Evaluation of a computer aid for assessing stomach symptoms
ISRCTN | ISRCTN12595588 |
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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
Plain English summary of protocol
Contact information
Scientific
University of Durham
Evaluation, Research and Development Unit
University Boulevard
Thornaby
Stockton-on-Tees, Durham
TS17 6BH
United Kingdom
0000-0002-4967-0297 |
Study information
Study design | Randomised; Interventional and Observational; Design type: Screening, Qualitative |
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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 |
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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
DH1 5TS
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Sponsor information
University/education
Old Elvet
Durham
DH1 3HP
England
United Kingdom
https://ror.org/01v29qb04 |
Funders
Funder type
Government
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 | |
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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.