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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 5/23/23 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/RHEUMATOL | Other Identifier | UW Madison |
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The purpose of this research study is to collect information from lupus patients about their experience with a tool that informs patients about the benefits vs. harms of a medication such as hydroxychloroquine. The main question it aims to answer is whether the decision-making tool will increase medication adherence.
Participants will be asked to complete questionnaires that assess their understanding of the decision-making tool.
This study will be no different from a routine lupus or lupus nephritis clinic visit. During the same visit that a participant routinely does for lupus with their healthcare team, a healthcare team member will discuss the tool that elaborates the benefits vs. risks of lupus medications such as hydroxychloroquine. Participants will complete questionnaires that assesses their understanding of the medication (hydroxychloroquine) before and after they complete the discussion regarding the medication using the tool with the healthcare team member.
Study team members will study the data collected to answer research questions. They will analyze the data and plan better steps improve care quality in lupus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with lupus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision-making tool | Other | The shared decision-making tool is a paper tool or an electronic version which will be available in the clinics for clinic team's use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in medication adherence | Compare mean adherence at baseline and three months after completing the intervention. Mean adherence will be measured using the proportion of days covered (PDC). PDC is calculated using prescription refill data (PDC = Sum of days covered/number of days in the observation period) | Baseline to 3 months |
| Change in medication adherence - participant reported | Compare mean adherence at baseline and three months after completing the intervention. Mean adherence will be measured using participant self-report (adherence = 80% prescriptions refilled) | Baseline to 3 months |
| Change in medication adherence - blood levels | Compare mean adherence at baseline and three months after completing the intervention. Mean adherence will be measured using blood levels (adherence = 500 ng/ml or higher) | Baseline to 3 months |
| Change in proportion of adherent participants | Compare the proportion of adherent patients (Adherence = PDC ≥ 80%) at baseline v 6 months after completing intervention | Baseline to 6 months |
| Change in proportion of adherent participants - participant reported | Compare the proportion of adherent patients (Adherence = 80% prescription refills) at baseline v 6 months after completing intervention | Baseline to 6 months |
| Change in proportion of adherent participants - blood levels | Compare the proportion of adherent patients through blood levels (Adherence = 500 ng/ml or higher) at baseline v 6 months after completing intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in decisional conflict scores | Decisional conflict scores range from 0 (best) to 1 (worst) with 0.25 as an indicator of residual decisional conflict. | Baseline to 6 months |
| Assess participant satisfaction with decision-making tool |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with validated lupus diagnosis on Hydroxychloroquine (HCQ)
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| Name | Affiliation | Role |
|---|---|---|
| Shivani Garg, MD, MS | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Questionnaire | Other | Questionnaire to assess participant's understanding of the decision-making tool |
|
| Baseline to 6 months |
Participant satisfaction using a Likert scale 0-7 (7=most satisfied)
| Post-intervention, on average 6 months |
| Intervention completion | Total number of visits with participants completing the intervention during the study period | Duration of study, up to 12 months |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |