Project HELP: a study protocol to pilot test a shared decision-making tool about treatment options for patients with hepatitis C and chronic kidney disease

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.

Pharmacokinetics and important drug–drug interactions to remember when treating advanced chronic kidney disease patients with hepatitis C direct acting anti‐viral therapy

“…It is important for providers to recognize this population of patients with co‐morbid chronic HCV and CKD as a “special patient population” and to take care to consider from all angles‐ most appropriate regimen selection, timing of therapy, and drug–drug interactions. The HCV DAA revolution has allowed for a new clinical paradigm in guiding care of patients with co‐morbid HCV and ESRD seeking kidney transplantation including consideration of a delay in therapy and acceptance of HCV viremic organs for both viremic and non‐viremic recipients . This is addressed elsewhere in detail within this special Seminars in Dialysis issue.…”

A user‐centered approach to the development of a diet education tool for older adults with tooth loss

“…Similar success with user-centered design has been demonstrated in the development of paper and electronic tools for both patients and clinicians. [23][24][25][26][27][28][34][35][36][37][38][39] Methodologies for tool development include semi-structured patient and caregiver interviews, interviews with clinicians / health care providers, focus groups led by trained facilitators, panel discussions with expert clinicians and/or stakeholders, and direct observation of patient and clinician interaction with the tool. However, the research surrounding field testing methodology in healthcare is heterogeneous.…”

“…However, the research surrounding field testing methodology in healthcare is heterogeneous. [34][35][36][37][38][39] Multiple types of tools (education, decision making, other) in multiple formats (print, audio-visual, electronic, web-based) have been field or pilot tested for usability using various methods (including questionnaires, interviews, and direct observation) with patients and health care providers. [34][35][36][37][38][39] These processes resulted in tool revision, improved patient acceptability, and supported feasibility.…”

A Patient Decision Support Tool for Hepatitis C Virus and CKD Treatment

“…We developed a patient education and decision support tool with an advisory board, which consists of patients, nephrologists, and hepatologists through the HELP (Helping Empower Liver and Kidney Patients) study. 26 This tool provides: (1) plain language information about treatment options for HCV infection and CKD; (2) education that is tailored to a user’s self-reported prior treatments, current stages of CKD and liver fibrosis, and additional medical conditions; (3) an assessment to elicit users’ values that may influence their choice of treatment; and (4) a printable summary page that can facilitate patient-clinician discussions about treatment needs, values, and questions.…”