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

Abstract

Rationale & Objective Patient education and decision support tools could facilitate decisions around the timing of antiviral therapy in patients living with both hepatitis C virus (HCV) infection and chronic kidney disease (CKD). We previously developed a tool through the HELP (Helping Empower Liver and Kidney Patients) study. This article evaluates the preliminary efficacy and usability of the tool among participants with both HCV infection and CKD. Study Design Pre-post study pilot evaluation. Setting & Participants Participants were at least 18 years old, were English speaking, and had a diagnosis of chronic HCV infection and CKD; they were seen in CKD clinics, dialysis units, and/or hepatology and liver transplantation clinics. Intervention Electronic patient decision support tool. Outcomes Participants’ change in knowledge, certainty about choice, decision self-efficacy, patients’ treatment preferences, and tool usability. Results 70 participants were recruited; 56 of 70 (80.0%) completed study procedures. Nearly all (51/56; 91.1%) requested paper-based study procedures despite the electronic design of the tool. Participants reported that they were most worried about the following treatment factors: (1) cost of drugs to treat HCV infection, (2) how their HCV infection affected their CKD, and (3) wait times for a kidney transplant. After using the decision tool, participants had significantly higher HCV infection and CKD knowledge (mean posttest percent of questions answered correctly = 65.74% vs pretest percent of questions answered correctly = 53.44%; P < 0.001) and more certainty about choice (mean posttest = 3.13 vs pretest = 2.65; P = 0.05). There were no significant changes in decision self-efficacy (mean posttest = 86.62 vs pretest = 84.68; P = 0.48). Limitations Single-site pilot study to explore preliminary tool efficacy and usability. Conclusions This study suggests that a decision tool may support informed patient-centered choices among patients with HCV infection and CKD. Future studies should evaluate ways to improve care decisions in a larger sample using both paper-based and electronic materials. Funding Merck & Co, Inc, Kenilworth, NJ. Trial Registration Registered at clinicaltrials.gov with study number NCT03426787 .

Implementing a Health Utility Assessment Platform to Acquire Health Utilities in a Hemodialysis Outpatient Setting: Feasibility Study

“…Prior studies noted the potential benefits of using HCV-viremic kidneys to expand the pool of organs available to hemodialysis patients, thus reducing waiting times for transplantation and providing opportunities for transplantation in patients who might not have received a kidney otherwise. Cost-effectiveness analyses have shown the strategy to be cost-effective at a policy level for the general population of patients with ESKD [ 13 , 22 ]. However, none of these analyses used utility assessments from actual patients for the outcome transplant with an HCV-viremic kidney [ 31 , 32 ].…”

“…These include the visual analog scale (VAS), standard gamble (SG), and time trade-off (TTO) [ 12 ] ( Multimedia Appendix 1 A). The utility assessment process itself provides an opportunity to educate patients about the health states for which values and preferences are being sought [ 13 , 14 ]. The Gambler II uses video clips of patient actors to describe health states.…”

Discussing Cost and Value in Patient Decision Aids and Shared Decision Making: A Call to Action

“…57,58 After discussing relative costs of options (or more precise costs if known or included from insurance support and/or cost comparison tools 43,45,46,59 ), there are referrals that clinicians or PtDAs can suggest for members of care teams that can help patients navigate the specific direct or indirect cost implications of care (e.g., social workers, financial navigators, insurance representatives, community resources), although few currently do so. 21,48 By mentioning costs and helping patients consider those costs in the context of SDM, patients could seek support earlier to better prepare for direct and indirect costs, should they continue to choose or need expensive or Financial toxicity (burden of high costs of care) is prevalent across conditions and countries [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16] Clinicians rarely bring up costs without prompts and training Patients want clinicians to bring up costs as part of treatment discussions, in some contexts finding clinicians trustworthy, honest, and transparent when they address costs 24 Patients often worry that if they bring up cost, it will lead to biases and lower-quality care [26][27][28] Patient decision aids and standards rarely include relative costs to compare options 53,54 When costs are discussed, they rarely include downstream direct or indirect costs (e.g., costs that build over time, relating to frequent monitoring or ongoing morbidity) 31 Making space to ask about costs supports broader care goal conversations and practical issues affecting implementation 31,32,55 Table 2 Summary of Action Items ...…”

“…It’s a big part of it.” 8 Another commented, “You know, it took about three-and-a-half years to pay off my surgeries.” 8 Although financial toxicity is often discussed in the context of cancer, it also affects patients with long-term illnesses such as hepatitis C virus, chronic kidney disease, cardiovascular disease, rheumatoid arthritis, and diabetes. 9 – 11 …”

Facilitating Patient-Centered Decision Making Around the Timing of Direct-Acting Antivirals in Patients With Hepatitis C Virus and CKD

“…In this issue of Kidney Medicine, George et al 23 present results of a pilot study evaluating the feasibility and utility of a tool for educating patients with CKD and HCV infection about the timing of DAA therapy. The study used a pre-post exposure design to assess participants' improvement in decision self-efficacy, conflict, and knowledge after using the patient education and decision Related article, p. 200 support tool.…”