Integrating Hepatitis C Care for Opioid Substitution Treatment Patients Attending General Practice: Feasibility, Clinical, and Cost-Effectiveness Analysis.

BACKGROUND: Hepatitis C virus (HCV) infection is common among people who inject drugs, yet well-described barriers mean that only a minority have accessed HCV treatment. Recent developments in HCV diagnosis and treatment facilitate innovative approaches to HCV care that improve access to, and uptake of, care by people who inject drugs. OBJECTIVE: This study aims to examine feasibility, acceptability, likely clinical effectiveness, and cost-effectiveness of an integrated model of HCV care for patients receiving opioid substitution treatment in general practice. METHODS: A pre- and postintervention design with an embedded economic analysis was used to establish the feasibility, acceptability, and clinical and cost-effectiveness of a complex intervention to optimize HCV identification and linkage to HCV treatment among patients prescribed methadone in primary care. The "complex intervention" comprised general practitioner (GP)/practice staff education, nurse-led clinical support, and enhanced community-based HCV assessment of patients. General practices in North Dublin were recruited from the professional networks of the research team and from GPs who attended educational sessions. RESULTS: A total of 135 patients from 14 practices participated. Follow-up data were collected 6 months after intervention from 131 (97.0%) patients. With regard to likely clinical effectiveness, among patients with HCV antibody positivity, there was a significant increase in the proportions of patients who had a liver FibroScan (17/101, 16.8% vs 52/100, 52.0%; P<.001), had attended hepatology/infectious diseases services (51/101, 50.5% vs 61/100 61.0%; P=.002), and initiated treatment (20/101, 19.8% vs 30/100, 30.0%; P=.004). The mean incremental cost-effectiveness ratio of the intervention was €13,255 (US $13,965.14) per quality-adjusted life-year gained at current full drug list price (€39,729 [US $41,857.48] per course), which would be cost saving if these costs are reduced by 88%. CONCLUSIONS: The complex intervention involving clinical support, access to assessment, and practitioner education has the potential to enhance patient care, improving access to assessment and treatment in a cost-effective manner.

Integrating hepatitis C care for at-risk groups (HepLink): baseline data from a multicentre feasibility study in primary and community care.

OBJECTIVES: To examine HCV prevalence and management among people who inject drugs (PWID) attending primary care and community-based health services at four European sites using baseline data from a multicentre feasibility study of a complex intervention (HepLink). METHODS: Primary care and community-based health services in Dublin, London, Bucharest and Seville were recruited from the professional networks of the HepLink consortium. Patients were eligible to participate if aged ≥18 years, on opioid substitution treatment or at risk of HCV (i.e. injecting drug use, homeless or incarcerated), and attended the service. Data on patient demographics and prior HCV management were collected on participants at baseline. RESULTS: Twenty-nine primary care and community-based health services and 530 patients were recruited. Baseline data were collected on all participants. Participants' mean age ranged from 35 (Bucharest) to 51 years (London), with 71%-89% male. Prior lifetime HCV antibody testing ranged from 65% (Bucharest) to 95% (Dublin) and HCV antibody positivity among those who had been tested ranged from 78% (Dublin) to 95% (Bucharest). Prior lifetime HCV RNA testing among HCV antibody-positive participants ranged from 17% (Bucharest) to 84% (London). Among HCV antibody- or RNA-positive participants, prior lifetime attendance at a hepatology/infectious disease service ranged from 6% (London) to 50% (Dublin) and prior lifetime HCV treatment initiation from 3% (London) to 33% (Seville). CONCLUSIONS: Baseline assessment of the HCV cascade of care among PWID attending primary care and community-based health services at four European sites identified key aspects of the care cascade at each site that need to be improved.

Hepatitis C Prevalence and Management Among Patients Receiving Opioid Substitution Treatment in General Practice in Ireland: Baseline Data from a Feasibility Study.

BACKGROUND: Hepatitis C virus (HCV) infection is a major cause of chronic liver disease and death. Injection drug use is now one of the main routes of transmission of HCV in Ireland and globally with an estimated 80% new infections occurring among people who inject drugs (PWID). OBJECTIVE: We aimed to examine whether patients receiving opioid substitution therapy in primary care practices in Ireland were receiving guideline-adherent care regarding HCV screening. Ireland has developed a model of care for delivering opioid substitution treatment in the primary care setting. We conducted this study given the shift of providing care for PWID from secondary to primary care settings, in light of current guidelines aimed at scaling up interventions to reduce chronic HCV infection and associated mortality. METHODS: We included baseline data from the Dublin site of the Heplink study, a feasibility study focusing on developing complex interventions to enhance community-based HCV treatment and improve the HCV care pathway between primary and secondary care. We recruited 14 opioid substitution treatment-prescribing general practices that employed the administration of opioid substitution therapy from the professional networks and databases of members of the research consortium. A standardized nonprobability sampling framework was used to identify 10 patients from each practice to participate in the study. Patients were eligible if aged ≥18 years, on opioid substitution treatment, and attending the practice for any reason during the recruitment period. The baseline data were collected from the clinical records of participating patients. We collected and analyzed data on demographic characteristics, care processes and outcomes regarding HCV and other blood-borne viruses, urinalysis test results, alcohol use disorders, chronic illness, and health service utilization. We examined whether patients received care concordant with guidelines related to HCV screening and care. RESULTS: The baseline data were collected from clinical records of 134 patients; 72.2% (96/134) were males; (mean age 43, SD 7.6; range 27-71 years); 94.8% (127/134) of patients had been tested for anti-HCV antibody in their lifetime; of those, 77.9% (99/127) tested positive. Then, 83.6% (112/134) of patients had received an HIV antibody test in their lifetime; of those, 6.3% (7/112) tested HIV positive. Moreover, 66.4% (89/134) of patients had been tested for hepatitis B virus in their lifetime and 8% (7/89) of those were positive. In the 12 months before the study, 30.6% (41/134) of patients were asked about their alcohol use by their general practitioner, 6.0% (8/134) received a brief intervention, and 2.2% (3/134) were referred to a specialist addiction or alcohol treatment service. CONCLUSIONS: With general practice and primary care playing an increased role in HCV care, this study highlights the importance of prioritizing the development and evaluation of real-world clinical solutions that support patients from diagnosis to treatment completion.

Integrated Hepatitis C Care for People Who Inject Drugs (Heplink): Protocol for a Feasibility Study in Primary Care.

BACKGROUND: Hepatitis C virus (HCV) infection is a major cause of chronic liver disease and death. Drug use remains the significant cause of new infections in the European Union, with estimates of HCV antibody prevalence among people who inject drugs ranging from 5% to 90% in 29 European countries. In Ireland and the European Union, primary care is a key area to focus efforts to enhance HCV diagnosis and treatment among people who inject drugs. OBJECTIVE: The Heplink study aims to improve HCV care outcomes among opiate substitution therapy (OST) patients in general practice by developing an integrated model of HCV care and evaluating its feasibility, acceptability, and likely efficacy. METHODS: The integrated model of care comprises education of community practitioners, outreach of an HCV-trained nurse into general practitioner (GP) practices, and enhanced access of patients to community-based evaluation of their HCV disease (including a novel approach to diagnosis, that is, Echosens FibroScan Mini 430). A total of 24 OST-prescribing GP practices were recruited from the professional networks and databases of members of the research consortium. Patients were eligible if they are aged ≥18 years, on OST, and attend the practice for any reason during the recruitment period. Baseline data on HCV care processes and outcomes were extracted from the clinical records of participating patients. RESULTS: This study is ongoing and has the potential to make an important impact on patient care and provide high-quality evidence to help GPs make important decisions on HCV testing and onward referral. CONCLUSIONS: A substantial proportion of HCV-positive patients on OST in general practice are not engaged with specialist hospital services but qualify for direct-acting antiviral drugs treatment. The Heplink model has the potential to reduce HCV-related morbidity and mortality. REGISTERED REPORT IDENTIFIER: RR1-10.2196/9043.

Hepcare Europe - bridging the gap in the treatment of hepatitis C: study protocol.

BACKGROUND: Hepatitis C (HCV) infection is highly prevalent among people who inject drugs (PWID). Many PWID are unaware of their infection and few have received HCV treatment. Recent developments in treatment offer cure rates >90%. However, the potential of these treatments will only be realised if HCV identification among PWID with linkage to treatment is optimised. This paper describes the Hepcare Europe project, a collaboration between five institutions across four member states (Ireland, UK, Spain, Romania), to develop, implement and evaluate interventions to improve the identification, evaluation and treatment of HCV among PWID. METHODS: A service innovation project and a mixed-methods, pre-post intervention study, Hepcare will design and deliver interventions in Dublin, London, Seville and Bucharest to enhance PWID engagement and retention in the cascade of HCV care. RESULTS: The feasibility, acceptability, potential efficacy and cost-effectiveness of these interventions to improve care processes and outcomes among PWID will be evaluated. CONCLUSION: Hepcare has the potential to make an important impact on patient care for marginalised populations who might otherwise go undiagnosed and untreated. Lessons learned from the study can be incorporated into national and European guidelines and strategies for HCV.

Identified mental disorders in older adults in primary care: A cross-sectional database study.

INTRODUCTION: Identifying and managing mental disorders among older adults is an important challenge for primary care in Europe. Electronic medical records (EMRs) offer considerable potential in this regard, although there is a paucity of data on their use for this purpose. OBJECTIVES: To examine the prevalence/treatment of identified mental disorders among older adults (over 55 years) by using data derived from EMRs in general practice. METHODS: We utilized data from a cross-sectional study of mental disorders in primary care, which identified patients with mental disorders based on diagnostic coding and prescribed medicines. We collected anonymized data from 35 practices nationally from June 2014 to March 2015, and secondary analysis of this dataset examined the prevalence of mental disorders in adults aged over 55 years. RESULTS: 74,261 patients aged over 55 years were identified, of whom 14,143 had a mental health disorder (prevalence rate of 19.1%). There was considerable variation between practices (range: 3.7-38.9%), with a median prevalence of 23.1%. Prevalence increased with age, from 14.8% at 55-59 years to 28.9% at 80-84 years. Most common disorders were depression (17.1%), panic/anxiety (11.3%), cognitive (5.6%), alcohol (3.8%) and substance use (3.8%). CONCLUSIONS: Examining mental disorders among older adults using data derived from EMRs is feasible. Mental disorders are common among older adults attending primary care and this study demonstrates the utility of electronic medical records in epidemiological studies of large populations in primary care.

Preventing blood-borne virus infection in people who inject drugs in the UK: systematic review, stakeholder interviews, psychosocial intervention development and feasibility randomised controlled trial.

BACKGROUND: Opioid substitution therapy and needle exchanges have reduced blood-borne viruses (BBVs) among people who inject drugs (PWID). Some PWID continue to share injecting equipment. OBJECTIVES: To develop an evidence-based psychosocial intervention to reduce BBV risk behaviours and increase transmission knowledge among PWID, and conduct a feasibility trial among PWID comparing the intervention with a control. DESIGN: A pragmatic, two-armed randomised controlled, open feasibility trial. Service users were Steering Group members and co-developed the intervention. Peer educators co-delivered the intervention in London. SETTING: NHS or third-sector drug treatment or needle exchanges in Glasgow, London, Wrexham and York, recruiting January and February 2016. PARTICIPANTS: Current PWID, aged ≥ 18 years. INTERVENTIONS: A remote, web-based computer randomisation system allocated participants to a three-session, manualised, psychosocial, gender-specific group intervention delivered by trained facilitators and BBV transmission information booklet plus treatment as usual (TAU) (intervention), or information booklet plus TAU (control). MAIN OUTCOME MEASURES: Recruitment, retention and follow-up rates measured feasibility. Feedback questionnaires, focus groups with participants who attended at least one intervention session and facilitators assessed the intervention's acceptability. RESULTS: A systematic review of what works to reduce BBV risk behaviours among PWID; in-depth interviews with PWID; and stakeholder and expert consultation informed the intervention. Sessions covered improving injecting technique and good vein care; planning for risky situations; and understanding BBV transmission. Fifty-six per cent (99/176) of eligible PWID were randomised: 52 to the intervention group and 47 to the control group. Only 24% (8/34) of male and 11% (2/18) of female participants attended all three intervention sessions. Overall, 50% (17/34) of men and 33% (6/18) of women randomised to the intervention group and 47% (14/30) of men and 53% (9/17) of women randomised to the control group were followed up 1 month post intervention. Variations were reported by location. The intervention was acceptable to both participants and facilitators. At 1 month post intervention, no increase in injecting in 'risky' sites (e.g. groin, neck) was reported by participants who attended at least one session. PWID who attended at least one session showed a trend towards greater reduction in injecting risk behaviours, a greater increase in withdrawal planning and were more confident about finding a vein. A mean cost of £58.17 per participant was calculated for those attending one session, £148.54 for those attending two sessions and £270.67 for those attending all three sessions, compared with £0.86 in the control group. Treatment costs across the centres vary as a result of the different levels of attendance, as total session costs are divided by attendees to obtain a cost per attendee. The economic analysis suggests that a cost-effectiveness study would be feasible given the response rates and completeness of data. However, we have identified aspects where the service use questionnaire could be abbreviated given the low numbers reported in several care domains. No adverse events were reported. CONCLUSIONS: As only 19% of participants attended all three intervention sessions and 47% were followed up 1 month post intervention, a future definitive randomised controlled trial of the intervention is not feasible. Exposure to information on improving injecting techniques did not encourage riskier injecting practices or injecting frequency, and benefits were reported among attendees. The intervention has the potential to positively influence BBV prevention. Harm reduction services should ensure that the intervention content is routinely delivered to PWID to improve vein care and prevent BBVs. FUTURE WORK: The intervention did not meet the complex needs of some PWID, more tailoring may be needed to reach PWID who are more frequent injectors, who are homeless and female. LIMITATIONS: Intervention delivery proved more feasible in London than other locations. Non-attendance at the York trial site substantially influenced the results. TRIAL REGISTRATION: Current Controlled Trials ISRCTN66453696 and PROSPERO 014:CRD42014012969. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 72. See the NIHR Journals Library website for further project information.

A Systematic Review and Meta-analysis of Psychosocial Interventions to Reduce Drug and Sexual Blood Borne Virus Risk Behaviours Among People Who Inject Drugs.

Opiate substitution treatment and needle exchanges have reduced blood borne virus (BBV) transmission among people who inject drugs (PWID). Psychosocial interventions could further prevent BBV. A systematic review and meta-analysis examined whether psychosocial interventions (e.g. CBT, skills training) compared to control interventions reduced BBV risk behaviours among PWID. 32 and 24 randomized control trials (2000-May 2015 in MEDLINE, PsycINFO, CINAHL, Cochrane Collaboration and Clinical trials, with an update in MEDLINE to December 2016) were included in the review and meta-analysis respectively. Psychosocial interventions appear to reduce: sharing of needles/syringes compared to education/information (SMD -0.52; 95% CI -1.02 to -0.03; I2 = 10%; p = 0.04) or HIV testing/counselling (SMD -0.24; 95% CI -0.44 to -0.03; I2 = 0%; p = 0.02); sharing of other injecting paraphernalia (SMD -0.24; 95% CI -0.42 to -0.06; I2 = 0%; p < 0.01) and unprotected sex (SMD -0.44; 95% CI -0.86 to -0.01; I2 = 79%; p = 0.04) compared to interventions of a lesser time/intensity, however, moderate to high heterogeneity was reported. Such interventions could be included with other harm reduction approaches to prevent BBV transmission among PWID.

The acceptability and feasibility of a brief psychosocial intervention to reduce blood-borne virus risk behaviours among people who inject drugs: a randomised control feasibility trial of a psychosocial intervention (the PROTECT study) versus treatment as usual.

BACKGROUND: While opiate substitution therapy and injecting equipment provision (IEP) have reduced blood-borne viruses (BBV) among people who inject drugs (PWID), some PWID continue to share injecting equipment and acquire BBV. Psychosocial interventions that address risk behaviours could reduce BBV transmission among PWID. METHODS: A pragmatic, two-armed randomised controlled, open feasibility study of PWID attending drug treatment or IEP in four UK regions. Ninety-nine PWID were randomly allocated to receive a three-session manualised psychosocial group intervention and BBV transmission information booklet plus treatment as usual (TAU) (n = 52) or information booklet plus TAU (n = 47). The intervention was developed from evidence-based literature, qualitative interviews with PWID, key stakeholder consultations, and expert opinion. Recruitment rates, retention in treatment, follow-up completion rates and health economic data completion measured feasibility. RESULTS: Fifty-six percent (99/176) of eligible PWID were recruited. More participants attended at least one intervention session in London (10/16; 63%) and North Wales (7/13; 54%) than in Glasgow (3/12; 25%) and York (0/11). Participants who attended no sessions (n = 32) compared to those attending at least one (n = 20) session were more likely to be homeless (56 vs 25%, p = 0.044), injected drugs for a greater number of days (median 25 vs 6.5, p = 0.019) and used a greater number of needles from an IEP in the last month (median 31 vs 20, p = 0.056). No adverse events were reported. 45.5% (45/99) were followed up 1 month post-intervention. Feedback forms confirmed that the intervention was acceptable to both intervention facilitators and participants who attended it. Follow-up attendance was associated with fewer days of injecting in the last month (median 14 vs 27, p = 0.030) and fewer injections of cocaine (13 vs 30%, p = 0.063). Analysis of the questionnaires identified several service use questionnaire categories that could be excluded from the assessment battery in a full-randomised controlled trial. CONCLUSIONS: Findings should be interpreted with caution due to small sample sizes. A future definitive RCT of the psychosocial intervention is not feasible. The complex needs of some PWID may have limited their engagement in the intervention. More flexible delivery methods may have greater reach. TRIAL REGISTRATION: ISRCTN66453696.

Feasibility of alcohol screening among patients receiving opioid treatment in primary care.

BACKGROUND: Identifying and treating problem alcohol use among people who also use illicit drugs is a challenge. Primary care is well placed to address this challenge but there are several barriers which may prevent this occurring. The objective of this study was to determine if a complex intervention designed to support screening and brief intervention for problem alcohol use among people receiving opioid agonist treatment is feasible and acceptable to healthcare providers and their patients in a primary care setting. METHODS: A randomised, controlled, pre-and-post design measured feasibility and acceptability of alcohol screening based on recruitment and retention rates among patients and practices. Efficacy was measured by screening and brief intervention rates and the proportion of patients with problem alcohol use. RESULTS: Of 149 practices that were invited, 19 (12.8 %) agreed to participate. At follow up, 13 (81.3 %) practices with 81 (62.8 %) patients were retained. Alcohol screening rates in the intervention group were higher at follow up than in the control group (53 % versus 26 %) as were brief intervention rates (47 % versus 19 %). Four (18 %) people reduced their problem drinking (measured by AUDIT-C), compared to two (7 %) in the control group. CONCLUSIONS: Alcohol screening among people receiving opioid agonist treatment in primary care seems feasible. A definitive trial is needed. Such a trial would require over sampling and greater support for participating practices to allow for challenges in recruitment of patients and practices.

Psychosocial Interventions for Problem Alcohol Use in Primary Care Settings (PINTA): Baseline Feasibility Data.

OBJECTIVE: Many individuals receiving methadone maintenance receive their treatment through their primary care provider. As many also drink alcohol excessively, there is a need to address alcohol use to improve health outcomes for these individuals. We examined problem alcohol use and its treatment among people attending primary care for methadone maintenance treatment, using baseline data from a feasibility study of an evidence-based complex intervention to improve care. METHODS: Data on addiction care processes were collected by (1) reviewing clinical records (n = 129) of people who attended 16 general practices for methadone maintenance treatment and (2) administering structured questionnaires to both patients (n = 106) and general practitioners (GPs) (n = 15). RESULTS: Clinical records indicated that 24 patients (19%) were screened for problem alcohol use in the 12 months prior to data collection, with problem alcohol use identified in 14 (58% of those screened, 11% of the full sample). Of those who had positive screening results for problem alcohol use, five received a brief intervention by a GP and none were referred to specialist treatment. Scores on the Alcohol Use Disorders Identification Test (AUDIT) revealed the prevalence of hazardous, harmful, and dependent drinking to be 25% (n = 26), 6% (n = 6), and 16% (n = 17), respectively. The intraclass correlation coefficient (ICC) for the proportion of patients with negative AUDITs was 0.038 (SE = 0.01). The ICCs for screening, brief intervention, and/or referral to treatment (SBIRT) were 0.16 (SE = 0.014), -0.06 (SE = 0.017), and 0.22 (SE = 0.026), respectively. Only 12 (11.3%) AUDIT questionnaires concurred with corresponding clinical records that a patient had any/no problem alcohol use. Regular use of primary care was evident, as 25% had visited their GP more than 12 times during the past 3 months. CONCLUSIONS: Comparing clinical records with patients' experience of SBIRT can shed light on the process of care. Alcohol screening in people who attend primary care for substance use treatment is not routinely conducted. Interventions that enhance the care of problem alcohol use among this high-risk group are a priority.

Screening for atrial fibrillation in general practice: a national, cross-sectional study of an innovative technology.

BACKGROUND: To test the use of three lead monitoring as a screening tool for atrial fibrillation (AF) in general practice. AF is responsible for up to a quarter of all strokes and is often asymptomatic until a stroke occurs. METHODS: 26 randomly selected general practices identified 80 randomly selected patients aged 70 or older from their database and excluded those known to have AF, those with clinical issues or who had not attended for three years. Up to 40 eligible patients/practice were invited to attend for screening. A 2min three-lead ECG was recorded and collected centrally for expert cardiology assessment. Risk factor data was gathered. OUTCOMES: (i) point prevalence of AF, (ii) proportion of ECG tracings which were adequate for interpretation, (iii) uptake rate by patients and (iv) acceptability of the screening process to patients and staff (reported separately). RESULTS: Of 1447 current patients, 1003 were eligible for inclusion, 639 (64%) agreed to take part in screening and 566 (56%) completed screening. The point prevalence rate for AF was 10.3%-2.1% new cases (12 of 566 who were screened) and 9.5% existing cases (137 of 1447 eligible patients). Only four of 570 (0.7%) screening visits did not record a usable ECG and 11 (2.6%) three lead ECGs required a clarifying 12 lead ECG. CONCLUSIONS: Three lead screening for AF is feasible, effective and offers an alternative to pulse taking or 12 lead ECGs. The availability of this technology may facilitate more effective screening, leading to reduced stroke incidence.

Barriers to and facilitators of hepatitis C testing, management, and treatment among current and former injecting drug users: a qualitative exploration.

Hepatitis C (HCV) infection is common among injecting drug users (IDUs), yet accessing of HCV care, particularly HCV treatment, is suboptimal. There has been little in-depth study of IDUs experiences of what enables or prevents them engaging at every level of HCV care, including testing, follow-up, management and treatment processes. This qualitative study aimed to explore these issues with current and former IDUs in the greater Dublin area, Ireland. From September 2007 to September 2008 in-depth interviews were conducted with 36 service-users across a range of primary and secondary care services, including: two addiction clinics, a general practice, a community drop-in center, two hepatology clinics, and an infectious diseases clinic. Interviews were analyzed using a grounded theory approach. Barriers to HCV care included perceptions of HCV infection as relatively benign, fear of investigations and treatment, and feeling well. Perceptions were shaped by the discourse about HCV and "horror stories" about the liver biopsy and treatment within their peer networks. Difficulties accessing HCV care included limited knowledge of testing sites, not being referred for specialist investigations and ineligibility for treatment. Employment, education, and addiction were priorities that competed with HCV care. Relationships with health care providers influenced engagement with care: Trust in providers, concern for the service-user, and continuity of care fostered engagement. Education on HCV infection, investigations, and treatment altered perceptions. Becoming symptomatic, responsibilities for children, and wanting to move on from drug use motivated HCV treatment. In conclusion, IDUs face multiple barriers to HCV care. A range of facilitators were identified that could inform future interventions.