Helping Empower Liver and Kidney Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/12/2018 |
| Start Date: | September 26, 2017 |
| End Date: | July 30, 2019 |
| Contact: | Nerissa George, MPH |
| Email: | n.george@wustl.edu |
| Phone: | 314-747-5657 |
Development and Validation of a Shared-decision Making Tool for Initiation of Treatment in Patients With Hepatitis C Infection and Advanced Chronic Kidney Disease
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.
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.
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.
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.
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
We found this trial at
1
site
Saint Louis, Missouri 63110
Principal Investigator: Mary C Politi, PhD
Phone: 314-747-5657
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