Chronic Kidney Diseases, Hepatitis C, Patient Education
Conditions
Keywords
Patient Centered, Pre-Post Design, Decision Support, Health Literacy
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.
Interventions
BEHAVIORALDecision Aid
Participants will have the option to view a web or paper-based version of the decision aid.
Sponsors
Merck Sharp & Dohme LLC
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
pre-post within subjects design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decision Support Tool 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.
Decision Aid: Participants will have the option to view a web or paper-based version of the decision aid. | 56 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Unrelated to intervention death | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Decision Support Tool |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age, Continuous | 60.95 years STANDARD_DEVIATION 6.58 |
| Education College degree or highe | 5 Participants |
| Education High school diploma or GED | 13 Participants |
| Education Less than or some high school | 22 Participants |
| Education Some college | 11 Participants |
| Education Technical Training or Certification | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 35 Participants |
| Type of Insurance Coverage Governmental (Medicaid, Medicare, & VA/TriCare | 52 Participants |
| Type of Insurance Coverage Private | 2 Participants |
| Type of Insurance Coverage Uninsured | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 70 |
| other Total, other adverse events | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
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.
Time frame: At baseline and immediately after viewing the intervention, within 30 minutes.
Population: Participants completed both pre and post-test survey questions for the decisional conflict scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Knowledge Pre-Test Scores | Change in Decisional Conflict Scale | 2.64 score on a scale | Standard Deviation 1.38 |
| Knowledge Post Test Scores | Change in Decisional Conflict Scale | 3.13 score on a scale | Standard Deviation 1.4 |
p-value: 0.046395% CI: [-0.9355, -0.00793]t-test, 2 sided
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.
Time frame: At baseline and immediately after viewing the intervention, within 30 minutes.
Population: Participants completed both pre and post-test survey questions for the decision self-efficacy scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Knowledge Pre-Test Scores | Change in Decision Self-Efficacy Scale | 84.42 score on a scale | Standard Deviation 17.07 |
| Knowledge Post Test Scores | Change in Decision Self-Efficacy Scale | 86.62 score on a scale | Standard Deviation 18.88 |
p-value: >0.0595% CI: [-7.4086, 3.5365]t-test, 2 sided
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.
Time frame: At baseline and immediately after viewing the intervention, within 30 minutes.
Population: Participants completed both pre and post-test survey questions for the knowledge questions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Knowledge Pre-Test Scores | Change in Knowledge | 53.54 percentage of correct responses | Standard Deviation 21.31 |
| Knowledge Post Test Scores | Change in Knowledge | 65.74 percentage of correct responses | Standard Deviation 22.8 |
p-value: <0.00195% CI: [-18.95, -5.6531]t-test, 2 sided
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.
Time frame: Completed immediately after viewing the intervention
Population: Participants completed the system usability scale in our post-test questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Knowledge Pre-Test Scores | System Usability Scale | 69.86 score on a scale | Standard Deviation 20.43 |