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?

Conference:

SAPC ASM 2020 - cancelled due to pandemic

Talk Code:

F.14

Presenter:

1 Kirsty Roberts

Twitter:

@BrsTrialsCentre

Co-authors:

Kirsty Roberts1, John Macleod1, Chris Metcalfe1, Jeremy Horwood1, Peter Vickerman1, Peter Muir2, Will Hollingworth1, Clare Clement1, Fiona Gordon3, Will Irving4, Cherry-Ann Waldron5, Matthew Hickman1

Author institutions:

1Bristol Medical School, University of Bristol. 2Public Health Laboratory Bristol, National Infection Service, Public Health England 3University Hospitals Bristol, Bristol Royal Infirmary. 4NIHR Nottingham Digestive Diseases Biomedical Research Unit, University Hospital Nottingham. 5Centre for Trials Research, Cardiff University

Problem

In England there are estimated to be over 100,000 individuals with chronic Hepatitis C Virus (HCV) infection. Since 2016 over 10,000 people per year have been treated for HCV and an estimated 50,000 people have been diagnosed, though many of the latter may not have been assessed or currently under management by HCV services. Primary care is the largest source of HCV testing, comprising of nearly 30% of all HCV antibody positive tests in laboratory surveillance. 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

The objective of the study was to evaluate the effectiveness and cost effectiveness of a complex intervention in primary care that aims to increase uptake of HCV case-finding and treatment.A pragmatic, two-armed, practice level, cluster controlled randomised trial included 45 general practices in the south west England. The intervention included: An offer of educational training on HCV for practice staff; poster and leaflets displayed in the waiting room; electronic algorithm to flag patients with HCV risk markers and invite them for an HCV test. Control practices followed usual care. The effectiveness of the intervention was measured by comparing uptake of HCV testing. Intervention costs and health service utilisation were recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment.

Findings

The total number of flagged patients was 24 473 (about 5% of practice list). 2071 (16%) flagged patients in the intervention practices and 1163 (10%) in control practices were tested for HCV (adjusted rate ratio 1.59, 95% confidence interval 1.21 to 2.08; P<0.001). The “number needed to help” was 792 (558 to 1883) patients flagged for one extra HCV diagnosis, referral, and assessment. The average cost of HCV case finding was £4.03 (£2.27 to £5.80) per at risk patient, £3165 per additional patient assessed at hepatology, and £6212 per quality adjusted life year (QALY) (with 92.5% probability of being below £20 000 per QALY).

Consequences

A complex intervention based around an electronic algorithm integrated with primary care practice systems can increase HCV case finding by a modest amount and be cost effective. The intervention would benefit from being optimised before implementation.

Submitted by:

Kirsty Roberts

Funding acknowledgement:

The trial was funded by the NIHR and Department of Health Policy Research Programme (PRP) (Grant Code 015/0309) and trials registration number: ISRCTN61788850.