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CATIE

Hepatitis C virus (HCV) infects and injures the liver and in many cases becomes a chronic infection. Over time, HCV slowly degrades the liver. Eventually, serious bacterial infections, kidney dysfunction, internal bleeding and other complications can develop as the liver deteriorates. Also, the risk of liver cancer is greatly increased.

Most new cases of HCV infection in high-income countries happen among people who share equipment for injecting or inhaling street drugs.

In New York City

Researchers with the New York Department of Health and Mental Hygiene have been trying to find ways to increase awareness of HCV and testing for it among people at high risk for this infection.

According to the researchers, “Chronic HCV infection is commonly associated with persons who are marginalized in the healthcare system, with injection drug use as the primary risk factor. [Also] patients with socio-behavioural and other conditions/issues such as homelessness, psychiatric illness and HIV co-infection have historically been classified as difficult-to-treat and have required increased support to access HCV care.”

Enter the navigator

The term patient navigator refers to a person who works for a health system, usually based in a hospital or large clinic, who helps people with serious chronic or catastrophic illness engage with and move through the many steps in a continuum of care (from diagnosis through treatment).

Specifically, patient navigators are used to enhance the ability of patients to enter into care, understand complex medical information, keep appointments, cope with the stress of illness, access health insurance and/or subsidies for medications, take their medications exactly as prescribed and directed, and keep in touch with the clinic over the medium- and long-term. By doing all of these things, patient navigators can improve health outcomes and address what the researchers have described as “patient- and systems-level barriers to care and treatment.” Studies have found that the services and support provided by patient navigators have played an important role in improving the health of some people with cancer and others with HIV infection.

Check Hep C in New York City

In 2012, the Department, with funding from the private sector, implemented a one-year demonstration project with the patient navigator program Check Hep C. That program helped to screen 4,751 people for HCV and linked 85% of infected people to a clinic. However, researchers with the program noted that only six of the participants who made a visit to a clinic to be medically assessed, were “known to have successfully completed treatment.”

Focusing the role of patient navigators

The Department gained much experience from the program’s first year and received additional private sector funding, which enabled it to modify the program. In the second year, the Department refined the program so that it focused on “supporting persons diagnosed with chronic HCV infection to complete a medical evaluation, access and initiate treatment, and achieve [a cure].”

In its second year of operation (in 2014), the modified program, through its patient navigators, helped to provide the following:

  • an HCV risk assessment
  • health education
  • treatment readiness
  • medication adherence counselling
  • medication coordination with pharmacies and insurance coverage

This time the program enrolled 388 participants. Of these, 129 people (33%) initiated HCV treatment, and 119 (91%) of them were cured. According to the researchers, “Check Hep C successfully supported high-need participants through HCV care and treatment,” resulting in high cure rates.

More about Check Hep C

The revised patient navigator program was implemented at four community-based organizations in New York City:

  • two of the organizations provided on-site care, harm reduction and social services
  • two of the organizations were engaged in harm reduction and needle and syringe programs and referred participants off-site for clinical care

All four sites were located in neighbourhoods where HCV infection was relatively common.

Once participants were in the program, doctors and/or nurses assessed each one for “clinical and psychological factors” in order to make a decision about eligibility for treatment.

The role of the patient navigator

Treatment-eligible participants were contacted by patient navigators and received the following services:

  • accompanied visits (if needed) to healthcare appointments
  • alcohol counselling
  • health education
  • motivational interviewing (a technique to help people change unhealthy behaviours and resolve ambivalence, often used with people who have problematic substance use)

According to the researchers, “Patient navigators supported participants through medical evaluation, preparation for antiviral treatment and treatment adherence.” Furthermore, the patient navigators helped participants connect to the complex and sometimes cumbersome aspects of access to subsidized healthcare and medications in the U.S. Due to the high cost of modern HCV treatment, some health insurance systems have imposed restrictions on medication access—in other words, they are rationing treatment.

Focus on participants

For the purposes of their analysis, the researchers designated participants with no or only one “sociobehavioural or mental health condition as low need, and those with two or more sociobehavioural or mental health conditions as high need.”

Data on participants in the program were assessed between April 2014 and January 2015.

The average profile of 388 participants upon entering the study was as follows:

  • age – 52 years (60% of participants were classed as “baby boomers,” born in the period from 1945 to 1965)
  • gender – 73% men, 26% women and 0.8% transgender
  • injected street drugs in the past year – 29%

Out of the 388 people who entered the Check Hep C program, 77% (299 people) visited clinics to undergo medical evaluation. Among the people who sought such an evaluation, 79% were judged to be treatment eligible.

According to researchers, the chief reasons that participants were not eligible for treatment were as follows:

  • they were engaged in “active drug use”
  • they had other co-existing health conditions that were competing for their attention and time
  • alcohol use

Results

According to the researchers, “Over half (55%) of treatment-eligible candidates initiated treatment during the program period, and of these, 93% completed treatment and 91% [were cured].” They also said that such high rates of cure suggest that patient navigational services are “successful at overcoming previously observed barriers to cure among HCV-infected individuals.”

On-site versus off-site

Participants who were in a study location/clinic that also provided clinical care (these were called “on-site” by the researchers) were twice as likely to be designated “treatment-eligible” by doctors and nurses than patients who were enrolled at other sites that could only refer people elsewhere (called “off-site” by the researchers) for medical care.

Furthermore, participants who were treated on-site were twice as likely to be cured compared to those who received care off-site.

Why did this difference between on-site and off-site treatment outcomes occur? The researchers said that doctors and nurses might be more willing to treat “high-need” people “who are supported through treatment by a patient navigator who is also located at the same clinical site.”

Overcoming barriers

The researchers noted that “treatment ineligibility caused by current alcohol use and active or recent [injection of street drugs] remains a barrier to HCV treatment.” They found that “these sociobehavioural conditions, coupled with other [co-existing health issues], were reported by patient navigators as the most common reasons that clinical providers did not treat otherwise eligible patients.” To manage these issues, the researchers proposed the following interventions:

Patient navigators

“Further training on how to support medical care for people who [are using alcohol and/or substances and who also have common health conditions] such as diabetes, renal disease and mental heath conditions.”

Doctors, nurses and nurse practitioners

“Education and training on updated HCV treatment guidelines and on managing complex cases.”

Patient navigators, now and for the future

According to the researchers, “Patient navigation services delivered through Check Hep C successfully engaged patients in HCV medical care and supported patients who initiated HCV treatment through to cure. The patient navigation strategies can be used in clinics and community-based healthcare organizations serving high-need populations to support HCV treatment and cure. Clinic-based patient navigation services in particular can be used to improve the HCV continuum of care. The success of programs like Check Hep C can be used to support policy changes that ensure the availability of funding or insurance reimbursement for HCV-specific patient navigation and care coordination services. Sustainable patient navigator services for HCV infection are essential to improve clinical outcomes in high-need persons and to end the HCV epidemic.”

Resources

CATIE's hepatitis C information

Health Navigation: A Review of the EvidencePrevention in Focus

 —Sean R. Hosein

REFERENCES:

  1. Ford MM, Johnson N, Desai P, et al. From Care to cure: Demonstrating a model of clinical patient navigation for hepatitis C care and treatment in high-need patients. Clinical Infectious Diseases. 2017; in press.
  2. Falade-Nwulia O, Mehta SH, Lasola J, et al. Public health clinic-based hepatitis C testing and linkage to care in Baltimore. Journal of Viral Hepatitis. 2016 May;23(5):366–74.
  3. Falk D, Cubbin C, Jones B, et al. Increasing breast and cervical cancer screening in rural and border Texas with Friend to Friend plus patient navigation. Journal of Cancer Education. 2017; in press.
  4. Whitley EM, Raich PC, Dudley DJ, et al. Relation of comorbidities and patient navigation with the time to diagnostic resolution after abnormal cancer screening. Cancer. 2017; in press.
  5. Stitzer M, Calsyn D, Matheson T, et al. Development of a multi-target contingency management intervention for HIV positive substance users. Journal of Substance Abuse Treatment. 2017 Jan;72:66–71.
  6. Loskutova NY, Tsai AG, Fisher EB, et al. Patient navigators connecting patients to community resources to improve diabetes outcomes. Journal of the American Board of Family Medicine. 2016 Jan-Feb;29(1):78-89.