Abstract
BackgroundRecent advances in treatment have given patients with chronic kidney disease (CKD) access to safer and more effective medications to treat comorbid hepatitis C virus (HCV) infection. Given the variety and complexity of treatment options that depend on patients’ clinical characteristics and personal preferences, education and decision support are needed to prepare patients better to discuss treatment options with their clinicians.MethodsDrawing on International Patient Decision Aids Standards guidelines, literature reviews, and guidance from a diverse expert advisory group of nephrologists, hepatologists, and patients, we will develop and test a HCV and CKD decision support tool. Named Project HELP (Helping Empower Liver and kidney Patients), this tool will support patients with HCV and CKD during decisions about whether, when, and how to treat each illness. The tool will (1) explain information using plain language and graphics; (2) provide a step-by-step process for thinking about treating HCV and CKD; (3) tailor relevant information to each user by asking about the individual’s stage of CKD, stage of fibrosis, prior treatment, and comorbidities; (4) assess user knowledge and values for treatment choices; and (5) help individuals use and consider information appropriate to their values and needs to discuss with a clinician. A pilot study including 70 individuals will evaluate the tool’s efficacy, usability, and likelihood of using it in clinical practice. Eligibility criteria will include individuals who understand and read English, who are at least 18 years old, have a diagnosis of HCV (any genotype) and CKD (any stage), and are considering treatment options.DiscussionThis study can identify particular characteristics of individuals or groups that might experience challenges initiating treatment for HCV in the CKD population. This tool could provide a resource to facilitate patient-clinician discussions regarding HCV and CKD treatment options.
Highlights
Recent advances in treatment have given patients with chronic kidney disease (CKD) access to safer and more effective medications to treat comorbid hepatitis C virus (HCV) infection
The preliminary content of the decision aid will be based on Kidney Disease: Improving Global Outcomes (KDIGO) guidelines [17], the joint American Association for the Study of Liver Disease- Infectious Disease Society of America’s [22] combined guidelines and graded evidence, and our advisory board feedback
To measure patients’ knowledge, we will develop items based on information that is considered vital to making treatment decisions, understanding what is HCV and CKD, the health effects of both diseases, and understanding facts that differentiate treatment options [34]
Summary
The content for this decision aid will be based on literature reviews and guidance from a diverse expert advisory group consisting of three nephrologists, three hepatologists, and two patients. To measure patients’ knowledge, we will develop items based on information that is considered vital to making treatment decisions, understanding what is HCV and CKD, the health effects of both diseases, and understanding facts that differentiate treatment options [34]. Secondary outcomes and potential covariates include factors that could influence decisions and quality of life such as clinical characters (e.g., CKD severity, stage of liver fibrosis, HCV genotype, prior treatment history of HCV and length of diagnosis, and comorbidities), demographics, health literacy [38], patients’ preferred decision role, and financial toxicity [39]. Data will be examined for within group differences in outcomes (knowledge, decisional conflict, decision selfefficacy) among patients pre- and post-use of the DA in a multivariable linear regression model controlling for up to 5 independent covariates (e.g., age, stage of liver fibrosis, health literacy, CKD stage, and prior history of HCV treatment). Prior history of HCV treatment will be included as a covariate in the model with knowledge as an outcome
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