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.
Study Type
OBSERVATIONAL
Enrollment
200
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.
Questionnaire to assess participant's understanding of the decision-making tool
University of Wisconsin
Madison, Wisconsin, United States
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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to 6 months
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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.
Time frame: Baseline to 6 months
Assess participant satisfaction with decision-making tool
Participant satisfaction using a Likert scale 0-7 (7=most satisfied)
Time frame: Post-intervention, on average 6 months
Intervention completion
Total number of visits with participants completing the intervention during the study period
Time frame: Duration of study, up to 12 months