Helping Empower Liver and Kidney Patients

Not Applicable

Completed

• Conditions: Patient Education; Chronic Kidney Diseases; Hepatitis C
• Interventions: Behavioral: Decision Aid

• Registration Number: NCT03426787
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study Start: 2017-09-26
• Study First Submitted: 2018-01-21
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-08
• Primary Completion: 2018-10-15
• Results First Submitted: 2018-11-19
• Results First Submitted QC: 2019-06-28
• Results First Posted: 2019-07-05
• Study Completion: 2019-07-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decision Aid	Decision Aid	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.

Primary Outcome Measures

Name	Time	Method
Change in Knowledge	At baseline and immediately after viewing the intervention, within 30 minutes.	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.
Change in Decisional Conflict Scale	At baseline and immediately after viewing the intervention, within 30 minutes.	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.
Change in Decision Self-Efficacy Scale	At baseline and immediately after viewing the intervention, within 30 minutes.	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.

Secondary Outcome Measures

Name	Time	Method
System Usability Scale	Completed immediately after viewing the intervention	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.

Trial Locations

Locations (1)

Washington University in St. Louis School of Medicine; 🇺🇸 Saint Louis, Missouri, United States