Condition category
Not Applicable
Date applied
04/11/2019
Date assigned
08/11/2019
Last edited
08/11/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 December 2020

Who is funding the study?
Cancer Research UK

Who is the main contact?
Dr Susannah Fleming
susannah.fleming@phc.ox.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Susannah Fleming

ORCID ID

Contact details

Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Oxford
OX2 6GG
United Kingdom
+44 (0)1865 2-89220
susannah.fleming@phc.ox.ac.uk

Type

Scientific

Additional contact

Prof Clare Bankhead

ORCID ID

Contact details

Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Oxford
OX2 6GG
United Kingdom
+44 (0)1865 289351
clare.bankhead@phc.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS: 42868

Study information

Scientific title

CASNET2: Evaluation of an e-safety netting cancer template in primary care: a pragmatic stepped-wedge RCT

Acronym

CASNET2

Study hypothesis

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

Approval pending, North West - Greater Manchester West Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; Tel: +44 (0)207 104 8021; Email: nrescommittee.northwest-gmwest@nhs.net), ref: 19/NW/0692

Study design

Randomised; Interventional; Design type: Process of Care, Other

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

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 trial start date

01/06/2019

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant 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

Recruitment start date

25/11/2019

Recruitment end date

31/12/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NIHR CRN: Eastern

-
NR1 1QQ
United Kingdom

Trial participating centre

NIHR CRN: Greater Manchester
M13 9WL
United Kingdom

Trial participating centre

NIHR CRN: Kent, Surrey and Sussex
ME8 0NZ
United Kingdom

Trial participating centre

NIHR CRN: North East and North Cumbria
NE3 3HD
United Kingdom

Trial participating centre

NIHR CRN: North West Coast
L7 8XP
United Kingdom

Trial participating centre

NIHR CRN: North West London
W12 0HT
United Kingdom

Trial participating centre

NIHR CRN: South London
SE1 9RT
United Kingdom

Trial participating centre

NIHR CRN: South West Peninsula
PL6 8BX
United Kingdom

Trial participating centre

NIHR CRN: Thames Valley and South Midlands
OX3 9DU
United Kingdom

Trial participating centre

NIHR CRN: Wessex
SO30 2UN
United Kingdom

Trial participating centre

NIHR CRN: West Midlands
CV3 2TX
United Kingdom

Trial participating centre

NIHR CRN: West of England
BS1 2NT
United Kingdom

Trial participating centre

NIHR CRN: Yorkshire and Humber
S10 2SB
United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Governance
Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7LQ
United Kingdom
-
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK; Grant Codes: C48270/A27880

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

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 statement
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.

Intention to publish date

31/12/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/11/2019: Trial's existence confirmed by the NIHR.