Clarifying Misbeliefs About Hydroxychloroquine: Developing a Decision Aid for Patients With Lupus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clarifying Misbeliefs About Hydroxychloroquine (HCQ): Developing an Individualized Decision Aid for Diverse Patients With Lupus (HCQ-IDEAL)

Conditions
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Lupus

Intervention / Treatment
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* Other: Decision-making tool
* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with lupus<br> | Other: Decision-making tool<br>* 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.<br>Other: Questionnaire<br>* Questionnaire to assess participant's understanding of the decision-making tool<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hydroxychloroquine