Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus

Systemic Lupus Erythematosus Clinical Trial

Official title: Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

• NCT number: NCT02319525
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Completion date: December 2016