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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27044367