Can a complex intervention based on education and a risk prediction tool increase case finding and engagement with treatment for Hepatitis C - interim results of a cluster randomised controlled trial in primary care

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 aims to develop a complex intervention and evidence to support NICE recommendations on HCV infection by identify ways of increasing testing of high risk individuals, and increasing the treatment of newly-diagnosed individuals within primary care.A cluster randomised controlled trial is currently underway in which practices are randomised 1:1 to a complex intervention. The intervention will run for approximately 1 year and will include: An offer of educational training on HCV for practice staff; poster and leaflets displayed in the waiting room; a HCV risk prediction algorithm based on information on possible risk markers in the electronic patient record run using Audit+ software (Informatica Systems Ltd). This will then be used to recall and offer patients a HCV test either opportunistically through pop-ups or by inviting patients by letter. Control practices are following usual care. The effectiveness of the intervention will be 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 will be recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment. Longer term cost-effectiveness of the intervention in improving quality adjusted life years (QALYs) will be extrapolated using a pre-existing dynamic health economic model. Health care workers’ experiences and acceptability of the intervention will be explored through semi-structured qualitative interviews.

Findings

45 practices in total were recruited across the South-West region (22 intervention practices and 23 control practices). Intervention practices have been trained and the Audit+ software installed at each practice. Data collection and analysis are currently underway. Data from patients identified at practices with HCV risk markers will be linked to PHE laboratory data and secondary care data and compared in control and intervention practices.

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.