Evaluation of a computer aid for assessing stomach symptoms

ISRCTN	ISRCTN12595588
DOI	https://doi.org/10.1186/ISRCTN12595588
Secondary identifying numbers	18331

Submission date: 10/06/2015
Registration date: 10/06/2015
Last edited: 06/12/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-a-computer-aid-to-help-gps-decide-who-needs-further-tests-for-stomach-symptoms

Contact information

Prof Greg P. Rubin
Scientific

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

ORCID ID	0000-0002-4967-0297

Study information

Study design	Randomised; Interventional and Observational; Design type: Screening, Qualitative
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
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
Study acronym	ECASS
Study objectives	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(s)	14/NE/1179
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2014
Completion date	28/05/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 3030; UK Sample Size: 3030
Total final enrolment	530
Key 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
Key exclusion criteria	1. Inability to understand study documentation, for instance because of a lack of English fluency 2. Patients unable to provide informed consent
Date of first enrolment	01/06/2015
Date of final enrolment	28/05/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

NHS North Durham CCG

Durham
DH1 5TS
United Kingdom

NHS Durham Dales, Easington & Sedgefield CCG

TS21 3EE
United Kingdom

NHS Darlington CCG

DL3 6JL
United Kingdom

NHS Hartlepool & Stockton on Tees CCG

TS23 2LA
United Kingdom

NHS South Tees CCG

TS3 6AL
United Kingdom

NHS Cambridgeshire and Peterborough CCG

CB2 8FH
United Kingdom

NHS Bedfordshire CCG

MK45 4HR
United Kingdom

Sponsor information

University of Durham (UK)
University/education

Old Elvet
Durham
DH1 3HP
England
United Kingdom

"ROR"	https://ror.org/01v29qb04

Funders

Funder type

Government

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	04/04/2016		Yes	No
Results article		18/03/2021	10/05/2021	Yes	No
Plain English results			06/12/2022	No	Yes
HRA research summary			28/06/2023	No	No

Editorial Notes

06/12/2022: Link to CRUK plain English results added.
10/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
11/01/2019: No publications found, verifying study status with principal investigator.
22/04/2016: Plain English summary link added.
06/04/2016: Publication reference added.