Gilead Fellowship

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Developing awareness, educational  interventions  and linkage-integrated care pathways  to increase  Hepatitis B and C case findings in Primary Health Care

The Frimley Viral Hepatitis Programme plays a pivotal role in the loco-regional viral hepatitis network. Frimley(FPH) has led the way in developing novel outreach initiatives within ‘hard to reach’ populations, including the (i)Nepali population and our current support from Gilead Fellowship programme  (ii)Pakistani community/Woking Mosque Project (iii)Pharmacy Hepatitis Programme/Surrey PCT.

There is a commitment from FPH to further develop complex Hepatology services by investment towards the creation of a future regional liver centre serving Surrey, Hampshire and Berkshire. Our proven experience in community health programmes makes us strategically capable of improving the knowledge and awareness of chronic viral hepatitis(CVH) in ethnically diverse populations. We wish to translate this practice to an understanding of CVH as part of linkage/integrated care in the primary health care setting collaborating with Professor Simon de Lusignan, University of Surrey, who has an established international track record in primary care health informatics/quality improvement to encourage primary care professionals prioritising in CVH case finding by targeting high-risk groups.

He  has just completed a major cluster randomised trial showing how audit-based education has improved management of Chronic Kidney Disease(CKD)(1). Prior to 2006, CKD was barely known in primary care – and there are many parallels to be drawn with GPs current non-engagement with CVH.

The project is organised in three linked tasks.

The specific objectives are:

Task 1: A diagnostic analysis using focus groups to  investigate knowledge and attitudes to chronic hepatitis B and C case finding amongst GPs and other health care professionals to improve understanding of factors that inhibit or facilitate testing amongst people from high risk populations e.g. South Asia.

Task 2: To develop a complex intervention for GPs, to increase chronic hepatitis B and C case finding activity with comparative feedback using audit-base education.

Task 3: To conduct a pilot study comparing three different approaches to chronic hepatitis B and C case finding (systematic screening by GPs, opportunistic case finding by GPs with respect to impact on testing uptake and  acceptability).

PURPOSE:

In common with primary care physicians elsewhere, many GPs in UK appear to have knowledge gaps and misperceptions about HBV&HCV(2). Attempts to remedy this by mailed information had limited effect and face-to- face education is resource intensive(3). Research is needed to inform the development of new approaches that will improve GP awareness and http://hbgkk.se/viagra-on-line-us encourage them to prioritise CVH  case finding by targeting high-risk groups. At the same time, research is needed to explore the knowledge and views of members of the South Asian community regarding HBV&HCV causes, testing and treatments, and the socio-cultural norms and religious beliefs about health, disease and individual responsibilities that may reduce confidence in health services and testing uptake(4).

RATIONALE:

Illness and death from HBV&HCV is rising disproportionately and needlessly in immigrant communities, particularly South Asians (5). Early identification of HBV&HCV reduces liver disease (e.g. cirrhosis, liver cancer), and saves lives and www.smithlib.org health care costs, and reduces transmission of the virus to others. However, many South Asians in Britain are not getting tested.

METHODOLOGY:

We will complete the ethical approval process before starting to use employed researcher time, funded through this project.

Setting: Primary care, public health and the South East Asian community, in a 50 mile radius of Frimley, including localities with marked socio-economic and ethnic diversity, and concentrations of people of South Asian origin.

Task 1: Identifying the limiting factors to more active CVH management in primary care.  We hypothesise, but are not certain whether knowledge gaps  limit to HBV&HCV case finding amongst GPs and other health care professionals; and that improving knowledge would improve case finding.  This will be investigated in focus groups in 8 practices (4 each in areas of high and low concentration of South Asian populations). Qualitative methods will be used to gain an understanding of the factors that facilitate and inhibit testing for HBV and HCV.

Task 1: Investigate knowledge and attitudes to HBV&HCV case finding in primary care:

The primary care research network (PCRN) has agreed to help recruit general practices, four each in areas of high and low concentrations of South Asian populations, to take part in lunch time focus groups (with GPs, nurses, managers), facilitated by members of the research team. The aim is to gain an understanding of the factors that facilitate and inhibit the identification and testing of HBV&HCV amongst South Asian patients.

NICE has identified a need to ascertain ‘what knowledge GPs need to be able to identify people at risk and test and expert buy viagra at a discount treat them'(6). Whilst poor knowledge may be an important underlying barrier, other factors such as lack of time or incentives, also affect GP behaviours(7). Participants will be asked about HBV&HCV testing activity in the practice, and what they think would help them to engage in case finding in the South Asian community. Vignettes of hypothetical patients from different backgrounds will be used to explore socio-cultural, religious and communication factors that may affect attitudes to HBV/HCV case finding(8).

Focus groups will be audio-recorded, with all participants consent, transcribed verbatim and analysed using the qualitative data analysis software NVivo (QSR international). The researcher will analyse the transcripts using thematic analysis(9).

Task 2: To develop interventions (a complex intervention, as defined by MRC)(10).Separate interventions for GPs and people from South Asia will be developed in a systematic way using an intervention-mapping framework. This method applies theories and empirically derived perspectives from practitioners and service users in sequential steps to develop an intervention compatible with the target population(11).

The views and attitudes of GPs as to the limiting factors to improve case finding (Task 1) will inform: (a)the development of interventions to help them case find HBV/HCV in the South Asian community, and (b) the development of culturally specific information on HBV/HCV for people from South Asia to improve their understanding and testing uptake. Similarly, evidence from Task 2 (perspectives of South Asian community) will feed into the design of both those interventions.  Prior to implementation, interventions will be discussed with our patient and http://hovawart.org/uk-viagra-sites public involvement (PPI) group, and pilot tested. Written materials will be assessed for whether the messages are comprehendible, communicated effectively, and likely impact on behaviour. (c) We will also audit GP computer records for cases that are recorded as positive in clinical records to explore whether these patients have been managed according to best practice.  We will review these cases and explore whether records audits might significantly improve care compared with other methods of case finding.

Process: Using the four GP practices in Task 1 located in areas with high concentrations of people from South Asian, we will establish, as far as possible, matched pairs of practices (based on list size, socio-demographics, urban/rural location) and allocate one of each pair to conduct systematic screening and the other to undertake opportunistic case finding.

Systematic screening: practice lists will be searched for eligible patients. Ethnicity is increasingly available in GP records, but name recognition software (previously used successfully in health services research(12) will also be used to identify individuals in the target group. The research team includes expertise in primary care and health informatics. GPs will mail the HBV&HCV information and testing invitation to identified patients. Screening uptake will be monitored by the practice and communicated to the research team using ID numbers to maintain patient confidentiality.

Opportunistic case finding: GPs will identify people in the target group when they attend surgery and provide them with the HBV&HCV information and testing invitation, face-to-face. At the outset, the number of people on the practice list in the target group will be assessed using ethnicity recording and name recognition software (as in systematic screening group). The number of invitations issued, and testing uptake will be monitored. The number of missed ‘opportunities’ for case finding will be calculated i.e. the number of eligible patients visiting the practice in the study period who were not given HBV and HCV information/ testing invitations.

Task 3: Pilot study comparing two different approaches to HCV case finding

Design: Experimental; two approaches to HBV&HCV case finding will be compared with respect to their impact on testing uptake, acceptability.

Target population: adults (18 years and over) with South Asian background (1st/2nd generation migrants).

Eligibility criteria: no known HBV&HCV diagnosis; have not been tested for HBV and HCV in last 12 months. Alternatives evaluated:

1.         Systematic screening: invitations for HBV/HCV testing issued by GPs by mail to eligible patients.

2.         Opportunistic case finding: GPs issue invitations for HCV test to eligible patients when they attend the practice .

Interventions developed for GPs in Task 2 will be available to help those conducting opportunistic case finding. Additionally, to promote activity, GPs in this group will be given a financial reward for each invitation issued to eligible people (£8, PCRN rate for 6 minutes GP time to discuss testing with patient), and test taken up (£20, to encourage full GP engagement with patients at the time of giving the invitation). GPs are known to focus on individual QOF targets that are linked to financial reward, and not to prioritise wider public health issues(13). Currently GPs are not financially rewarded for HBV&HCV case finding and low testing is a source of concern(14). Use of financial rewards in this experiment is thus justified.

Research question: The experiment will show whether an informed and incentivised GP inviting patients in a face-to-face situation is better than a mailed invitation from GP at securing HCV testing uptake in the target group.

DELIVERABLES/OUTCOMES:

HBV&HCV testing: Following recent NICE guidelines(15) and as used successfully in our pilot study(14) Dried Blood Spot (DBS) testing technology will be used. A drop of blood from a finger prick is placed on a prepared card and sent to Manchester Medical Microbiology Partnership for analysis. DBS is less invasive than venepuncture, has 100% sensitivity and specificity, and provides information on genotype (and HBV) thereby avoiding the need for additional investigations in those testing positive(16). Recalling patients after saliva tests can lead to compliance problems(16).

Results will be sent to the GP’s who have tested (including those individuals testing negative)  and copied to Prof Ala. Those identified with HBV&HCV will be contacted and offered assessments at FPH or other secondary care provider. All cases will be notified to Health Protection Agency (Notification of infectious diseases Regulations 2012). We will engage with individuals, their GPs and Public Health to track and follow up contacts including vaccination against HBV infection.

Information gathered: Volunteers for testing will provide consent and socio-economic, demographic, ethnic and health information. Other issues will be explored:

(i)How they heard about testing, to ascertain if sharing of the information by the target group was greater through any one approach;

(ii)Level of HBV&HCV risk e.g. place of birth / date that they came to the UK;pilgrimage to Haj (mandatory head shaving in men).

Sample size and recruitment: The primary outcome is uptake of testing. In order to detect, using a 2 sided test and size =5% , power = 90%, a difference in testing uptake rate of 10% between any two approaches, a sample size;>524 would be required in each approach. Prior to comparing approaches, we will assess variability within approaches. Each GP practice will issue 524 invitations, verified by sequential numbering. If there is a statistically significant difference in testing uptake between two sites within an approach, each will be compared separately with the other approaches.

This experiment will be conducted in areas with high concentrations of the target population. People sent invitations in the systematic screening group will be randomly selected from all eligible adults on the practice list. Practices in the opportunistic case finding group will each continue inviting patients until 524 is reached, or to stop issuing invitations after 4 months, whichever occurs first.

Based on our previous pilot study in mosques(14), we expect about 12 % of people invited to testing to accept, and some 3% to test positive. For every 524 invitations issued in each of the six sites, we therefore expect to conduct about 66 tests, and identify about 2 new cases.

Analysis: Chi square tests will be used to compare testing uptake within and between methods. Demographic characteristics of responders and non-responders in GP practices will be compared using appropriate tests.

Acceptability: After testing, volunteers will be asked to complete a brief questionnaire (in English, Punjabi or Urdu) to obtain feedback on the HBV/HCV information, invitation and testing process. Participating GPs, practice managers will be interviewed.

MILESTONES/TIMELINES:

Project set up: (1 month)

Task 1 (2 month) : primary care: Focus groups in GP practices to investigate knowledge/attitudes to HBV&HCV.

Task 2 (4 months): Developing interventions for GP to increase HBV&HCV case finding e.g. brief risk profiling tool and culturally specific information to help communication with South East Asian community.

Task 3 (4 months): Pilot feasibility study to compare 2 different approaches to HBV&HCV case finding among South East Asian community e.g. systemic screening by GP’s (mailed invitations), opportunistic case finding by GP’s.

Final analysis:1 month

STAKEHOLDERS INVOLVED:

Project Steering Group will be set up and meet twice in the year to support and advise the research team. Prof Aftab Ala is the chief investigator and clinical lead for the project.  Prof Simon de Lusignan is a practising GP and health informatics expert with extensive experience in research at the University of surrey. He will provide GP liaison and be responsible for the identification of patients and data extraction from GP records. Dr. Jane Hendy is a Senior Lecturer at University of Surrey. JH will provide expert advice on health psychology and is experienced in quantitative and qualitative research methods and specialises in service innovation uptake. Dr. Margot Nicholls, expert in communicable diseases Surrey Health Protection Agency, and Dr. Shuja Shafi, Deputy Secretary General of the Muslim Council of Britain have agreed to be Group members. The  British Liver Trust have agreed to provide representation and will be chair the meetings.

REFERENCES:

1.Kearns B et al. BMC Nephrol. 2013;14:49

2.Clark E et al. Family Medicine 2005; 37:644-49

3.De Souza R et al. Quarterly Journal of Medicine 2004; 97: 331-336

4.De Souza et al. Quarterly Journal of Medicine 2004; 97: 529-550

5.Health Protection Agency Hepatitis C in the UK, 2012 Report

6.NICE Public Health draft guidance, hepatitis B and C: ways to promote and offer testing to people at increased risk of infection PHG/29 2012

7.Helsper C et al. Family Practice 2010; 27:328–332

8.Zickmund S et al. Digestive Diseases and Sciences 2007;52:2550-6.

9.Braun V  et al. Qualitative research in Psychology 2006. 3:77-101

10. Campbell M et al. Br Med J 2000;321:694-696

11. Litwin AH et al. Digestive and Liver Disease. 2012;44:497-503.

12.Bartholomew LK et al. Health Education and Behaviour 1998; 25: 545-61.

13.Nanchahal K et al. Journal of Public Health Medicine 2001; 23: 278-85.

14. Redhead et al. Hepatology. AASLD, Boston November 2012

15.Litwin AH et al. Digestive and Liver Disease. 2012;44:497-503

16.Coppola AG, et al. American Journal of Gastroenterology 2004;99:1720-9

What would be your key measures of success and how would you measure these?

Early identification of those who are infected from our proposed work will provide an opportunity for life saving, cost effective interventions. Without appropriate targeted information and awareness campaigns, undetected individuals are at significant risk of early death. Early diagnosis and treatment of an individual will also prevent onward transmission, with immediate individual benefit of early treatment, in addition to the very important public health benefits of reducing onward transmission.

The benefits of providing this service would allow us to accurately estimate rates of HBV and HCV in the Nepali community. Understanding this would allow us to design and plan future services for this vulnerable group. Reducing rates of undiagnosed HBV and HCV would also reduce CVH related complications, including cirrhosis and hepatocellular carcinoma.

Please describe how you would assess patient related outcomes.

The Manchester Labs will supply the DBS kits. The clinical staff following the testing sessions will return the samples. All patients will receive verbal (telephone and face to face ) and written results in a letter via the Study Group. All patients diagnosed with Chronic HBV (Hepatitis Surface antigen and Hepatitis e antigen) and HCV RNA quantification will be offered appointments at a specialised local viral hepatitis service to FPH Liver clinic with a letter to their GP. Any patient not registered with a GP will be helped by the support workers to find a local GP.

Outcomes and outputs will arise at each stage of the research and will be widely generalizable within the NHS.

Task 1 identifies the relative importance of knowledge gaps, cultural factors, attitudes and other barrier barriers that inhibit HCV and HBV case finding amongst south Asians in primary care. It address the question raised by NICE ‘what knowedge do GPS need to be able to identify people at risk and test and treat them, and will provide information for policy makers, practitioners and commissioners about what would help practice staff engage in case finding .

Task 2 combines the perspectives of primary care practitioners and South Asian people to develop interventions to improve case finding and testing uptake. For GPs these will include a brief risk profiling tool, strategies to improve opportunistic case finding (e.g. screen alerts); and culturally tailored information to address communication difficulties about HCV with patients from South Asia. For members of the South Asian community, culturally appropriate information on viral hepatitis (dangers for individuals and families, benefits and processes of testing), will be produced in simple English, Punjabi and Urdu.

Task 3 combines the perspectives of primary care practitioners and South Asian people to develop interventions to improve case finding and testing uptake.

Two alternative means of HBV/HCV screening/case finding (systematic mailed invitations by GPs, opportunistic face-to-face invitations by GPs).This addresses the need identified by NICE for evidence to inform policy on the most effective ways of getting people from high risk groups into testing(6).

Interventions developed for GPs in Task 3 will be available to help those conducting opportunistic case finding.

Additionally, to promote activity, GPs in this group will be given a financial reward for each invitation issued to eligible people (£8, PCRN rate for 6 minutes GP time to discuss testing with patient), and test taken up (£20, to encourage full GP engagement with patients at the time of giving the invitation).