HCQ-IDEAL: Clarifying Misbeliefs About Hydroxychloroquine: Developing a Decision Aid for Patients With Lupus
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants with lupus
|
Other: Decision-making tool
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.
Other: Questionnaire
Questionnaire to assess participant's understanding of the decision-making tool
|
Outcome Measures
Primary Outcome Measures
- Change in medication adherence [Baseline to 3 months]
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)
- Change in proportion of adherent participants [Baseline to 6 months]
Compare the proportion of adherent patients (Adherence = PDC ≥ 80%) at baseline v 6 months after completing intervention
Secondary Outcome Measures
- Change in decisional conflict scores [Baseline to 6 months]
Decisional conflict scores range from 0 (best) to 1 (worst) with 0.25 as an indicator of residual decisional conflict.
- Assess participant satisfaction with decision-making tool [Post-intervention, on average 6 months]
Participant satisfaction using a Likert scale 0-7 (7=most satisfied)
- Intervention completion [Duration of study, up to 12 months]
Total number of visits with participants completing the intervention during the study period
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age ≥ 18 years
-
validated SLE diagnosis
-
no absolute contraindication to HCQ (e.g., retinopathy)
-
prior HCQ therapy for at least 3-6 months
Exclusion Criteria:
-
participants with other autoimmune diseases
-
participants who are not taking HCQ
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Wisconsin | Madison | Wisconsin | United States | 53705 |
Sponsors and Collaborators
- University of Wisconsin, Madison
Investigators
- Principal Investigator: Shivani Garg, MD, MS, University of Wisconsin, Madison
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-0846
- Protocol Version 5/23/23
- SMPH/MEDICINE/RHEUMATOL