Effectiveness of Transitional Care Program among High-Risk Discharged Patients: A Quasi-Experimental Study on Saving Costs, Post-Discharge Readmissions and Emergency Department Visits.

Transitional care programs (TCPs), where hospital care team members repeatedly follow up with discharged patients, aim to reduce post-discharge hospital or emergency department (ED) utilization and healthcare costs. We examined the effectiveness of TCPs at reducing healthcare costs, hospital readmissions, and ED visits. Centers for Medicare and Medicaid Services Bundled Payments for Care Improvement (BPCI) program adjudicated claims files and electronic health records from Greenville Memorial Hospital, Greenville, SC, were accessed. Data on post-discharge 30- and 90-day ED visits and readmissions, total costs, and episodes with costs over BPCI target prices were extracted from November 2017 to July 2020 and compared between the "TCP-Graduates" (N = 85) and "Did Not Graduate" (DNG) (N = 1310) groups. As compared to the DNG group, the TCP-Graduates group had significantly fewer 30-day (7.1% vs. 14.9%, p = 0.046) and 90-day (15.5% vs. 26.3%, p = 0.025) readmissions, episodes with total costs over target prices (25.9% vs. 36.6%, p = 0.031), and lower total cost/episode (USD 22,439 vs. USD 28,633, p = 0.018), but differences in 30-day (9.4% vs. 11.2%, p = 0.607) and 90-day (20.0% vs. 21.9%, p = 0.680) ED visits were not significant. TCP was associated with reduced post-discharge hospital readmissions, total care costs, and episodes exceeding target prices. Further studies with rigorous designs and individual-level data should test these findings.

Cost-effectiveness of Hepatitis C Virus Treatment Models for People Who Inject Drugs in Opioid Agonist Treatment Programs.

BACKGROUND: Many people who inject drugs in the United States have chronic hepatitis C virus (HCV). On-site treatment in opiate agonist treatment (OAT) programs addresses HCV treatment barriers, but few evidence-based models exist. METHODS: We evaluated the cost-effectiveness of HCV treatment models for OAT patients using data from a randomized trial conducted in Bronx, New York. We used a decision analytic model to compare self-administered individual treatment (SIT), group treatment (GT), directly observed therapy (DOT), and no intervention for a simulated cohort with the same demographic characteristics of trial participants. We projected long-term outcomes using an established model of HCV disease progression and treatment (hepatitis C cost-effectiveness model: HEP-CE). Incremental cost-effectiveness ratios (ICERs) are reported in 2016 US$/quality-adjusted life years (QALY), discounted 3% annually, from the healthcare sector and societal perspectives. RESULTS: For those assigned to SIT, we projected 89% would ever achieve a sustained viral response (SVR), with 7.21 QALYs and a $245 500 lifetime cost, compared to 22% achieving SVR, with 5.49 QALYs and a $161 300 lifetime cost, with no intervention. GT was more efficient than SIT, resulting in 0.33 additional QALYs and a $14 100 lower lifetime cost per person, with an ICER of $34 300/QALY, compared to no intervention. DOT was slightly more effective and costly than GT, with an ICER > $100 000/QALY, compared to GT. In probabilistic sensitivity analyses, GT and DOT were preferred in 91% of simulations at a threshold of <$100 000/QALY; conclusions were similar from the societal perspective. CONCLUSIONS: All models were associated with high rates of achieving SVR, compared to standard care. GT and DOT treatment models should be considered as cost-effective alternatives to SIT.

Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study.

BACKGROUND: Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) - results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection. METHODS: The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT. CONCLUSIONS: This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.

Evaluating reimbursement of integrated support services using chronic care management (CCM) codes for treatment of hepatitis C among Medicare beneficiaries.

The New York City Department of Health and Mental Hygiene (DOHMH) implemented Project INSPIRE, an integrated model of hepatitis C care coordination and telementoring services, from 2014 to 2017. We evaluated the use of chronic care management (CCM) codes to sustain the intervention. DOHMH data were collected as part of a Healthcare Innovation Award from the Centers for Medicare & Medicaid Services (CMS). A retrospective cohort medical billing study was conducted by assigning INSPIRE activities to procedure codes in both facility and nonfacility settings. Rates for procedures were extracted from the CMS's 2018 fee schedules and added across the eligibility periods for Medicare enrollees. Reimbursement was adjusted on the basis of expected patient attrition and compared to costs. The minimum number needed to treat (NNT) to break even was calculated in each setting. Facility reimbursement was higher than costs, whereas nonfacility reimbursement was lower (both P < .01). The NNT was 23 patients in facilities and 33 patients in nonfacilities; 24 patients per care coordinator were treated annually in INSPIRE. CCM fees alone were insufficient to fully reimburse the costs in either setting. Implementation of an appropriate risk financing strategy is necessary to mitigate financial shortfalls when providing CCM services in facility settings.

A Cost Reimbursement Model for Hepatitis C Treatment Care Coordination.

OBJECTIVE: To estimate the cost of delivering a hepatitis C virus care coordination program at 2 New York City health care provider organizations and describe a potential payment model for these currently nonreimbursed services. DESIGN: An economic evaluation of a hepatitis C care coordination program was conducted using micro-costing methods compared with macro-costing methods. A potential payment model was calculated for 3 phases: enrollment to treatment initiation, treatment initiation to treatment completion, and a bonus payment for laboratory evidence of successful treatment outcome (sustained viral response). SETTING: Two New York City health care provider organizations. PARTICIPANTS: Care coordinators and peer educators delivering care coordination services were interviewed about time spent on service provision. De-identified individual-level data on study participant utilization of services were also used. INTERVENTION: Project INSPIRE is an innovative hepatitis C care coordination program developed by the New York City Department of Health and Mental Hygiene. MAIN OUTCOME MEASURES: Average cost per participant per episode of care for 2 provider organizations and a proposed payment model. RESULTS: The average cost per participant at 1 provider organization was $787 ($522 nonoverhead cost, $264 overhead) per episode of care (5.6 months) and $656 ($429 nonoverhead cost, $227 overhead, 5.7 months) at the other one. The first organization had a lower macro-costing estimate ($561 vs $787) whereas the other one had a higher macro-costing estimate ($775 vs $656). In the 3-phased payment model, phase 1 reimbursement would vary between the provider organizations from approximately $280 to $400, but reimbursement for both organizations would be approximately $220 for phase 2 and approximately $185 for phase 3. CONCLUSIONS: The cost of this 5.6-month care coordination intervention was less than $800 including overhead or less than $95 per month. A 3-phase payment model is proposed and requires further evaluation for implementation feasibility. Project INSPIRE's HCV care coordination program provides good value for a cost of less than $95 per participant per month. The payment model provides an incentive for successful cure of hepatitis C with a bonus payment; using the bonus payment to support HCV tele-mentoring expands HCV treatment capacity and empowers more primary care providers to treat their own patients with HCV.

Research priorities to achieve universal access to hepatitis C prevention, management and direct-acting antiviral treatment among people who inject drugs.

Globally, it is estimated that 71.1 million people have chronic hepatitis C virus (HCV) infection, including an estimated 7.5 million people who have recently injected drugs (PWID). There is an additional large, but unquantified, burden among those PWID who have ceased injecting. The incidence of HCV infection among current PWID also remains high in many settings. Morbidity and mortality due to liver disease among PWID with HCV infection continues to increase, despite the advent of well-tolerated, simple interferon-free direct-acting antiviral (DAA) HCV regimens with cure rates >95%. As a result of this important clinical breakthrough, there is potential to reverse the rising burden of advanced liver disease with increased treatment and strive for HCV elimination among PWID. Unfortunately, there are many gaps in knowledge that represent barriers to effective prevention and management of HCV among PWID. The Kirby Institute, UNSW Sydney and the International Network on Hepatitis in Substance Users (INHSU) established an expert round table panel to assess current research gaps and establish future research priorities for the prevention and management of HCV among PWID. This round table consisted of a one-day workshop held on 6 September, 2016, in Oslo, Norway, prior to the International Symposium on Hepatitis in Substance Users (INHSU 2016). International experts in drug and alcohol, infectious diseases, and hepatology were brought together to discuss the available scientific evidence, gaps in research, and develop research priorities. Topics for discussion included the epidemiology of injecting drug use, HCV, and HIV among PWID, HCV prevention, HCV testing, linkage to HCV care and treatment, DAA treatment for HCV infection, and reinfection following successful treatment. This paper highlights the outcomes of the roundtable discussion focused on future research priorities for enhancing HCV prevention, testing, linkage to care and DAA treatment for PWID as we strive for global elimination of HCV infection.

The common sense model applied to hepatitis C: a qualitative analysis of the impact of disease comparison and witnessed death on hepatitis C illness perception.

BACKGROUND: Hepatitis C virus (HCV) accounts for 15,000 deaths in the United States yearly because people living with HCV are not identified in time to seek treatment, are ineligible for or refuse treatment, or face structural impediments to obtaining treatment such as lack of access to health care or lack of insurance. People who inject drugs (PWID) comprise a large proportion-estimates of up to 60-70%-of current and new HCV infected individuals and face many barriers to completing HCV treatment. METHODS: We conducted 30 qualitative semi-structured interviews of current and former PWID seeking HCV treatment at an opioid-agonist treatment facility in New York City. We used thematic analysis, informed by grounded theory, to examine perceptions of HCV and decisions to initiate HCV treatment. We analyzed the themes that emerged via the common sense model (CSM) of illness perception theoretical framework. RESULTS: Using thematic analyses, two major themes emerged related to engagement in HCV treatment. First, participants independently compared HCV to HIV, and in so doing, emphasized the potential fatality of HCV and the need for treatment. Second, participants described witnessing others suffer or die from untreated HCV and expressed how these recollections impacted their desire to undergo treatment themselves. Together, these themes contributed to the way participants perceived HCV and informed their decisions to initiate treatment. Both themes reflect the CSM's "self-regulation" process, which posits that understanding the causes and consequences of an illness impacts one's ability to seek treatment to overcome this illness state. CONCLUSIONS: This paper offers insight into how clinicians can better understand and utilize HCV illness perceptions to evaluate willingness to engage in HCV treatment among PWID considering antiviral treatment modalities.

Evidence-based interventions to enhance assessment, treatment, and adherence in the chronic Hepatitis C care continuum.

BACKGROUND: With the explosion of newly available direct acting antiviral (DAA) Hepatitis C virus (HCV) treatments that demonstrate 95% sustained virologic response (SVR) rates, evidence-based strategies are urgently needed to achieve real-world effectiveness in challenging patient populations. While HIV is incurable, lessons from over 30 years of experience overcoming obstacles to the HIV treatment cascade could be applied to the HCV context. METHODS: Using Institute of Medicine guidelines, we conducted a systematic review of published interventions from PubMed, Medline, GoogleScholar, EmBASE, and PsychInfo bibliographic databases and citation indices. Abstracts were first screened by three independent reviewers and studies were included if they involved original research, described a specific intervention, were published in English in a peer-reviewed journal between 2001 and 2014, and had full text available. RESULTS: Evidence-based interventions to enhance HCV assessment, treatment, and adherence generally fell into one of 4 categories, including those involving: (1) diagnosis or case-finding; (2) linkage to HCV care; (3) pre-therapeutic evaluation or treatment initiation; or (4) treatment adherence. While most available eligible studies described interventions using non-contemporary interferon-based HCV treatments, future research will need to address how these interventions apply to the context of well-tolerated, simple, oral treatment regimens. In some cases, we explored how HIV-specific interventions might be modified to fit the HCV spectrum of care engagement. CONCLUSIONS: Evidence-based interventions should be strategically incorporated into HCV treatment implementation efforts to most effectively deliver treatment and maximize treatment outcomes.

Models of care for the management of hepatitis C virus among people who inject drugs: one size does not fit all.

One of the major obstacles to hepatitis C virus (HCV) care in people who inject drugs (PWID) is the lack of treatment settings that are suitably adapted for the needs of this vulnerable population. Nevertheless, HCV treatment has been delivered successfully to PWID through various multidisciplinary models such as community-based clinics, substance abuse treatment clinics, and specialized hospital-based clinics. Models may be integrated in primary care--all under one roof in either addiction care units or general practitioner-based models--or can occur in secondary or tertiary care settings. Additional innovative models include directly observed therapy and peer-based models. A high level of acceptance of the individual life circumstances of PWID rather than rigid exclusion criteria will determine the level of success of any model of HCV management. The impact of highly potent and well-tolerated interferon-free HCV treatment regimens will remain negligible as long as access to therapy cannot be expanded to the most affected risk groups.

Social support networks and primary care use by HIV-infected drug users.

HIV-infected current and former drug users utilize primary care and preventive health services at suboptimal rates, but little is known about how social support networks are associated with health services use. We investigated the relationship between social support networks and the use of specific types of health services by HIV-infected drug users receiving methadone maintenance. We found that persons with greater social support, in particular more social network members or more network members aware of their HIV status, were more likely to use primary care services. In contrast, social support networks were not related to emergency room or inpatient hospital use. Interventions that build social support might improve coordinated and continuous health services utilization by HIV-infected persons in outpatient drug treatment.

Effectiveness of a risk screener in identifying hepatitis C virus in a primary care setting.

OBJECTIVES: We evaluated an intervention designed to identify patients at risk for hepatitis C virus (HCV) through a risk screener used by primary care providers. METHODS: A clinical reminder sticker prompted physicians at 3 urban clinics to screen patients for 12 risk factors and order HCV testing if any risks were present. Risk factor data were collected from the sticker; demographic and testing data were extracted from electronic medical records. We used the t test, χ(2) test, and rank-sum test to compare patients who had and had not been screened and developed an analytic model to identify the incremental value of each element of the screener. RESULTS: Among screened patients, 27.8% (n = 902) were identified as having at least 1 risk factor. Of screened patients with risk factors, 55.4% (n = 500) were tested for HCV. Our analysis showed that 7 elements (injection drug use, intranasal drug use, elevated alanine aminotransferase, transfusions before 1992, ≥ 20 lifetime sex partners, maternal HCV, existing liver disease) accounted for all HCV infections identified. CONCLUSIONS: A brief risk screener with a paper-based clinical reminder was effective in increasing HCV testing in a primary care setting.

Primary care-based interventions are associated with increases in hepatitis C virus testing for patients at risk.

BACKGROUND: An estimated 3.2 million persons are chronically infected with the hepatitis C virus (HCV) in the U.S. Effective treatment is available, but approximately 50% of patients are not aware that they are infected. Optimal testing strategies have not been described. METHODS: The Hepatitis C Assessment and Testing Project (HepCAT) was a serial cross-sectional evaluation of two community-based interventions designed to increase HCV testing in urban primary care clinics in comparison with a baseline period. The first intervention (risk-based screener) prompted physicians to order HCV tests based on the presence of HCV-related risks. The second intervention (birth cohort) prompted physicians to order HCV tests on all patients born within a high-prevalence birth cohort (1945-1964). The study was conducted at three primary care clinics in the Bronx, New York. RESULTS: Both interventions were associated with an increased proportion of patients tested for HCV from 6.0% at baseline to 13.1% during the risk-based screener period (P<0.001) and 9.9% during the birth cohort period (P<0.001). CONCLUSIONS: Two simple clinical reminder interventions were associated with significantly increased HCV testing rates. Our findings suggest that HCV screening programs, using either a risk-based or birth cohort strategy, should be adopted in primary care settings so that HCV-infected patients may benefit from antiviral treatment.

Hepatitis C management by addiction medicine physicians: results from a national survey.

Drug users are disproportionately affected by hepatitis C virus (HCV), yet they face barriers to health care that place them at risk for levels of HCV-related care that are lower than those of nondrug users. Substance abuse treatment physicians may treat more HCV-infected persons than other generalist physicians, yet little is known about how such physicians facilitate HCV-related care. We conducted a nationwide survey of American Society of Addiction Medicine physicians (n = 320) to determine substance abuse physicians' HCV-related management practices and to describe factors associated with these practices. We found that substance abuse treatment physicians promote several elements of HCV-related care, including screening for HCV antibodies, recommending vaccinations against hepatitis A and B, and referring patients to subspecialists for HCV treatment. Substance abuse physicians who also provide primary medical or HIV-related care were most likely to facilitate HCV-related care. A significant minority of physicians were either providing HCV antiviral treatment or willing to provide HCV antiviral treatment.