Testing an electronic safety netting system to help GPs follow up patients with worrying symptoms
| ISRCTN | ISRCTN15913081 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15913081 |
| IRAS number | 269169 |
| Secondary identifying numbers | CPMS 42868, IRAS 269169 |
- Submission date
- 04/11/2019
- Registration date
- 08/11/2019
- Last edited
- 08/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
GPs use a technique called safety-netting to ensure their patients come back to the surgery for a follow-up appointment. This is very important when patients have symptoms that could lead to an important diagnosis such as cancer. One way to safety-net could be for the GP practice to have a computer system that highlights abnormal test results or that identifies patients who have not attended for their appointments. This study is designed to evaluate a safety-netting system that is available in general practices in England, called the E-SN toolkit.
Who can participate?
General practices who are already members of the RCGP Research and Surveillance Centre research network can take part in the study. Practices need to be using the EMIS computer system, and have data available to the research network for the past 2 years. Patients within participating practices will have data extracted as part of the study if they are over 18 years old. The researchers won’t extract data from patients who have opted out of data sharing.
What does the study involve?
The researchers recruit 60 general practices who are not currently using the E-SN toolkit, and randomly allocated them in clusters (groups) of 10. Each cluster has the E-SN toolkit turned on at a different time during the 12 months of the study. Once the E-SN toolkit is turned on, the GPs in the practice are able to use it when caring for any patient they think would benefit from it, although it is expected that it will be of most use when treating patients with symptoms that might indicate cancer. The researchers collect data from the electronic patient record system from the 12 months of the study and the 24 months before the start of the study to understand whether the introduction of the E-SN toolkit makes any difference to the diagnosis of cancer, and in particular to how quickly patients are diagnosed. The researchers only extract records from patients who are over 18, and who have not opted out of the research.
What are the possible benefits and risks of participating?
Patients may benefit from better follow up if the E-SN toolkit is used, and it is hoped that this will lead to a short time to diagnosis. If a patient with cancer has an earlier diagnosis, they may have a better chance of successful treatment. The risk of this study is very low. Using the E-SN toolkit may make GP consultations a bit longer, but this is probably only going to be by less than a minute. There is a risk of patients losing trust in the health system by becoming aware that their data is being used for research without them being asked for their consent. The researchers are hoping to reduce this by making sure that patients are aware of the study, and that they will not be identifiable from the data. They are also making sure that patients can easily opt out of sharing their data.
Where is the study run from?
The researchers carrying out the study are based at the University of Oxford and they are working with an established research network: the RCGP Research and Surveillance Centre.
When is the study starting and how long is it expected to run for?
June 2019 to October 2021
Who is funding the study?
Cancer Research UK
Who is the main contact?
Dr Susannah Fleming
susannah.fleming@phc.ox.ac.uk
Contact information
Public
Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Oxford
OX2 6GG
United Kingdom
| Phone | +44 (0)1865 2-89220 |
|---|---|
| susannah.fleming@phc.ox.ac.uk |
Scientific
Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Oxford
OX2 6GG
United Kingdom
| Phone | +44 (0)1865 289351 |
|---|---|
| clare.bankhead@phc.ox.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Process of Care, Other |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | CASNET2: Evaluation of an e-safety netting cancer template in primary care: a pragmatic stepped-wedge RCT |
| Study acronym | CASNET2 |
| Study objectives | GPs use a technique called safety-netting to ensure their patients come back to the surgery for a follow-up appointment. This is very important when patients have symptoms that could lead to an important diagnosis such as cancer. One way to safety-net could be for the GP practice to have a computer system that highlights abnormal test results or that identifies patients who have not attended for their appointments. This study is designed to evaluate a safety-netting system that is available in general practices in England, called the E-SN toolkit. |
| Ethics approval(s) | Approved 05/12/2019, North West - Greater Manchester West Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8021; nrescommittee.northwest-gmwest@nhs.net), ref: 19/NW/0692 |
| Health condition(s) or problem(s) studied | E-safety netting (E-SN) toolkit |
| Intervention | The researchers will recruit 60 general practices who are not currently using the E-SN toolkit, and randomise them in clusters (groups) of 10. Each cluster will have the E-SN toolkit turned on at a different time during the 12 months of the study. Once the E-SN toolkit is turned on, the GPs in the practice will be able to use it when caring for any patient they think would benefit from it, although it is expected that it will be of most use when treating patients with symptoms that might indicate cancer. The researchers will collect data from the electronic patient record system from the 12 months of the study and the 24 months before the start of the study to understand whether the introduction of the E-SN toolkit makes any difference to the diagnosis of cancer, and in particular to how quickly patients are diagnosed. The researchers will only extract records from patients who are over 18, and who have not opted out of the research. |
| Intervention type | Other |
| Primary outcome measure | Primary care interval for cancer diagnoses measured as the time between the first recorded symptom of cancer and referral to secondary cancer care, during inactive and active E-SN phases |
| Secondary outcome measures | 1. Proportion of cancers diagnosed after emergency presentation measured during inactive and active E-SN phases 2. Recorded new diagnoses in those who have a template activated, measured by cancer site and stage, and by non-cancer diagnosis, during the active E-SN stage 3. Total time to diagnosis measured from 1st recorded symptom to definitive diagnosis for all cancer diagnoses during the inactive and active E-SN phases and all diagnoses with template activation during the active E-SN phase 4. Number of GP consultations/patient between first record of symptom and cancer referral, measured during the inactive and active E-SN phase 5. Rates of patients completing direct access cancer investigations measured during the inactive and active E-SN phase 6. Rates of patients referred measured as 2-week wait, urgent, and routine, during the inactive and active E-SN phase 7. Timing of template activation within the primary care interval (from first symptom to referral) measured during the active E-SN phase 8. Template activation rate amongst consulting patients, both total and stratified by individual GP, measured during the active E-SN phase 9. The proportion of diary entries completed measured during the active E-SN phase 10. The reason for template activation measured based on 20 high-level READ codes during the active E-SN phase 11. Symptoms leading to direct access to investigations measured during the active E-SN phase 12. Recorded vague symptoms in the template measured during the active E-SN phase 13. Demographic details of patients with activated templates measured during the active E-SN phase 14. GP type completing template (e.g. partner, locum, trainee) measured during the active E-SN phase 15. Diagnostic codes in patients with activated templates measured during the active E-SN phase |
| Overall study start date | 01/06/2019 |
| Completion date | 31/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Total final enrolment | 54 |
| Key inclusion criteria | GP practices will be eligible for inclusion under the following conditions: 1. They are actively contributing to the RCGP Research and Surveillance Centre database 2. They use the EMIS electronic health record system 3. They have data available for the previous 24 months Within the participating practices, the researchers will seek to extract data from adult patients (aged over 18 years) |
| Key exclusion criteria | 1. GP practices who are already using the E-SN toolkit will not be eligible for the study 2. The researchers will not extract data from any patient under 18, or from any patient who has opted out of data sharing for research purposes |
| Date of first enrolment | 25/11/2019 |
| Date of final enrolment | 19/08/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
NR1 1QQ
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Radcliffe Observatory Quarter
Oxford
OX2 6GG
United Kingdom
Sponsor information
University/education
Clinical Trials and Research Governance
Joint Research Office
1st floor, Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7LQ
England
United Kingdom
| ctrg@admin.ox.ac.uk | |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
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 | 31/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Peer-reviewed scientific journals 2. Internal report 3. Conference presentation 4. Publication on website 5. Results will be published on the University of Oxford and RCGP RSC websites, and in the RCGP RSC newsletter |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to agreements regarding data security of potentially sensitive patient data, to ensure compliance with relevant data protection law and best practice. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 24/08/2020 | 25/08/2020 | Yes | No |
| Protocol file | version V1.6 | 30/06/2020 | 25/08/2020 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Interim results article | 22/07/2022 | 14/11/2024 | Yes | No | |
| Statistical Analysis Plan | version 1.0 | 16/07/2024 | 14/11/2024 | No | No |
| Basic results | 30/12/2024 | No | No | ||
| Plain English results | 08/01/2025 | No | Yes |
Additional files
Editorial Notes
08/01/2025: Lay summary results were uploaded.
30/12/2024: Basic results uploaded and the intention to publish date was changed from 31/01/2025 to 31/07/2025.
14/11/2024: Publication reference and statistical analysis plan added.
08/07/2024: The intention to publish date was changed from 30/06/2024 to 31/01/2025.
13/12/2023: The intention to publish date was changed from 31/12/2023 to 30/06/2024.
07/12/2022: The intention to publish date was changed from 31/12/2022 to 31/12/2023.
03/05/2022: The intention to publish date was changed from 31/03/2022 to 31/12/2022.
26/08/2021: The following changes have been made:
1. The recruitment end date has been changed from 16/08/2021 to 19/08/2021.
2. The total final enrolment number has been added.
25/08/2020: Trial website and publication reference added. Uploaded protocol Version 1.6, 30 June 2020 (not peer reviewed).
11/08/2020: The following changes were made to the trial record:
1. Recruitment to this study is no longer paused.
2. The recruitment end date was changed from 01/08/2020 to 16/08/2021.
3. The overall trial end date was changed from 10/03/2021 to 31/10/2021.
4. The intention to publish date was changed from 31/12/2021 to 31/03/2022.
27/07/2020: The ethics approval was added.
20/04/2020: Due to current public health guidance, recruitment for this study has been paused.
15/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 01/08/2020.
2. The overall trial end date has been changed from 31/12/2020 to 10/03/2021.
08/11/2019: Trial's existence confirmed by the NIHR.
