Study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder

The scientific literature shows a well-established association between the presence of SMD, such as schizophrenia, and poor physical health, especially in young people [10]. As compared to the general population, life expectancy in women and men with schizophrenia is 15 and 20 years lower, respectively [2]. Around a fifth of premature deaths are associated with suicide and accidents, but most are caused by physical illnesses [11], including, among others, infectious diseases such as HIV and hepatitis [12, 13]. Moreover, the risk of death from infectious disease is almost ten times higher in people with psychosis and schizophrenia, than in the general population [14].

There is evidence that patients with SMD are at an increased risk for HIV, HBV and HCV infection, as compared to the general population [15]. Generally, patients with a psychiatric illness are less aware of the transmission of infectious diseases and protective measures [16]. Risk sexual behaviours, low quality of life, or long-term hospitalization may contribute to higher infection rates in this population [15].

The prevalence of HCV infection among psychiatric patients has not been clearly established in Spain. Previous studies report a prevalence of HCV 2 to 16 times higher in SMD patients than in the general population [17‐19].

Although HCV remains virtually asymptomatic in many cases, patients with chronic infection experience a variety of symptoms that include depression, fatigue, and neurocognitive deficit, which affect their quality of life [20]. Likewise, patients with SMD are generally on treatment with neuroleptic or stabilizer drugs, which cause dejection, tiredness, and anhedonia. In addition, since SMD causes similar symptoms, this symptomatology will be rarely attributed to a physical health problem such as HCV [12].

As a result, HCV is frequently underdiagnosed and untreated in patients with SMD [6], mainly due to the side effects of interferon, the only treatment available until a few years ago. Several clinical studies reveal that immunomodulatory treatment with interferon causes numerous physical and mental side effects, mainly symptoms of depression, anxiety, psychosis, and other non-specific symptoms such as fatigue, irritability, sleep disturbances, psychomotor retardation, decreased libido, insomnia, and/or cognitive impairment [21‐25]. These side effects cause this population to poorly tolerate HCV treatment.

In the recent years, Direct Acting Antiviral therapy with proven efficacy in the general population and very limited side effects have been approved [26]. These new treatments offer the possibility of re-evaluating the SMD population for administering the new treatments to the patients who did not tolerate previous treatments.

Protocols of mental health services do not usually include routine screening for HCV, which may remain underdiagnosed and untreated [6]. In addition, HCV infection may remain active in SMD patients [21].

Nielsen et al. proposed the implementation of programs for the management of mental and physical illnesses in SMD patients coordinated by a multidisciplinary team. The purpose of these programs is to optimize treatment outcomes and reduce dropout rates [27]. Most collaborative management programs have been endorsed by associations related to mental health, diabetes, and cardiology [28].

Several studies have analysed the effectiveness of mental health nurse-led interventions in addressing many of the challenges that standard management models are unable to address. Thus, forty clinical trials evaluating nurse-led multifaceted interventions have been identified in a scoping review; many of them were aimed at assessing treatment adherence and medication management in patients with psychosis and schizophrenia [29]. As educators and counsellors, mental health nurses address barriers to adherence by using shared decision-making techniques and tools, which engage and empower patients to actively participate in decisions about their treatment [30]. These skills could be applied to improve treatment adherence, medication management, and transitional care in different healthcare settings, such as in patients with psychosis and concomitant HCV infection. The therapeutic relationship that mental health nurses build with these patients and their families is also an advantage to improve both treatment adherence and user satisfaction [31, 32].

A qualitative study developed with patients with HCV who inject drugs revealed the difficulties to access to HCV treatment and highlighted the need for nurse navigator services that help patients navigate through a complex and fragmented healthcare system [33]. Moreover, some experiences with SMD patients with physical comorbidities treated in the US Medicaid system based on a nurse-navigator model have shown promising results in the seamless management of mental and physical health problems [34]. However, for these services to be effective, a solid and consistent approach is required, with well-defined limits and sufficient resolution capacity to bridge the various gaps that arise throughout the process [35]. Ryvicker's [36] behavioral-ecological conceptual framework for navigation addresses these two requirements. Thus, individual predisposing and limiting factors determine the degree to which a patient is able to navigate effectively through the health system (educational level, health literacy, communication skills, degree of self-efficacy, support from family caregivers, among others). The complex interaction between predisposing, facilitating, limiting factors and patient’s needs end up shaping their lifestyles and health practices. Provider factors such as continuity of care from different healthcare professionals, communication or respect and trust towards patients must also be considered. The confluence of these factors influences health outcomes, generating exacerbations of chronic diseases, hospitalizations, changes in functional status or poor quality of life. Finally, this model establishes ecological determinants such as the environment of health services, the social context of the person and the environment of people's lives. In the case of people with SMD both, predisposing and limiting behavioural factors, as well as ecological ones, acquire special relevance. Thus, when a SMD patient is diagnosed with a physical illness and treatment instructions are provided to them, patients will frequently not start the treatment immediately; instead, they will probably wait to discuss it first with their psychiatrist or mental health nurse or go home and not discuss the matter ever again. There are barriers during the consultation process, follow-up, and ongoing care, both associated to the health care providers and the patient that may lead to a poor compliance with a non-psychiatric treatment [37].

The objective of this study is to compare the effectiveness of a nurse navigator program (NNP) developed by a team of mental health nurses, aimed at patients with HCV and SMD versus the usual standard of care. The variables to be assessed include HCV testing, treatment access and adherence, support for navigation throughout the healthcare system, and recovery from HCV.

The null hypothesis of this study is that there will be no differences in the HCV cure rate in SMD subjects who engage in the NNP versus those who receive the standard of care. Additionally, a second hypothesis would be that the intervention improves adherence to HCV treatment, expressed as a percentage based on the taken doses of prescribed treatment during the treatment period (from 0% to ≥ 100%).

A randomized clinical trial with blinded outcome assessment. This study has been registered in ClinicalTrials.gov (Identifier code: NCT04891445).

This study has several limitations. One of them is that all participants will be recruited in a single hospital; therefore, these findings will require replication in other settings to confirm consistency. Another possible limitation is that there are people with SMD and HCV infection who are not being treated in mental health services (homeless people with psychosis, people with poor accessibility to mental health services, etc.). To overcome this issue, members of several community SMD organizations and family associations will also be recruited.