Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Other: Computerized patient decision-aid; Other: Usual care (lupus pamphlet)

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 Type: Interventional
• Enrollment (Actual): 301
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computerized patient decision-aid; A computerized decision-aid showing benefits and harms of medications in words patients prefer	Other: 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.
Active Comparator: Usual care (lupus pamphlet); A handout/pamphlet from a non-profit organization on lupus and lupus medications (American College of Rheumatology [ACR])	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Decisional Conflict Scale Scores	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.	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)
Informed Choice (Validated Instruments for Values Regarding Immunosuppressives, Knowledge About Immunosuppressives, and Treatment Decision-making)	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).	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Control Preferences Scale: Patient Participation in Decision-making	This scale assessed how much decision-making control they would like to have versus actually experienced. There are 5 responses for 5 control options: active, active shared, collaborative, passive shared and passive, which were collapsed into active (active, active shared), collaborative, and passive (passive shared and passive), as previously (and pre-specified). Concordance was assessed between desired and actual role played by each patient. We present these data for patients with current flare only, since only they were making a decision about the immunosuppressive drugs; patients with past lupus flare were not included in the denominator.	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)
Patient Physician Communication (Interpersonal Processes of Care (IPC)	This was assessed using the interpersonal processes of care (IPC), an 18-item validated patient-reported measure of patient-physician communication and care processes. The score ranges from 18 (worst) to 90 (best) and the scale is a patient-reported measure of patient-physician communication and care processes.	After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)
Analysis of Audiotaped Physician-patient Interaction (Using the Active Patient Participation Coding Scheme (APPC)): Doctor Patient-centered Communication	This was done by analyzing the audio-recorded patient-physician discussion in patients with current lupus nephritis flare. The APCC is a validated instrument to measure 'active patient participation.' APCC assesses indicators and facilitators of patient participation. The unit of coding is the utterance, the oral analogue of a sentence. The range is 0 to unlimited. Patient participation is measured by the number of questions, number of concerns expressed, and act of assertiveness (e.g., preferences, introducing topics, making requests). These are 'active' forms of participation because of their influence on clinician behavior and the structure and content of the consultation. The APPC also assess clinician behaviors that facilitate and support patient participation, partnership-building and supportive talk (e.g., reassurance, empathy). We present doctor patient-centered communication. higher scores indicates better patient participation and communication.	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")	Acceptability of the decision-aid (information quality and quantity, presentation style and usefulness) was assessed using a validated acceptability survey on 4-point scale ranging from "excellent" to "poor" (response options were: excellent, good, fair and poor). The number of patients rating each of the five statements as "excellent" (vs. other ratings) was compared between the two treatment arms.	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)	Feasibility of the decision-aid vs. pamphlet was assessed using a single statement "The education guide was easy to use". Patients rated this on 5-point ordinal scale ranging from "strongly agree" to "strongly disagree" (response options were: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). The number of patients was compared between the two treatment arms.	After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Jasvinder Singh, MBBS, MPH, University of Alabama at Birmingham

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: December 13, 2014
• First Posted (Estimate): December 18, 2014

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: treatment; SLE; lupus nephritis; lupus; decision-aid; decision-making; minorities; immunosuppressive medications; Decision conflict
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: CE-1304-6631 (Other Grant/Funding Number: PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE (PCORI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No