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 logoORCID ID 0000-0002-4967-0297

Study information

Study designRandomised; Interventional and Observational; Design type: Screening, Qualitative
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titlePhase 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 acronymECASS
Study objectivesThe 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) studiedTopic: Primary Care; Subtopic: Primary care; Disease: All Diseases
InterventionParticipants 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 typeOther
Primary outcome measureFeasibility; Timepoint(s): 6 months
Secondary outcome measuresAll 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 date01/10/2014
Completion date28/05/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 3030; UK Sample Size: 3030
Total final enrolment530
Key inclusion criteria1. 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 criteria1. Inability to understand study documentation, for instance because of a lack of English fluency
2. Patients unable to provide informed consent
Date of first enrolment01/06/2015
Date of final enrolment28/05/2017

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 logo "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 shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planWe 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 planNot 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.