Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 301
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Decisional Conflict Scale Scores
Study Overview
Brief Summary
The study will compare the efficacy of the usual education materials to individualized computerized decision guide on decision conflict of patients with lupus nephritis making treatment decisions regarding immunosuppressive therapies.
Detailed Description
The proposed study, a randomized controlled trial [RCT], will evaluate methods to assist minority lupus patients (African-Americans and Hispanics) to make shared decisions for the management of their lupus nephritis considering what is the best for them. We have developed an individualized patient decision guide that is culturally sensitive since it was developed solely based on the values, beliefs and preferences of minority patients. We will test the effectiveness of individualized decision aids in African-American and Hispanic lupus nephritis patients in a 2-arm randomized trial including 200 patients. We hypothesize that use of decision-aid will be associated with reduction in decisional conflict and more informed choice compared to usual care group (American College of Rheumatology [ACR] lupus pamphlet; co-primary effectiveness outcomes), both clinically meaningful and patient-centered outcomes. We chose the low-literacy decisional conflict scale as our primary outcome, since it is a validated measure, and the most commonly used outcome measure in decision aids RCTs. We use informed choice as a co-primary outcome, since this is conceptually most immediate to the intervention. It will measure whether in those with knowledge of risks and benefits of immunosuppressive drugs, patient values are concordant with their choice of immunosuppressive drug. Secondary outcomes include patient involvement in decision-making (concordance on control preference scale) and patient-physician communication (Interpersonal Processes of Care (IPC) score and analysis of audiotaped physician-patient Interaction (using the Active Patient Participation Coding Scheme (APPC)). Since we planned to recruit patients with current lupus nephritis flare (making current decision for an immunosuppressive drug) and with past lupus nephritis flares (making the same decision for a future lupus nephritis flare), two secondary outcomes (control preference scale for concordance of preferred and real role in deciding about immunosuppressive drugs and the audiotaped physician-patient interaction about immunosuppressive drugs) will be analyzed only in patients with current lupus nephritis flare, a subset of the entire cohort.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult female lupus nephritis patients, currently having a flare of lupus nephritis and considering change or initiation of an immunosuppressive medication (current flare) or had had flare of lupus nephritis in the past and at risk for a future lupus nephritis flare (future flare)
Exclusion Criteria
- •male; lupus but no lupus nephritis; change in lupus immunosuppressive treatment already made for current flare; end stage renal disease on dialysis; renal transplant or candidate for a renal transplant
Arms & Interventions
Computerized patient decision-aid
A computerized decision-aid showing benefits and harms of medications in words patients prefer
Intervention: Computerized patient decision-aid (Other)
Usual care (lupus pamphlet)
A handout/pamphlet from a non-profit organization on lupus and lupus medications (American College of Rheumatology [ACR])
Intervention: Usual care (lupus pamphlet) (Other)
Outcomes
Primary Outcomes
Change From Baseline in Decisional Conflict Scale Scores
Time Frame: Baseline and after viewing the decision-aid or the standard hand-out (pamphlet) on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)
Patient self-administered, validated measure of decisional conflict, most commonly used as the primary outcome in RCTs of decision aids (change score). The score ranges from 0 (no decisional conflict) to 100 (extreme decisional conflict). Decisional conflict represents a state of uncertainty about a choice or course of action and is more likely in situations involving high-stakes choices with important potential gains and losses, value tradeoffs in selecting a choice or a course of action (vs. the alternative) or uncertain outcomes.
Informed Choice (Validated Instruments for Values Regarding Immunosuppressives, Knowledge About Immunosuppressives, and Treatment Decision-making)
Time Frame: After viewing the guide or standard hand-out on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)
Concordance between values related (for or against starting) immunosuppressive drugs with patients' decision (to start or not start) immunosuppressive drugs, in those with adequate knowledge about benefits/harms of immunosuppressive drugs, assessed using validated instruments for values regarding immunosuppressive drugs, knowledge about immunosuppressive drugs, and treatment decision-making (patient's decision to start immunosuppressive drug).
Secondary Outcomes
- Patient Physician Communication (Interpersonal Processes of Care (IPC)(After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week))
- Control Preferences Scale: Patient Participation in Decision-making(After viewing the guide or standard hand-out on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week))
- Analysis of Audiotaped Physician-patient Interaction (Using the Active Patient Participation Coding Scheme (APPC)): Doctor Patient-centered Communication(After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week))
- Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement)(After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week))
- Acceptability (Number of Participants Rating Each Statement as "Excellent")(After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week))
Investigators
Jasvinder Singh, MD, MPH
Professor
University of Alabama at Birmingham