Testing an electronic safety netting system to help GPs follow up patients with worrying symptoms

ISRCTN	ISRCTN15913081
DOI	https://doi.org/10.1186/ISRCTN15913081
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	269169
Protocol serial number	CPMS 42868, IRAS 269169
Sponsor	University of Oxford
Funder	Cancer Research UK; Grant Codes: C48270/A27880

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Susannah Fleming
Public

Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Oxford
OX2 6GG
United Kingdom

Phone	+44 (0)1865 2-89220
Email	susannah.fleming@phc.ox.ac.uk

Prof Clare Bankhead
Scientific

Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Oxford
OX2 6GG
United Kingdom

Phone	+44 (0)1865 289351
Email	clare.bankhead@phc.ox.ac.uk

Study information

Primary study design	Interventional
Study design	Randomized; Interventional; Design type: Process of Care, Other
Secondary study design	Cluster randomised trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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
Completion date	31/10/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centres

NIHR CRN: Eastern

-
NR1 1QQ
United Kingdom

NIHR CRN: Greater Manchester

M13 9WL
United Kingdom

NIHR CRN: Kent, Surrey and Sussex

ME8 0NZ
United Kingdom

NIHR CRN: North East and North Cumbria

NE3 3HD
United Kingdom

NIHR CRN: North West Coast

L7 8XP
United Kingdom

NIHR CRN: North West London

W12 0HT
United Kingdom

NIHR CRN: South London

SE1 9RT
United Kingdom

NIHR CRN: South West Peninsula

PL6 8BX
United Kingdom

NIHR CRN: Thames Valley and South Midlands

OX3 9DU
United Kingdom

NIHR CRN: Wessex

SO30 2UN
United Kingdom

NIHR CRN: West Midlands

CV3 2TX
United Kingdom

NIHR CRN: West of England

BS1 2NT
United Kingdom

NIHR CRN: Yorkshire and Humber

S10 2SB
United Kingdom

University of Oxford

Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Oxford
OX2 6GG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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
Basic results			30/12/2024	No	No
HRA research summary			28/06/2023	No	No
Interim results article		22/07/2022	14/11/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			08/01/2025	No	Yes
Protocol file	version V1.6	30/06/2020	25/08/2020	No	No
Statistical Analysis Plan	version 1.0	16/07/2024	14/11/2024	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN15913081_PROTOCOL_V1.6_30Jun20.pdf: Uploaded 25/08/2020
ISRCTN15913081_SAP_V1.0.pdf: Statistical Analysis Plan
ISRCTN15913081_BasicResults.pdf: Basic results
ISRCTN15913081_Lay summary results.pdf: Plain English results

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.