Clinical trial NCT03426787: Helping Empower Liver and Kidney Patients
Official title: Development and Validation of a Shared-decision Making Tool for Initiation of Treatment in Patients With Hepatitis C Infection and Advanced Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Chronic Kidney Diseases
Patient Education
Keywords: Patient Centered
Pre-Post Design
Decision Support
Health Literacy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2018-02-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pre-post within subjects design
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall purpose of this study is to develop and test a web-based decision aid (DA) to support patients with Hepatitis C and Chronic Kidney Disease during decisions about whether, when, and how to treat each illness. Patients will have the opportunity to learn about their hepatitis C and kidney disease, initiate thought about what matters most to them and choose a treatment plan for their liver and kidney disease that works best for them. Investigators will evaluate the tool's efficacy, usability, and the likelihood of using it in clinical practice. There are three (3) primary aims of this project: (1) to develop the DA; (2) to pilot-test the DA to determine efficacy, usability and likelihood of using it in routine practice; (3) to explore stakeholders feedback on the usefulness of the DA and likelihood of implementing the tool.

Detailed description: First, for Aim 1, Investigators along with direction from a diverse expert advisory group of nephrologists, hepatologists, and patient partners developed a decision aid based upon International Patient Decision Aids Standards guidelines, literature reviews, and expert advisory reviews. It includes plain language education, interactive learning modules personalized tailored information to help individuals use and consider information appropriate to their values and needs, and guidance on discussions with clinicians about treatment goals. Second, for Aim 2, Investigators will pilot-test the decision aid with 70 individuals in a pre-post within-subjects study design to evaluate the tool's efficacy, usability, and the likelihood of using it in clinical practice. Lastly, for Aim 3, Investigators will conduct 30 semi-structured qualitative interviews with both clinicians and participants after the pilot evaluation of the decision aid to gather feedback about implementing the tool into clinical practice.

Eligibility criteria: Inclusion Criteria:

* Must read and understand English AND
* Must have Hepatitis C (any genotype) and Chronic Kidney Disease (any stage)

Exclusion Criteria:

* Developed jaundice, ascites, variceal hemorrhage, or hepatic encephalopathy also known as Decompensated cirrhosis; or
* Currently has or had liver cancer (Hepatocellular carcinoma); or
* Received a liver transplant

Primary outcomes:
measure: Change in Knowledge
timeFrame: At baseline and immediately after viewing the intervention, within 30 minutes.
measure: Change in Decisional Conflict Scale
timeFrame: At baseline and immediately after viewing the intervention, within 30 minutes.
measure: Change in Decision Self-Efficacy Scale
timeFrame: At baseline and immediately after viewing the intervention, within 30 minutes.
Secondary outcomes:
measure: System Usability Scale
timeFrame: Completed immediately after viewing the intervention
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Mary C Politi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: George N, Liapakis A, Korenblat KM, Li T, Roth D, Yee J, Fowler KJ, Howard L, Liu J, Politi MC. A Patient Decision Support Tool for Hepatitis C Virus and CKD Treatment. Kidney Med. 2019 Jul 11;1(4):200-206. doi: 10.1016/j.xkme.2019.06.003. eCollection 2019 Jul-Aug.