Lupus
Conditions
Keywords
hydroxychloroquine
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.
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.
Interventions
OTHERDecision-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.
OTHERQuestionnaire
Questionnaire to assess participant's understanding of the decision-making tool
Sponsors
University of Wisconsin, Madison
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in proportion of adherent participants - blood levels | Baseline to 6 months | Compare the proportion of adherent patients through blood levels (Adherence = 500 ng/ml or higher) at baseline v 6 months after completing intervention |
| Change in medication adherence - blood levels | Baseline to 3 months | 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) |
| 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 |
| Change in proportion of adherent participants - participant reported | Baseline to 6 months | Compare the proportion of adherent patients (Adherence = 80% prescription refills) at baseline v 6 months after completing intervention |
| Change in medication adherence - participant reported | Baseline to 3 months | 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
United States
Outcome results
None listed