Condition category
Cancer
Date applied
10/06/2015
Date assigned
10/06/2015
Last edited
22/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Prof Greg P. Rubin

ORCID ID

http://orcid.org/0000-0002-4967-0297

Contact details

University of Durham
Evaluation
Research and Development Unit
University Boulevard
Thornaby
Stockton-on-Tees
Durham
TS17 6BH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18331

Study information

Scientific 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

Acronym

ECASS

Study hypothesis

The aim of this study is 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.

Ethics approval

14/NE/1179

Study design

Randomised; Interventional and Observational; Design type: Screening, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Primary Care; Subtopic: Primary care; Disease: All Diseases

Intervention

Participants are clustered (at the participating site level) to the intervention arm or usual care.

Practices randomised to the intervention arm will be provided with the oesophagogastric (OG) eRAT, which will be embedded into their clinical system. The eRAT provides a dropdown box containing an interactive risk calculator, which can be opened at the GP’s discretion during the consultation. It allows additional symptoms to be entered and generates a value for the risk of a currently undiagnosed OG cancer, together with guidance on whether or not to refer for further investigation.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Feasibility; Timepoint(s): 6 months

Secondary outcome measures

All measured at six months from patient recruitment, and will be taken from patient notes (primary and secondary care).

1. Practitioner outcomes: frequency and sustainability of use of eRAT, adherence to recommendations, attitudes to and role of eCDS.
2. Service outcomes: referral rates; use of diagnostic pathways (2WW and direct access gastroscopy, conversion (proportion of referrals with cancer diagnosis) and detection rates (proportion of OG cancers referred through these routes); Time from first consultation to diagnosis with cancer (diagnostic interval)
3. Health economic outcomes based on estimates of resource use
4. Patient outcomes: acceptability of use of eCDS

Overall trial start date

01/10/2014

Overall trial end date

28/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients presenting to the GP with symptoms associated with OG cancer (NICE clinical guidelines 17 & 27)
2. Aged 55 years and over
3. Target Gender: Male & Female
4. Aged 55-100

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 3030; UK Sample Size: 3030

Participant exclusion criteria

1. Inability to understand study documentation, for instance because of a lack of English fluency
2. Patients unable to provide informed consent

Recruitment start date

01/06/2015

Recruitment end date

28/05/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS North Durham CCG
Durham
DH1 5TS
United Kingdom

Trial participating centre

NHS Durham Dales, Easington & Sedgefield CCG
TS21 3EE
United Kingdom

Trial participating centre

NHS Darlington CCG
DL3 6JL
United Kingdom

Trial participating centre

NHS Hartlepool & Stockton on Tees CCG
TS23 2LA
United Kingdom

Trial participating centre

NHS South Tees CCG
TS3 6AL
United Kingdom

Trial participating centre

NHS Cambridgeshire and Peterborough CCG
CB2 8FH
United Kingdom

Trial participating centre

NHS Bedfordshire CCG
MK45 4HR
United Kingdom

Sponsor information

Organisation

University of Durham (UK)

Sponsor details

Old Elvet
Durham
DH1 3HP
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

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

We intend to report and disseminate the results of the study through peer reviewed scientific journals, internal reporting and newsletters, conference presentations and publications on our websites.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27044367

Publication citations

Additional files

Editorial Notes

22/04/2016: Plain English summary link added. 06/04/2016: Publication reference added.