Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus

NCT ID: NCT02319525

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Computerized patient decision-aid

A computerized decision-aid showing benefits and harms of medications in words patients prefer

Group Type: EXPERIMENTAL

Computerized patient decision-aid

Intervention Type: OTHER

The decision-aid contained information regarding lupus and lupus nephritis, its impact on patient lives and benefits and harms of lupus nephritis treatments, focused on immunosuppressive medications compared to each other. The content of the decision-aid allowed individualization based on patient preference for details on certain aspects, as well as the desire to view additional, optional sections of the decision-aid.

Usual care (lupus pamphlet)

A handout/pamphlet from a non-profit organization on lupus and lupus medications (American College of Rheumatology \[ACR\])

Group Type: ACTIVE_COMPARATOR

Usual care (lupus pamphlet)

Intervention Type: OTHER

Patient received the standard handout/pamphlet from a non-profit organization (American College of Rheumatology \[ACR\]) regarding lupus and its treatments, that explained risks and benefits of various treatments

Interventions

Computerized patient decision-aid

The decision-aid contained information regarding lupus and lupus nephritis, its impact on patient lives and benefits and harms of lupus nephritis treatments, focused on immunosuppressive medications compared to each other. The content of the decision-aid allowed individualization based on patient preference for details on certain aspects, as well as the desire to view additional, optional sections of the decision-aid.

Intervention Type: OTHER

Usual care (lupus pamphlet)

Patient received the standard handout/pamphlet from a non-profit organization (American College of Rheumatology \[ACR\]) regarding lupus and its treatments, that explained risks and benefits of various treatments

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jasvinder Singh, MD, MPH

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jasvinder Singh, MBBS, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

Singh JA, Fraenkel L, Green C, Alarcon GS, Barton JL, Saag KG, Hanrahan LM, Raymond SC, Kimberly RP, Leong AL, Reyes E, Street RL Jr, Suarez-Almazor ME, Eakin GS, Marrow L, Morgan CJ, Caro B, Sloan JA, Jandali B, Garcia SR, Grossman J, Winthrop KL, Trupin L, Dall'Era M, Meara A, Rizvi T, Chatham WW, Yazdany J. Individualized decision aid for diverse women with lupus nephritis (IDEA-WON): A randomized controlled trial. PLoS Med. 2019 May 8;16(5):e1002800. doi: 10.1371/journal.pmed.1002800. eCollection 2019 May.

Reference Type: DERIVED

PMID: 31067237 (View on PubMed)

Singh JA, Shah N, Green C. Individualized patient decision-aid for immunosuppressive drugs in women with lupus nephritis: study protocol of a randomized, controlled trial. BMC Musculoskelet Disord. 2017 Jan 31;18(1):53. doi: 10.1186/s12891-017-1408-5.

Reference Type: DERIVED

PMID: 28143529 (View on PubMed)

Other Identifiers

CE-1304-6631

Identifier Type: -

Identifier Source: org_study_id