Helping Empower Liver and Kidney Patients

Hepatitis C Clinical Trial

— Project HELP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426787
• Other study ID #: 201707154
• Status: Completed
• Phase: N/A
• Start date: September 26, 2017
• Est. completion date: July 30, 2019

Study information

• Verified date: September 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 30, 2019
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hepatitis
• Hepatitis C
• Kidney Diseases
• Patient Education
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Decision Aid
Participants will have the option to view a web or paper-based version of the decision aid.

Locations

Country	Name	City	State
United States	Washington University in St. Louis School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knowledge	The percent correct out of eight questions created by the research team based on information that is considered vital to making treatment decisions, including understanding HCV and CKD, the health effects of both diseases, and understanding factors that differentiate treatment options. Scores range from 0 to 100. Higher scores demonstrate more knowledge.	At baseline and immediately after viewing the intervention, within 30 minutes.
Primary	Change in Decisional Conflict Scale	The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice and feel they have enough support to make a choice. Scores range from 0 to 4. Higher scores indicate more confidence in their choice.	At baseline and immediately after viewing the intervention, within 30 minutes.
Primary	Change in Decision Self-Efficacy Scale	The validated decision self-efficacy scale will be used. This 11-item scale measures an individual's self-confidence or belief in their ability to make a decision. Individuals will be asked to rate how confident they feel taking actions involved in making an informed choice (e.g., gathering information, asking questions, and expressing opinions). Scores can range from 0 to 100. Higher scores indicate more confidence in participants ability to make a treatment choice.	At baseline and immediately after viewing the intervention, within 30 minutes.
Secondary	System Usability Scale	A 10-item scale that evaluates the website's usability level. Scores can range from 0 to 100. An average score of 68 is considered a usable/adequate tool per measure guidelines. Higher scores represent better usability level for the tool.	Completed immediately after viewing the intervention

External Links

•   Decision Self-Efficacy Scale Measure
•   Decisional Conflict Scale Measure
•   Usability Scale Measure