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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision Aid | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid | Behavioral | Participants will have the option to view a web or paper-based version of the decision aid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary C Politi, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32734200 | Derived | George N, Liapakis A, Korenblat KM, Li T, Roth D, Yee J, Fowler KJ, Howard L, Liu J, Politi MC. A Patient Decision Support Tool for Hepatitis C Virus and CKD Treatment. Kidney Med. 2019 Jul 11;1(4):200-206. doi: 10.1016/j.xkme.2019.06.003. eCollection 2019 Jul-Aug. |
| Label | URL |
|---|---|
| Decisional Conflict Scale Measure | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Project HELP 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. Participants will have the option to view a web or paper-based version of the decision aid. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants completed both pre and post-test survey questions for the knowledge questions. | Posted | Mean | Standard Deviation | percentage of correct responses | At baseline and immediately after viewing the intervention, within 30 minutes. |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Project HELP 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. Participants will have the option to view a web or paper-based version of the decision aid. |
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Given the small sample and pilot study design, the reported observations can be interpreted as preliminary results. This project was also a single site study. Results might not be generalizable across other regions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary C Politi | Washington University in St. Louis School of Medicine | 3147471967 | mpoliti@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 29, 2017 | Nov 9, 2018 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2017 | Nov 9, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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pre-post within subjects design
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| Decision Self-Efficacy Scale Measure | View source |
| Usability Scale Measure | View source |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Type of Insurance Coverage | Count of Participants | Participants |
|
Participants knowledge scores after using intervention |
|
|
|
| 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. | Participants completed both pre and post-test survey questions for the decisional conflict scale. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants completed both pre and post-test survey questions for the decision self-efficacy scale. | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants completed the system usability scale in our post-test questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Completed immediately after viewing the intervention |
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| 1 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |