Can a complex intervention based on education and a risk prediction tool increase testing and diagnosis of Hepatitis C? - results of a cluster randomised controlled trial in primary care (HepCATT)
Problem
Public Health England (PHE) estimates that there are upwards of 160,000 individuals in England and Wales with chronic Hepatitis C Virus (HCV) infection, but thus far, only around 100,000 laboratory diagnoses have been reported to PHE and, of these, 28,000 have been treated. Thus, there is a significant number of infected individuals in whom the diagnosis has not been made and a large number of people who have not been treated. Targeted case finding in primary care is estimated to be cost-effective, but there is no robust RCT evidence of specific interventions.
Approach
This study aimed to develop a complex intervention and generate evidence to support NICE recommendations on HCV infection by identifying ways of increasing testing of high risk individuals, and increasing the treatment of newly-diagnosed individuals within primary care.A cluster randomised controlled trial in which practices were randomised 1:1 to a complex intervention was carried out. The intervention included: An offer of educational training on HCV for practice staff; poster and leaflets displayed in the waiting room; an HCV risk prediction algorithm based on information on possible risk markers in the electronic patient record run using Audit+ software (Informatica Systems Ltd). This was then used to recall and offer patients an HCV test either opportunistically through pop-ups or by inviting patients by letter. Control practices followed usual care. The effectiveness of the intervention was measured by comparing rates of HCV testing, the number and proportion of patients testing positive, onward referral, rates of specialist assessment and treatment in control and intervention practices. Intervention costs and health service utilisation were recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment.
Findings
45 practices in total across the South-West area were recruited and data successfully collected from 22 intervention practices and 21 control practices. Data from patients with HCV risk markers identified at practices were linked to PHE laboratory data and compared in control and intervention practices. Data analysis is currently underway. We will be presenting the main results from the trial, specifically the effectiveness of the intervention within primary care.
Consequences
This trial has the potential to make an important impact on patient care and will provide high quality evidence to help general practitioners make important decisions on HCV testing and onward referral. If found to be effective and cost-effective the intervention is readily scalable and can be used to support the implementation of NICE recommendations on HCV case-finding.