A DNP Nurse-Managed Hepatitis C Clinic, Improving Quality of Life for Those in a Rural

Area

Virginia P. Krebbeks, DNP, APRN, ANP-BC 1

Vivian M Cunningham, PhD, CNM, FNP 2

1
Nurse Practitioner, Raymond Thomas, MD,PC, mamausmc@yahoo.com
2
Assistant Professor of Nursing, St. John Fisher College, vcunningham@sjfc.edu

Abstract

Hepatitis C virus is quickly becoming a national threat, involving 2% of the nation’s population,

ranking this as the 11th most prevalent disease in the world. Traditionally, treatment for hepatitis

C has been conducted in tertiary care settings, limiting access to care for those residing in rural

areas. Improving access to care through the development of a Doctor of Nursing Practice (DNP)

nurse-managed clinic in a rural setting will improve health outcomes and quality of life for those

treated outside the traditional setting. Caring for those living in less densely populated areas

requires an understanding of rural culture. This paper will discuss the development and

implementation of a DNP Model of Care for rural patients being treated for hepatitis C. The

model of care starts with identifying the hepatitis C, treating the patient following established

medical guidelines, using the nursing model to monitor clinical progress and managing side-

effects caused by the treatment medications. Using the DNP Model of Care, a patient-focused

clinic can successfully treat rural patients utilizing the principles of the Effect Theory for

management and the Process Theory for ongoing evaluation. Collaboration with other key

resources, utilizing a multidisciplinary approach allows the DNP nurse to care for those requiring

treatment for chronic hepatitis C, where they live and work with the assistance of family and

social support.

Online Journal of Rural Nursing and Health Care, 13(1) 

Keywords: Hepatitis C, Rural nursing, Nurse-managed clinics

A DNP Nurse-Managed Hepatitis C Clinic, Improving Quality of Life for Those in a Rural

Area

The Institute of Medicine (IOM), Committee on Prevention and Control of Viral Hepatitis

Infections (CPCVHI) considers Hepatitis C (HCV) a major health problem and a major cause of

liver disease (Colvin & Mitchell, 2010). Approximately 4.1-4.9 million people are affected with

HCV in the United States (US), accounting for 1.8-2.0% of the general population (Calvert,

Goldenberg, & Schock, 2005; Moore, Hawley, & Bradley, 2009; Rustgi, 2007) resulting in

8,000-10,000 deaths annually (Wolfe & Stowe, 2007; Albeldawi, Ruiz-Rodriguez, & Carey,

2010). Ranked as the 11th most prevalent disease in the world, (Pozza, 2008), there are 170

million cases of HCV responsible for 1.4 million deaths per year worldwide (Moore et al., 2009;

Pozza, 2008; Rustgi, 2007; Wolfe & Stowe, 2007), but these numbers are difficult to obtain

without a national Hepatitis C surveillance program (Colvin & Mitchell, 2010). These statistics

are expected to triple in the next 10-20 years (Albeldawi et al., 2010), positioning HCV as a

“global epidemic” in the new millennium (Gane, 2008), even as it has been termed the next

“hidden epidemic” (“Hepatitis outbreaks outscore ongoing risk”, 2009).

A recent analysis showed a rapidly increasing number of deaths among HCV-infected

persons, which now surpasses the deaths among HIV-infected persons in the US (Ly et al., 2012,

p. 276). According to this new study from the U.S. Centers for Disease Control and Prevention

(CDC) and Chronic Liver Disease Foundation recommends routine screening among those born

between 1945 and 1965, not just for those at risk to for viral infection (Ly et al., 2012). HCV is

the most common blood-borne infection in the US and is the leading cause of liver transplants

(Albeldawi et al., 2010; Dienstag & McHutchison, 2006; Gane, 2008). The Organ Procurement

Online Journal of Rural Nursing and Health Care, 13(1) 

and Transplantation Network, located in the US, states that 6,320 patients underwent liver

transplantation in 2009 for treatment of end-stage liver failure, with nearly 17,000 patients

currently waiting for a donor liver (Sornmayura, 2010). Approximately 75%-85% of acutely

infected individuals progress to chronic infection with up to 20% developing cirrhosis over 20-

30 years, putting them at risk for end-stage liver disease and hepatocellular carcinoma (HCC)

(Rustgi, 2007; Talley & Martin, 2006) and possible severe quality of life impairment. The risk of

HCC is 1%-4% per year when cirrhosis of the liver has been established (El-Serag, 2012). HCC

is expected to increase in this group over the next decade due to the slow progression of the

disease. HCC is the third leading cause of cancer deaths worldwide, the fifth most common

cancer among men and the eighth most common cancer among women (Sornmayura, 2010).

Antiviral therapy is considered standard of care even when eradication of the virus may not

occur, as it reduces the risk of developing malignancy (Talley & Martin, 2006). Because of

routine screening of blood products since 1992, the number of new HCV cases is declining, but

the rates of HCV associated morbidity and mortality will continue to rise (Rustgi, 2007) for the

next 20-30 years. Though the incidence of acute and chronic hepatitis A and B is diminishing in

this country, and theoretically the eradication of these diseases could occur over the next 20

years through standard vaccination, HCV has multiple types and subspecies with a high rate of

mutation, making vaccine development very difficult. Until a vaccine is developed, reducing the

spread of the HCV needs to be continued though the identification and testing of individuals with

risk factors and public education on acquisition of HCV.

Rural Nursing and Quality of Life

Rural Nursing poses challenges and opportunities for unique care and is different from

urban nursing due to the essential attributes and culture of this population. Rural nursing has

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been identified as provision of health care by professional nurses to persons living in sparsely

populated areas (McCoy, 2009) though these areas are not well defined. Rural can mean country,

agriculture, or refer to attributes of rural culture. Sparsely populated can be defined anywhere

between 3 and 1,000 persons per square mile. The term underserved has been used in association

with rural nursing. Availability, accessibility, acceptability and affordability are all concerns for

the rural nurse (Spencer, Van Dyke, & Swain, 2001). The general educational level of the rural

population can be a challenge for the rural nurse. These factors compounded by a serious,

chronic and potentially deadly virus must be included for the rural nurse’s critical thinking.

“After years of debate about universal health insurance legislation, it has not been enacted,

leaving the most vulnerable members of society which includes the poor, those living in rural

settings and children without comprehensive care” (Russell & Neff-Smith, 2001, p. 81). DNP

nurses working in any setting require a model of care with a theory base by which to practice and

rural nursing is no exception. Once diagnosed with HCV, rural patients may not start treatment

due to inconvenient access to specialist care (Poll, 2009) which is traditionally available in

tertiary care settings located in urban areas. Rural health care providers are expected to do more

with less and accept responsibilities not usually expected of providers in the urban setting.

Health and work beliefs, isolation, distance, outsider/insider concept, self-reliance, and lack of

anonymity or familiarity are concepts identified with the rural community (Long & Weinert,

1998). Lack of health care accessibility is a major factor with the rural patient. Transportation,

distance, isolation, weather, finances, time of year (including planting and harvesting of crops,

and hunting season), attitudes toward health and patient education may be barriers to care all

must be considered before hepatitis treatment is considered (Bryant, Elliott, Hanson, Lobner, &

Thomas, 2001). Seasonal agricultural farm workers who are transient and are of a different

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culture may be included as a subset population. Understanding these concepts of rural nursing

will require the DNP to create an evidence-based plan of care for the HCV patient undergoing

treatment.

Rural areas may have few mental health clinics, thus primary care providers may be the

only source of care. Side effects experienced by patients undergoing treatment may be minimal

or quite severe. The most common reason to discontinue treatment is psychiatric side-effects

such as depression (Hopwood & Treloar, 2005; Treloar & Hopwood, 2008) suicidal and

homicidal thoughts. “Road rage” has been seen in some patients. Identifying the key family

members for support for those experiencing depression during treatment can augment the rural

nurse’s plan of care. The patient’s own coping skills that have been used successfully need to be

utilized. Keeping the primary care provider aware of treatment and psychiatric concerns early in

treatment may avoid disaster from treatment side effects. The DNP nurse should discuss with the

collaborating hepatologist any emerging adverse side effects and discontinue treatment if

necessary.

It is important to remember, that every patient identified with HCV, treated for the virus

and who has successfully achieved a sustained viral response (SVR), reduces the chance of

cirrhosis, HCC and have eliminated the potential spread of that virus to another person. This is

imperative no matter where treatment occurs, thus the availability of a rural clinic with a DNP

managing the HCV treatment can continue to reduce the morbidity and mortality of this virus.

Theoretical Framework

Nursing case management, provided by public health nurses and social workers, has been

in practice since the 1800’s to improve health care to immigrants and those who could not afford

health care. Nursing clinics that include Advanced Practice Nurses frequently offer services to

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those uninsured and underserved that have chronic illnesses. The DNP with advanced

preparation will add diagnostic skills and clinical management to those with chronic illness and

in need of patient-focused care. The Doctor of Nursing Practice Model of Care focuses on the

patient, allowing the DNP to oversee the Hepatitis C treatment while managing response to

treatment and monitoring any side effects to care. The office visits, laboratory monitoring and

documentation by both the patient and managing nurse allow improved compliance and success

rates in treatment. Critical thinking and decision making by the DNP is made with evidence-

based information and a theoretical base. The Effect theory brings together scientific facts and

behaviors to deliver interventions and predict outcomes (Issel, 2009). This theory demonstrates a

relationship between behavioral factors, disease causality, with moderating and mediating

mechanisms, and disease outcomes. The identification of risk factors as described by the model

will allow an accurate testing of possible disease and prediction outcomes (Estes, 2007). The

theoretical framework used to implement this model of care for the treatment of HCV is the

Effect theory, see Figure 1. This combination theory provides the reader with an understanding

of the complexity of HCV in the rural setting and its impact for treatment outcomes. The DNP

nurse practicing in a rural setting can best understand the needs of the HCV patient as this is

where the patient is living and where primary intervention occurs. The DNP may also appreciate

the cultural complexities of the rural setting using this model.

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Figure 1 A Flow Chart showing using the Effect Theory with HCV using a linear chart. Adapted from
Health Program: Planning and Evaluation: A Practical Systematic Approach for Community Health, by
L. M. Issel, 2009, p. 181. Copyright 2010 by the American Psychological Association. Reprinted with
permission. Guidelines for intervention (Ghany, Nelson, Strader, Thomas, & Seeff, 2011; Yee et al.,
2012).

DNP Model of Care for a Rural Clinic

Although traditional treatment for Hepatitis C is carried out in tertiary/hospital settings, a

rural clinic managed by a DNP nurse, working in collaboration with a hepatologist, can

successfully evaluate and manage the multiple complications and side effects commonly seen

with Hepatitis C treatment. Patient-centered availability, access to treatment with cost savings

benefits seen by nurse-managed clinics (Ehsani, Vu, & Karvelas, 2006), allows a rural clinic for

Hepatitis C as an acceptable option for viral treatment. The concerns and challenges of the rural

nurse as discussed above were used to develop the DNP Model of Care. Below (Figure 2.) is the

Online Journal of Rural Nursing and Health Care, 13(1) 

DNP Model of Care developed by the author for those with chronic illness in a rural setting and

used for the patient being treated with HCV. The patient is the focus of care with the DNP

surrounding the outer circle of the model as the manager of the care. Surrounding the patient are

factors that influence treatment outcomes, such as quality of life or completion of treatment, and

failure to eradicate the virus. The accessibility, availability, affordability and acceptability

concerns were used to identify the factors affecting the treatment. In a rural setting these

complicating concerns for the patient will be different than care within an urban setting, thus it is

necessary to incorporate these factors into the surrounding boxes. These individual factors may

complicate treatment and thus need to be monitored and managed by the DNP.

© 2011 Krebbeks

Figure 2 Doctor of Nursing Practice Model of Care.

Online Journal of Rural Nursing and Health Care, 13(1) 

 A mission statement needs to be made for any clinic development. This should state the

purpose of the clinic, how it will be developed and how it will be evaluated (Issel, 2009).

Clinical Objectives will need to be established for a DNP managed HCV clinic.

These include to:

• increase awareness for the prevention of HCV to prevent new infections

• target lifestyle changes needed with HCV treatment

• improve access to HCV treatment

• provide services to those uninsured and underinsured

• provide a shorter time from diagnosis to treatment

• reduce the impact on health costs for treatment

• prevent the complications for cirrhosis associated with HCV

• obtain a sustained virological response early in treatment and 6 months following

completion of treatment

Once the mission statement and objectives for the clinic have been established,

implementing the plan of care for the patient with HCV will be followed using the guidelines of

the model of care and the theoretical framework which is consistent with the program purpose

and objectives. The patient is referred to the clinic from their primary care provider, OB/GYN, a

Red Cross or similar blood donating organization or from recent incarceration. On the first visit,

the patient enters the clinic with a definite diagnosis for HCV or may be referred to the clinic

with abnormal liver function tests. The DNP will either establish the diagnosis of HCV or

confirm the presence of chronic active HCV through the identification of active virus with a

RNA quantitative viral load and genotyping of the virus. Supplemental baseline laboratory

testing is done at this first visit. These tests include a CBC, HAV and HBV antibody levels,

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chemistries, autoimmune indices, and a ferritin level, TSH, HIV and HCG for female patients

and for female partners of male patients if they are of child-bearing age. An abdominal

ultrasound is obtained on all patients to observe the contour of the liver. This may give the DNP

an indication if cirrhosis is already present. If any question exists, then an ultrasound guided liver

biopsy may be obtained, but mandatory liver biopsy is no longer necessary prior to treatment

(Nazareth, Piercy, Tibbet, & Cheng, 2008). A baseline EKG is recommended (Yee et al., 2010).

An informational packet that may be provided by the manufacturer of the treatment

medication(s), is given to the patient at this first visit. These packets contain information on the

treatment drugs including how they are to be taken with possible side effects and cautions

regarding their use. These drugs have a “black box warning”, meaning they may have dangerous

side effects under certain circumstances. It is important not to overwhelm the patient at this point

as they have received an extreme amount of information on this first visit. Allowing an hour of

time for this visit is not unusual.

The second visit is about 2-3 weeks later, allowing the results of all testing done to this

point to return to the provider. The DNP will review all the previous testing including the result

of the viral quantitative count. If confirmation of HCV is determined with a positive presence of

virus, then a more detailed discussion regarding the treatment is made. The patient is given a

journal for recording laboratory results, documenting exercise/physical activity done during

treatment (McKenna & Blake, 2007), and any questions or concerns they may have throughout

their time of care. A patient/provider contract for treatment is reviewed and signed by both

parties. This contract contains patient and provider responsibilities, including appointment visits,

laboratory times, and the importance abstinence of alcohol and non-prescribed drugs. Of

significant importance is the understanding of not becoming pregnant or impregnating anyone

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else during treatment or for 6 months following treatment, as treatment drugs for HCV have been

determined to be teratogenic. An educational review of the medication side effects should be

documented in the contract.

A dilated fundoscopic eye exam is important at the beginning of treatment to determine any

baseline abnormalities, as some visual difficulties can but rarely occur as a result of the treatment

drugs. These visual difficulties usually subside after treatment completion. Subsequent exams

during treatment are at the discretion of the ophthalmologist performing the initial exam, and it is

important to follow-up any finding of fundoscopic cotton-wool exudates. Retinopathy is

common with pegylated interferon, one of the treatment medications, but most events that may

occur clear after treatment is completed (Mehta, 2010).

An influenza immunization is recommended during the season and vaccination for HAV

and HBV are important if the patient has not had established immunity. Avoiding exposure to

influenza and other viruses during treatment may be difficult. It is contraindicated to immunize

patients with live virus while undergoing treatment for HCV.

Regular office visits occur at 1,2,4,6,8,12 and every 4 weeks thereafter until treatment is

completed. Laboratory testing is obtained at these times to assure no serious consequences are

occurring. Calculating and documenting serial absolute neutrophil counts (ANC) is important

when monitoring for serious side effects. Following medical protocol regarding these values is

essential. It is important to obtain a quantitative viral load at weeks 2, 4,12,24,36, and 48, then 1,

3, and 6 months post-treatment. Testing yearly thereafter has not been established. The patient is

weighed at each visit to monitor any loss. Some weight loss is expected but should not be

excessive (Suwantarat, Tice, Khawcharoenporn, & Chow, 2010).

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Treatment and Screening for Hepatitis C

The standard treatment of care for HCV is well-documented by the American

Gastroenterological Association (AGA), American Association for the Study of Liver Diseases

(AASLD) and the American College of Gastroenterology (ACG), (Dienstag & McHutchison,

2006; Gane, 2008; Ghany, Nelson, Strader, Thomas, & Seeff, 2011, & Yee et al., 2012) which

needs to be followed by the DNP. Any deviation from those protocols needs to be discussed and

documented with the collaborating physician.

It is important for the patient to know how to self-administer these medications,

especially those requiring subcutaneous injection. The start of treatment begins in the clinic

office. The DNP or clinic nurse demonstrates to the patient how to administer the medications

with an emphasis on technique and hygiene. Safe disposal of the used needles and syringes is

essential for safety of the patient and any household members.

The cost of treatment with pegylated interferon and ribavirin is very high, about $30,000

per patient for the medication alone (Calvert et al., 2005). The National Surveillance Program

calculated the cost of screening for HCV to be $1,246 per case detected, though other studies

have shown the cost between $374 and $1,047 per case detected (Albeldawi et al., 2010). HCV

screening and early treatment has the potential to improve average life-expectancy but in the past

focused only on those at high risk for the virus (Sroczynski et al., 2009). With new concerns

regarding the testing of all “baby boomers”, the diagnosis of those with chronic HCV will rise.

Approximately 30% of patients identified with chronic HCV have normal liver tests but upon

liver biopsy, have some degree of liver damage, thus it remains very important to screen for

those with current or past risk behavior for the virus (Sornmayura, 2010).

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 The treatment for HCV changed May 2011 with the addition of protease inhibitors for the

treatment for genotype 1. These additional medications have made a significant increase in the

eradication rate of the HCV but treatment complications have increased (Stauber & Kessler,

2008). The identification of genetic variations with response to treatment may also influence

viral eradication (Ge et al., 2009), but the use of genetic testing to determine treatment eligibility

is controversial. The large tertiary clinics should be able to incorporate these treatment changes

with little difficulty, but rural areas may find resources and funding difficult to manage. Despite

this, the management of HCV treatment in a rural setting should be reasonable with a workable

model of care and collaborating health team.

Evaluation Plan

Evaluating this model of nursing care needs to include both quantitative and qualitative

outcomes. Mentioned previously are quality of life concerns regarding HCV. Observation by the

DNP during office visits, conversation with patients and families with review of journal entries

are all forms of qualitative measurements. Quantitative measurements may include compliance

with office appointments, medication adherence and successful eradication of the virus at

completion of the treatment contract. Some of these measurements can be seen through the

monitoring of laboratory values and their expected changes, the measurable depletion of given

medication, and lack of unacceptable behavior and legal involvement.

Clinical office conferences with the possible presence of collaborators involved in those

patients undergoing HCV treatment will be essential for the success of the clinic. Effective

leadership by the DNP manager will require a strong support staff with those wanting to make a

difference in care delivery, the creation of ideas and actions, creativity with energetic and

committed followers (Bethel, 1990). This author advocates a “circle network” that allows and

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encourages information to move from one member to another equally. Communication is

simplified and members have easy access to other member’s thoughts (Bolman & Deal, 2008)

with team members sharing responsibility for achieving the common goals of the clinic (Freund,

& Drach-Zahavy, 2007). Familiarity among clinic staff members is also important for the

patients. With a small group in a rural setting, this management structure should be effective.

A program evaluation plan must include operating costs of the clinic, with one method

being a break-even analysis tool. This mathematical calculation divides the fixed cost of

operation of the clinic into the cost per patient equaling the number of patients needed to be seen

(Issel, 2009). This analysis should be done before the opening of the clinic, early in its operation

and throughout its management. Unfortunately, lack of health insurance can be a critical factor in

treating this potentially vulnerable population. Medicare and Medicaid can underestimate actual

costs for providing services which can greatly affect operational costs. It is essential for patients

without health insurance to apply for financial assistance for both their advantage and for the

security of the clinic. A bill, H.R. 2754, to amend the Public Health Service Act to establish “the

Nurse-Managed Health Clinic Investment Program”, was at one time a possible option for those

wanting to start and independent rural clinic (Capps, 2011) but unfortunately the bill did not

become a law, although it may be offered at some future point. Another solution is to incorporate

the nurse-managed clinic into an existing gastroenterology or primary care practice to help

defray the costs. Sharing of office equipment and staff with the DNP providing care to those with

HCV along with patients with other health problems may need to be done until the clinic is

financially secure. A third method to provide cost-effective care is the use of telemedicine. Its

use in rural and prison settings allows providers to effectively manage patients with chronic

illness (Arora, Thornton, Jenkusky, Paris, & Scalletti, 2007). The Process theory showing the

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components of the organizational and service plans may be used for a nurse-managed clinic as

shown below (figure 3).

Conclusion

As health care becomes more complex, evidence-based practice with collaboration

among multiple health disciplines needs to be implemented. Cost effective care with positive

outcomes and individualized care with innovation will be necessary. The IOM suggests

knowledge about this disease is poor (Colvin & Mitchell, 2010) and significant stigma surrounds

this diagnosis (Butt, Paterson, & McGuinness, 2008). With an accepted and useful model of care

and theoretical framework with an ongoing evaluation tool, a Hepatitis C clinic within a rural

setting can be successfully managed by a DNP prepared nurse. Using the Effect and Process

theory, with the DNP Model of Care, patients with HCV can be provided quality, culturally

sensitive and cost-effective care. With the Institute of Medicine’s concern regarding the spread

of HCV, rising death rates for those with HCV, the recent statement by the CDC regarding

testing for the vulnerable age group, and Healthy People 2020 (U.S. Department of Health and

Human Services, Office of Disease Prevention and Health Promotion, n.d.) including

communicable disease a national concern, a DNP nurse-managed clinic can fill the gap and meet

the need for addressing this “global epidemic”.

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 Organizational Plan Input
Outputs

Human Resources
DNP Informational System
Medicial Technician M o n t h l y / We e k l y
Receptionist reports of intake and
Collaborating MD outputs

Informational Budget
resources Break-even analysis
Software for EMR

(existing)
Educational handouts/
patient journals
Time line
establish estimated
Monetary Resources start date of clinic
Grant application (if
necessary)
Organizational chart
Circle Network
Physical Resources
pre-existing office, DNP/MD
needing two exam MT/Receptionist
rooms and reception (Bolman & Deal, 2008
area p. 106)

Transportation
resources
Private car, county Operational Manual
area transport bus, Office Protocol
VA M C t r a n s p o r t ,
county medicaid cab office visit frequency,
vital signs, flow chart,
patient journal, etc.
Managerial Resources
DNP clinical manager

Time Resources
1 and 2 year cycles

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 Services Utilization plan inputs
Outputs

Participants
Those patients with positive Coverage
HCV antibody or active HCV Health ins
virus requiring treatment or
private pay, sliding fees
monitoring of virus
Indigent coverage from drug
company

Queuing
Increasing testing for HCV virus Units of Service
Info for PCP's Frequency of lab testing
Decrease wait list time to 2 weeks Number of visits
and start of treatment
Length of Treatment

Intervention Delivery
Materials Produced
Treatment of HCV virus with the
guidelines established by Ghany et Number of Patients in Clinic
al., 2011; Yee et al., 2012 Those continued and completed
Collaborate with MD for updates treatment
and treatment response changes Number of patients with sustained
viral response (SVR)

Social Marketing
Product-treatment Work Flow
Price-insurance coverage # of patients seen
Place-office Need for regular staff meetings
Promotion-posters, public speaking Staff education

Figure 3: The Process Theory. Flow chart showing how a logic model as a tool for program evaluation
may be used for HCV. Adapted from Health Program Planning and Evaluation: A Practical Systematic
Approach for Community Health, by Issel 2009, p. 276. Copyright 2010 by the American Psychological
Association. Reprinted with permission.

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 Acknowledgement

Raymond M. Thomas, MD

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