Cancer Cancer
Conditions
Interventions
The eRATs are electronic clinical decision support tools embedded into the general practices’ principal clinical system. They work by collating relevant Read-coded symptoms, supplemented by existing r
eRATs) or usual practice. The clusters will be practices. There will also be embedded process and health economics evaluations along with a parallel study modelling the impact of eRATs on NHS servic
Sponsors
University of Exeter
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 23/01/2023: We will not recruit participants to the main RCT. It is a cluster RCT with the clusters being GP practices across England. Practices must host either EMIS, or SystmOne, principal clinical systems. Only practices completing an agreement to engage with the research processes and the intervention/control arms will be eligible; in a practice agreement the practice will confirm that a practice meeting has taken place and at least fifty per cent of their GPs have agreed to participate in the trial. Practices that are proposing a split or a merger are not eligible. We will also run a series of nested studies which will involve the recruitment of patients: 1. Patient interviews to explore their experience of care following an eRAT trigger and 2. Patient use of health services and their quality of life following an eRAT trigger. For 1. only intervention practices will participate, and we'll seek to recruit 12-18 patients for whom an eRAT triggered and the GP made a referral/order investigations. For 2. intervention (N=28) and control (N=28) practices will be recruited, and we'll aim to recruit 140 patients from each arm. In the intervention arm this will be patients who received an eRAT trigger and for whom the GP made a referral/order investigations. In control practices, patients will be those for whom an eRAT would have trigger in the practice and for whom the GP made referral/order investigations. Patients will be invited to participate via the practice. Previous participant inclusion criteria as of 13/01/2023 to 23/01/2023: We will not recruit participants to the main RCT. It is a cluster RCT with the clusters being GP practices across England. Practices must host either Microtest, or SystmOne, principal clinical systems. Only practices completing an agreement to engage with the research processes and the intervention/control arms will be eligible; in a practice agreement the practice will confirm that a practice meeting has taken place and at least fifty per cent of their GPs have agreed to participate in the trial. Practices that are proposing a split or a merger are not eligible. We will also run a series of nested studies which will involve the recruitment of patients: 1. Patient interviews to explore their experience of care following an eRAT trigger and 2. Patient use of health services and their quality of life following an eRAT trigger. For 1. only intervention practices will participate, and we'll seek to recruit 12-18 patients for whom an eRAT triggered and the GP made a referral/order investigations. For 2. intervention (N=28) and control (N=28) practices will be recruited, and we'll aim to recruit 140 patients from each arm. In the intervention arm this will be patients who received an eRAT trigger and for whom the GP made a referral/order investigations. In control practices, patients will be those for whom an eRAT would have trigger in the practice and for whom the GP made referral/order investigations. Patients will be invited to participate via the practice. Previous participant inclusion criteria: We will not recruit participants to this RCT. It is a cluster RCT with the clusters being GP practices across England. 1. Practices must host either Microtest, SystmOne, or Vision principal clinical systems. Only practices completing an agreement to engage with the research processes and the intervention/control arms will be eligible; in a practice agreement
Exclusion criteria
Exclusion criteria: 1. If a practice is planning to merge or restructure over the course of the trial (to the extent that the practice size will change by at least 10%) they will not be permitted to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of the combined six cancers diagnosed during 2-year follow-up that were at Stage 1/2 (early – cure likely) at diagnosis versus Stage 3/4 (late – cure not likely). | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 13/01/2023: A range of secondary outcomes will be examined: 1. The binary stage at diagnosis of a further six cancers without eRATs will be identified from NCRAS and compared between intervention and control practices. This is to investigate the possibility of a ‘spill-over’ effect whereby eRATs are associated with increased diagnostic activity beyond the eRAT cancers. 2. The practice’s number of patients diagnosed with the six eRAT cancers combined, and the total number of cancer cases, from NCRAS. 3. The number of patients investigated or referred under the 2-week wait system for the six eRAT cancers combined, and in total, from Cancer Waiting Times data. 4. Route to diagnosis from the Routes to Diagnosis Dataset, which uses Hospital Episode Statistics data. This will be categorised into four possible routes: emergency attendance, 2-week wait referral, GP referral, and “other”. We will collect this information for each of the six eRAT cancers, and for the six comparator non-eRAT cancers. 5. 2-week wait performance measures, from Cancer Waiting Times data, for the six eRAT cancers combined, and for all cancer referrals: 5.1. Whether a patient on a 2-week wait pathway received a diagnosis of cancer. When aggregated, for example at the practice level, and expressed as the proportion of patients who received a cancer diagnosis, this is known as the conversion rate. 5.2. The duration between the 2-week wait referral and diagnosis of cancer in days 5.3. Whether patients referred on a 2-week wait referral and who received a cancer diagnosis were diagnosed within 28 days, the Faster Diagnosis Standard (introduced in 2022). 5.4. Detection rate – the proportion of a practice’s cancers which are identified via the 2-week wait pathway. 6. Survival measures (from date of diagnosis): 30-day; 1-year (identified from NCRAS). 5-year survival will also be reported, but the main trial will report on 30 days and 1 year, with 5-year data bein | — |
Countries
England, United Kingdom
Contacts
Public ContactRaff Calitri
Outcome results
None listed