PATIENT NAVIGATION

Historical Evolution of Patient Navigation in Cancer Care

The prevention, diagnosis, and treatment of cancer are complex processes that often require consultation with multiple medical specialists in multiple settings, utilizing numerous medical tests.²¹ To understand the unique challenges faced by disadvantaged populations in accessing these complex processes, the ACS conducted a series of hearings in 1989 with low-income Americans throughout the United States. The results of these hearings were published in a report by the ACS entitled Report to the Nation: Cancer in the Poor.⁶ It found that poor people face significant “obstacles” to accessing cancer care services which prevent them from obtaining needed care, including: (1) widespread financial barriers, such as being unable to afford health insurance; Medicaid or Medicare ineligibility; losing employment that provides health insurance; and lack of affordable cancer services; (2) logistical barriers, such as a lack of transportation, living at a far geographic distance from health care, lack of reminder systems, and lack of understandable cancer information; and (3) sociocultural barriers, such as limited social support and inadequate health literacy.

In response to the results of the ACS report, Dr. Harold P. Freeman partnered with the ACS to create the first patient navigation program in Harlem, New York in 1990 targeting women with historically poor breast cancer outcomes.^21-23 This innovative program assisted low-income women in overcoming barriers to breast cancer screening and follow-up care. In addition to expanding screening and education services throughout the community, specified members of the community provided patient navigation services to women with a clinical finding suspicious for cancer.²³

Since the pioneering work of Dr. Freeman, there has been a growing commitment to support patient navigation services. In 2001, the President’s Cancer Panel recommended that funding be provided to support community-based programs, such as patient navigator programs, to assist people in obtaining “cancer information, screening, treatment, and supportive services.”²⁴ As a result, there has been an expansion in programs nationwide, with funding from private foundations, including the ACS, the Avon Foundation, and the Susan B. Komen Breast Cancer Foundation,¹⁹ as well as local government, state government, federal government, and community organizations. In 2003, there were over 200 cancer care programs nationwide providing patient navigation as identified by the NCI.¹⁹ By 2007, the ACS funded more than 60 patient navigation programs across the United States.²⁵

The federal government has made a substantial commitment to patient navigation through support of three separate programs. In 2005, NCI’s Center to Reduce Cancer Health Disparities (CRCHD) funded eight sites for the PNRP (and in collaboration with the ACS, a ninth site joined the PNRP). This program will test community-based navigation programs using a control group. In June 2005, the Patient Navigator, Outreach, and Chronic Disease Prevention Act of 2005 authorized federal grants to hire and train patient navigators to assist patients with cancer and other serious chronic diseases to obtain access to timely diagnostic, treatment, and follow-up care,²¹ and $2.9 million was appropriated in 2007 for this initiative. In 2006, the Center for Medicare Services (CMS) funded six demonstration sites for pilot programs targeting minority Medicare beneficiaries with the goal of overcoming barriers in screening, diagnosis, and treatment of cancer.²⁶ Despite the interest in patient navigation and funding of these programs, there is limited published information regarding their efficacy and cost-effectiveness.

Study Identification

The goal of the literature review was to identify and summarize both descriptive and efficacy literature on patient navigation. A review of research literature in the National Library of Medicine was conducted in October 2007 by searching the PubMed database to identify articles describing patient navigation programs that were published at any time in English with human participants. Reference lists of identified articles were also reviewed for relevant publications. The inclusion criteria specified: (1) published original articles; and (2) a description of a patient navigator program related to cancer treatment, diagnosis, or screening. The PubMed database was searched using the keywords “navigator” or “navigation” and “cancer.” The search produced 893 citations, however, when abstracts of each article were reviewed only 35 were related to cancer patient navigation.^23,27-60 An additional seven studies were found in reference lists of articles identified in the search or were included in the same journal issue as another published paper.^{19,21-22,61-64} Three additional articles were identified by study authors.^65-67 All forty-five articles were reviewed, and any article that described a patient navigator program was retained for further analysis. Twenty-eight articles provided descriptive information on cancer patient navigator programs in sites across the United States and Canada. Of these articles, sixteen provided information on outcomes of a patient navigation intervention (Table 1). These articles were used to provide descriptive information on patient navigation and evidence regarding its efficacy.

WHAT IS PATIENT NAVIGATION?

Several definitions of patient navigation have been published.^21-22,68-69 While variations do exist, patient navigation is generally described as a barrier-focused intervention that has the following common characteristics:

• Patient navigation is provided to individual patients for a defined episode of cancer-related care (e.g., evaluating an abnormal screening test).

• While tracking patients over time is emphasized, patient navigation has a definite endpoint where services provided are complete (e.g., patient achieves diagnostic resolution following a screening abnormality).

• Patient navigation targets a defined set of health services that are required to complete an episode of cancer-related care.

• Patient navigation services focus on the identification of individual patient-level barriers to accessing cancer care.

• Patient navigation aims to reduce delays in accessing the continuum of cancer care services, with an emphasis on timeliness of diagnosis and treatment and a reduction in number of patients lost to follow up.

WHAT DO PATIENT NAVIGATORS DO?

Despite its narrow barrier-focused definition, patient navigation has been operationalized quite broadly in practice. The term “navigator” has been applied to any type of service that assists people in overcoming obstacles from screening to treatment, as well as coping with challenges during survivorship. In our analysis of published articles that describe patient navigation services, we identified four areas where patient navigators frequently intervene: (1) overcoming health system barriers; (2) providing health education about cancer across the cancer continuum from prevention to treatment; (3) addressing patient barriers to cancer care; and (4) providing psychosocial support. To overcome health system barriers, patient navigators may coordinate cancer diagnostic or treatment care from multiple providers, assist patients with completing medical paperwork, schedule, confirm, reschedule, and attend appointments, and facilitate patient-provider communication.^{27-28,31,34,36-37,40,45,48-53,55-56,58-59,61,70} When providing health education, patient navigators provide written information, discuss diagnostic and genetic tests, discuss treatment options, and answer patients’ questions.^{28,31,34,36,45,50-53,55-56,58-59,61} To overcome patient barriers to cancer care, a patient navigator may address issues such as lack of transportation, financial and insurance barriers, lack of child care or language translation, low health literacy, or low literacy.^{28,40-41,50,53,56,70} Patient navigators also provide psychosocial or emotional support, either directly or by referring patients to social workers or cancer support groups.^{28,50-51,55-56}

HOW IS PATIENT NAVIGATION DISTINCT FROM EXISITING CANCER CARE SERVICES?

Patient navigation shares characteristics with other models of patient assistance.³⁰ For instance, hospital-based social workers may provide health education materials to oncology patients, and community health workers, lay health advisors, or promotoras may promote cancer screening in the community. In addition, case management and patient advocate models often provide similar services that patient navigators provide, but these models can also be distinctively different.

Case managers work to assist the client in achieving optimal wellness, self-management, and functional capability by linking clients with service providers and resources throughout the continuum of health and human services and care settings.⁷¹ While the principles of case management (case identification, identifying barriers to care, developing individual plans to overcome barriers, tracking over time) are embedded in patient navigation, there are distinct differences. Most importantly, patient navigation focuses on one health condition, instead of the broader goal of case management to improve health in general. In addition, patient navigation tends to track to completion of a discrete set of health services, instead of long-term follow up. Similar to patient navigators, a patient advocate helps resolve issues about health care, medical bills, and job discrimination related to a patient’s medical condition.⁷² However, the focus of patient advocates is on improving the health care system, rather than delivering care to individual patients.²⁶ While patient navigators may also perform similar tasks as patient advocates, they aim to overcome individual and logistical barriers to prevention, diagnosis, and treatment of a health concern.

WHAT ARE THE QUALIFICATIONS OF A PATIENT NAVIGATOR?

Our review of the published literature found great variation in the personnel providing patient navigation services. Patient navigation services were frequently provided by a lay patient navigator,^28-29,50,56 while several programs described navigators with undergraduate degrees,^32-33,65,67 master’s degrees,^32-33 nurse practitioners or nurses,^55,58-59 social workers,^57-58 health educators,⁵⁹ clinic staff members,⁴⁹ research assistants,^45,52 and cancer survivors.^41,59 Typically, patient navigators are paid personnel, rather than volunteers.

While it appears that most patient navigators in the United States are receiving some training, it is unclear what the quality or content of the training is. In one evaluation of patient navigation in Canada, virtually none of the patient navigators had received navigation training, however, the patient navigators evaluated were either nurses or social workers and therefore had extensive knowledge of medicine or case management.⁷³

WHAT ARE THE TARGET POPULATIONS SERVED BY PATIENT NAVIGATION PROGRAMS?

Patient navigator programs reviewed serve mainly those populations most at risk for poor cancer outcomes. The programs in our review targeted many diverse and underserved populations in the United States, including inner-city residents, ^{23,27,32-33,37,40,45,56,63,65} Native Americans,^28-29,50,53 low income populations,⁴³ minority populations,^35,49,57-58 and rural residents.⁶⁷ However, several patient navigation programs did not specifically target underserved populations^{31,36,41,51-52,55,59}. For example, patient navigation has been provided to medical center patients^{31,34,36,41,48,51,55,59,65} and patients in a managed care organization.⁵²

WHAT ARE THE INTENDED OUTCOMES OF PATIENT NAVIGATION?

Our review found most patient navigation programs have been designed to improve the outcomes for cancer in one specific site of the body, such as breast cancer. By far, most programs described in the published literature focus on improving outcomes for breast cancer.^{27-29,31-32,34,40-41,51,63,65} Other patient navigation programs target cervical cancer,^33,35,49 colorectal cancer,^45,48 prostate cancer,^57-58 lung cancer,⁵⁵ and head and neck cancer.³⁶ Only five programs reported navigation programs targeting multiple cancer sites.^{37,43,50,59,67}

WHERE IN THE CANCER CARE CONTINUUM DO PATIENT NAVIGATORS PROVIDE SERVICES?

Patient navigation services also target improving cancer outcomes across the cancer care continuum. Several programs were implemented to increase screening,^{28-29,35,45,48-49,57-58} improve follow up care following an abnormal cancer screen, ^{27-28,32-34,37,40,43,48,51,65} reduce time from diagnosis to treatment of cancer,⁵⁵ improve cancer treatment and the psychosocial experience of cancer treatment,^{34,36,40-41,56,59 67} and improve accrual and retention in clinical trials.^50,56 Less frequently, patient navigators have provided health care,⁵⁵ assisted in accrual and retention of clinical trial participants,²⁸ recruited individuals for cancer screening,²⁸ and sought to increase compliance with referrals to BRCA 1/2 genetic testing.⁵² To date, no published study has evaluated the efficacy of a patient navigation intervention for cancer survivors.

WHAT IS THE EFFICACY OF PATIENT NAVIGATION?

Sixteen studies evaluated the efficacy of a patient navigation intervention, using several different study designs (Table 1), all with different outcomes. Most studies focused on receipt of cancer diagnostic care and treatment services. Though the majority of these sixteen published studies targeted improving outcomes in diagnostic breast health services,^{27,29,32,34,41,51,63,65} none of the studies reviewed had comparable outcomes. Most published studies used prospective designs comparing participants who had received patient navigation to patients who did not receive navigation.^{29,33-35,37,41,45,52,57-58,65} Seven studies (43.8%) randomly assigned participants or clinics to a patient navigation intervention or comparison group.^{29,34,45,52,57-58,65} Two studies were limited by low sample sizes.^41,52

THE PATIENT NAVIGATION RESEARCH PROGRAM (PNRP)

The PNRP, a five-year multi-site clinical trial, is designed to provide data regarding the efficacy and cost effectiveness of the patient navigation intervention model.⁷⁴ Eight academic research institutions and one health board serving underserved populations were awarded funding in 2005. The PNRP defines patient navigation as support and guidance offered to persons with an abnormal cancer screening test or a cancer diagnosis with the goal of accessing the cancer care system and overcoming barriers to timely, quality care. In the PNRP, patient navigation targets those who are most at risk for delays in care, including racial and ethnic minorities, patients from low-income populations, uninsured patients, and patients from rural areas who have an abnormal cancer screening test for breast, cervical, colorectal, or prostate cancer. PNRP patient navigators identify individual barriers to care and then work with the health care team and other community agencies to assist patients in overcoming those barriers.