Helping Empower Liver and Kidney Patients (Project HELP)

The Washington University

Status: Completed

Conditions: Chronic Kidney Diseases; Hepatitis C; Patient Education

Treatments: Behavioral: Decision Aid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03426787

201707154

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Decision Aid

Experimental group

Description:

A decision supports tool that guides patients with Hepatitis C and Chronic Kidney Disease through choices about whether, when, and how to treat each illness.

Treatment:

Behavioral: Decision Aid