participants to this RCT. It is a cluster RCT with the clusters being GP practices across England.
1. Practices must host either Microtest, SystmOne, or Vision principal clinical systems. Only practices completing an agreement to engage with the research processes and the intervention/control arms will be eligible; in a practice agreement the practice will confirm that a practice meeting has taken place and at least fifty per cent of their GPs have agreed to participate in the trial.

Participant type

Other

Age group

Other

Gender

Both

Target number of participants

530 General Practices

Participant exclusion criteria

1. If a practice is planning to merge or restructure over the course of the trial (to the extent that the practice size will change by at least 10%) they will not be permitted to participate

Recruitment start date

01/06/2019

Recruitment end date

31/03/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Exeter
University of Exeter Medical School Heavitree Road
Exeter
EX1 2LU
United Kingdom

Sponsor information

Organisation

University of Exeter

Sponsor details

Research Ethics and Governance Office
University of Exeter
Lafrowda House
St Germans Road
Exeter
EX4 6TL
United Kingdom
Lafrowda House, St Germans Road
p.r.baxter2@exeter.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

The Dennis and Mireille Gillings Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Exeter

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Trial progress will be reported to our PPI group at meetings and through quarterly newsletters. At the end of the study we will seek input from our PPI group to help disseminate a lay summary of the findings. We envisage a number of key papers arising from this pilot trial. A trial publication policy will be developed which outlines the strategic plan for dissemination. The results of the trial will be reported first to study collaborators, the TSC, and the funder. The main report will be drafted by the study team and circulated to all collaborators, The TMG and the TSC for comment. Key outputs from the trial will be presentations at national and international conferences, seminars, PPI events and dissemination through internationally recognised peer-reviewed journal publications (including open access web sources), newsletters and media releases.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available as it will contravene cancer registry policies.

Intention to publish date

01/10/2023

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/04/2019: Internal review. 29/03/2019: Internal review. 22/03/2019: Internal review. 19/03/2019: Trial’s existence confirmed by funder.