| The
Team Approach to
Drug regimens for treating HCV infection are not easy for patients to complete. Most patients experience side effects, and nonadherence is not uncommon. However, adherence to the prescribed regimen is crucial to the success of the treatment plan, so the treatment team must take an aggressive approach to helping patients follow their treatment regimen.
The management of HCV therapy is greatly aided by the involvement of physician assistants or nurse practitioners. Other professionals who are involved to varying degrees include dieticians, social workers, mental health professionals, pharmacists, and other specialist physicians who are called upon as needed. To be successful, the team approach requires communication and mutual respect among all team members as well as a clear understanding of each member's roles and responsibilities. Physician assistants and nurse practitioners are licensed to perform many aspects of the management of hepatitis, including ordering and interpreting tests and prescribing medications. In some states, nurse practitioners participate in end-stage liver disease clinics, and they serve as pre- and post-transplant coordinators. Likewise, physician assistants in some states perform liver biopsies.
The medical team approach extends, of course, to the patient (Figure 12). Active engagement of patients with medical team members can establish a camaraderie among all parties and should reassure patients that they are not alone as they cope with their disease. The medical team must make clear from the outset that the patient is not a passive bystander in the management of his or her disease. Patients are expected to assume personal responsibility for their care. They must keep their appointments, attend training and educational classes, and take their medications as prescribed. Just as important, they must communicate and let the medical team know when they are experiencing side effects or any other problems. Many institutions ask their patients to sign contracts. Such a contract is a statement of understanding that spells out the plan of action and specifies the roles and responsibilities of both the patient and the members of the medical team. Contracts must be written in simple and understandable prose. When necessary, patients should be reminded that they have signed a contract. Patients are
responsible for understanding and maintaining their insurance coverage.
The remainder of this section of the monograph outlines a model for the effective marshaling of resources that some centers have found helpful for managing patients with hepatitis C. The model presents a way for centers to organize their practices to better and more efficiently take advantage of the team approach to HCV management. The model calls for a case manager to be in charge of all the counseling and educational tasks described here; for the purposes of this monograph, the nurse practitioner serves as the case manager. It is important to note that this model will be applicable only to those HCV-infected patients who are appropriate candidates for IFN-based therapy. Most patients with HCV infection do not prove to be candidates for IFN-based therapy, owing to failure to show up for appointments or tests, severe medical or psychiatric comorbidities, ongoing substance abuse, or other factors.225 Following diagnosis,
only patients deemed to be stable enough to undergo anti-HCV therapy
are referred by the physician to the nurse practitioner's counseling
sessions, and these sessions involve at least three separate interactions
over at least a 3-month period, which provides further opportunities
to identify patients without the stability or commitment to undergo
therapy.
Despite the central role of the nurse practitioner in this model, it is the physician who first interacts with the patient following diagnosis and who directs the overall treatment plan. Because of the complexity and chronicity of HCV infection, its management generally requires a heightened degree of trust and comfort between patient and physician. Successful management of HCV infection demands that physicians draw upon their very best patient interaction skills, such as active listening, empathy, collaborative decision-making, education, and reassurance. At the time of diagnosis, after explaining the benefits and risks of treatment, the physician develops a proposed treatment plan together with the patient. At that point, the patient is referred to the nurse practitioner, who will build upon the physician's initial counseling to prepare the patient for the formidable challenges posed by HCV infection and its treatment. This preparation consists of both education and support, and should be provided to both the patient and his or her family. The more education and coping tools that patients and their families are exposed to up front, the fewer calls that physicians and nurses will field later in the course of management. At the first office counseling session, the nurse practitioner and the patient should formulate the schedule that the patient will follow for the next year or so. This schedule includes one-on-one visits during appointments for injections, reviewing blood tests, and managing side effects, as well as group counseling and education sessions. Patient education and support should be targeted at three broad categories of patients' needs, as outlined below. Clinical education. Women of childbearing age should be warned at the first visit that they must practice double-barrier contraception during the entire treatment course and for 6 months thereafter. If a patient does become pregnant, treatment must be discontinued immediately, and the patient's obstetrician should be consulted. The risk of birth defects should be explained, and abortion services should be thoroughly discussed. The natural history of HCV infection and its symptoms (both current and anticipated) should be explained in language that is appropriate and understandable to the patient. The patient's suspected means of contracting HCV should be identified, and the risks of HCV transmission should be explained. Both patients and their families should be reassured that HCV transmission is virtually always via blood-to-blood contact (Table 16) and that the risk of transmission through routine household contact is extremely low.
Management of side effects should begin before the first dose is administered. Therapy for chronic HCV infection is long-term, and patients may not fully appreciate the commitment they must make to improve their health. It is our duty to educate them. Patients are generally hardest hit by side effects after their first dose. Adequately preparing patients for this eventuality should decrease their anxiety when the side effects do occur. Patients who are informed about how to manage their side effects are less likely to discontinue therapy or to seek emergency care. (Side effects are discussed in greater detail later in this section.) Emotional/psychological support. Patients newly diagnosed with chronic disease generally go through a range of emotional stages, including denial, anger, depression, and acceptance. At the first office counseling session, the nurse practitioner should make it clear that emotional upheavals are normal and that patients can maximize their chance for a good outcome by accepting their disease, taking control, and developing a positive attitude toward achieving a good outcome. Education, encouragement, and support from both the medical team and the patient's family and friends are crucial to helping patients maintain a positive attitude. Patients should be encouraged to continue their normal lifestyle during therapy, including working, socializing, and fulfilling their family roles. Once the nurse practitioner determines that the patient is in a proper frame of mind, the two of them can collaborate in scheduling group counseling sessions in addition to their regular one-on-one sessions. Social support and employment issues. It is important to determine early on what degree of social support a patient has. Involvement of family and friends is key to helping a patient adjust to the diagnosis and persevere through therapy, and including a family member in education and counseling sessions will facilitate this. For many patients, however, the health care provider may be the primary source of support. The nurse practitioner
should be sensitive to social stigmas that the patient may face
as a result of HCV infection; honest and accurate information should
be presented to the patient and family members to address such stigmas
and help them talk about the disease. HCV infection
and its treatment can put an extreme financial burden on patients
and their families. Managing work issues can be a particular challenge.
The nurse practitioner should be prepared to inform patients, as
necessary, of federal and state laws that can protect their job
security, such as the Family and Medical Leave Act and the Americans
with Disabilities Act (ADA). To claim protection under the ADA,
a patient must still be able to perform the essential functions
of his or her job. The nurse practitioner may be able to help the
patient develop a plan with his or her employer to allow for continued
employment during therapy without disrupting the business. At the
same time, the need to resort to legal remedies to protect against
HCV-related job discrimination is infrequent, and most patients
should be encouraged to stop therapy if its side effects are so
severe as to prevent them from working.
Small-group educational seminars provide an excellent and cost-effective means of putting patients-typically 5 or 6 per session- on the right track. Patients are strongly encouraged to bring a companion with them—someone who is willing and able to help them throughout the treatment course. Some patients bring their Alcoholics Anonymous sponsor. The initial group session typically lasts at least 1.5 to 2 hours. At this session, the nurse practitioner explains exactly what each patient can expect throughout the course of treatment. Drug therapy, side effects, laboratory tests, duration of therapy, and response to therapy are all covered. Patients are also given information prepared by other sources. Pharmaceutical companies provide a wealth of educational resources, including pamphlets, newsletters, websites, and telephone support lines. Information is also provided by the American Liver Foundation, the Hepatitis Foundation International, the NIH, and the CDC. Of course, educational materials should be selected carefully to avoid overwhelming the patient with information overload. Subsequent group sessions are held once or twice a month for 1 hour each. These sessions function more as support meetings, and each patient may attend these according to his or her needs and the focus of each particular session. At these sessions, patients are encouraged to discuss their progress, share their experiences, and ask questions. Guest speakers can add variety to these sessions. Patients should also be instructed to call the office between sessions if they find it necessary. Group sessions offer a number of advantages. First, they serve as a powerful support mechanism for patients, providing camaraderie and a sense that they are not alone in their disease. This tends to encourage treatment adherence and continuation. Second, they are an efficient way of using limited resources, enabling a degree of patient education and counseling that would not be affordable on an individual basis. Moreover, these sessions are reimbursable for the nurse practitioner's time, and even for a physician's time if the physician is needed to answer questions during a portion of the session. From our experience,
centers that conduct group sessions report virtually no patient
objections to taking part in group counseling. One potential barrier,
privacy concerns, can be overcome by having patients sign a Health
Insurance Portability and Accountability Act (HIPAA) consent form
that is specific to participation in the group sessions. For non-English-speaking
patients, one-on-one sessions with an interpreter will generally
have to take the place of group sessions.
An individual counseling session should be held every time the patient visits the office during treatment. Each should last approximately 15 or 20 minutes. At each session, the nurse practitioner should discuss the patient's clinical and emotional progress. The patient also should complete a quality-of-life questionnaire at every visit, and the nurse practitioner should track the scores from month to month to look for trends that should be addressed. Depending on the patient's emotional status, it is sometimes helpful to have a relative or close friend sit in on an individual session. A companion can often offer insight that the patient cannot. These counseling sessions are reimbursable, and they are much more cost-effective than a similar session conducted by a physician. If all is going well, physicians generally see the patient only at weeks 12, 24, and 48 of treatment. Two critical
aspects of these one-on-one visits are discussions of side effects
and adherence to the treatment regimen.
As mentioned, patients should be told in advance what side effects to expect and how to deal with them. Patients must also be continually reminded to report all side effects and other adverse events to the nurse practitioner. The degree of side effects usually varies from mild to moderate, and they are most intense during the first month of therapy. Interferon. As detailed earlier in the monograph, side effects of IFN include flu-like symptoms, some neuropsychiatric disorders (eg, depression and mood lability), alopecia, thyroiditis, nausea, diarrhea, injection-site reactions, neutropenia, anemia, and thrombocytopenia. PEG-IFNs induce neutropenia to a greater degree than do standard IFNs, and neutropenia is the most common reason why patients do not adhere to PEG-IFN regimens. Adjunctive therapy with a granulocyte colony-stimulating factor such as filgrastim will increase neutrophil counts and decrease the risk of infectious complications. Thrombocytopenia does not usually interfere with adherence. Ribavirin. Side effects of ribavirin include hemolytic anemia, birth defects, cough, dyspnea, rash, pruritus, insomnia, and anorexia. Anemia causes fatigue and sometimes alters the patient's ability to function normally. Adding therapy with an erythropoietic growth factor to elevate hemoglobin levels should increase the patient's energy, improve quality of life, and allow for higher doses of ribavirin to continue. However, we have no reliable data as to when hematopoietic growth factors should be administered. Some other side effects can be self-managed and ameliorated by simple interventions such as good hydration, altering doses according to work activities, using analgesics and antipyretics, and exercising regularly.
Management of side effects is key to ensuring that patients adhere to their regimen, and adherence is the most important factor in achieving a good outcome. We prefer the term adherence to compliance, since adherence connotes that the patient is an active partner in treatment rather than merely the obedient subject of a medical experiment. At every encounter, the nurse practitioner should encourage patients to adhere to treatment and praise them when they do. Involving family members is another way to improve adherence. In addition
to side effects, other factors that can hamper adherence are the
seriousness of the illness, the cost and complexity of treatment,
a poor understanding of the disease management process, and the
long duration of treatment. Some of these obstacles can be overcome,
or at least mitigated, by individualizing and altering the regimen
when appropriate, by creatively revising patient contracts, by offering
rewards, and by instituting other patient-centered strategies.
Some pharmaceutical companies have established drug-assistance programs to help patients with the financial burden of therapy, and these are excellent programs. Likewise, specialty pharmacies have designed programs to promote all facets of care and to offer support to patients, their families, and their caregivers. These programs encourage cost-effective approaches to care. Some of these programs offer information on insurance coverage, in-home instruction on self-injection, telephone counseling, and/or home delivery of drugs and supplies, all at no out-of-pocket cost to the patient. The program bills the patient's insurer directly.
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